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UNIVERSITY OF THE PHILIPPINES PHILIPPINE GENERAL HOSPITAL

DEPARTMENT OF OTORHINOLARYNGOLOGY

with the continuing medical education support of


GLAXO SMITHKLINE PHILIPPINES

CLINICAL PRACTICE GUIDELINES


RUZANNE MAGIBA-CARO MD

EDILBERTO M. JOSE MD
Co-chairs

ERASMO GONZALO D.V. LLANES MD


CHRISTINE JOY S. ARQUIZA MD
CHRISTOPHER MALORRE E. CALAQUIAN MD
JOSE ROBERTO V. CLARIDAD MD
ERICK G. DUCUT MD

JASON S. GUEVARA MD
VINCENT MARK M. JARDIN MD
JERIEL JOHN C. MAJAM MD
DANILO R. LEGITA MD

CONSENSUS PANEL
GENEROSO T. ABES MD MPH
Department Chair
MARIANO B. CAPARAS MD
JOSELITO C. JAMIR MD
EUTRAPIO S. GUEVARA JR MD
ALFREDO Q.Y. PONTEJOS JR MD
JAIME F. FLOR MD
JOSEFINO G. HERNANDEZ MD
RENE S. TUAZON MD
JACOB S. MATUBIS MD
CESAR V. VILLAFUERTE JR MD MHA
CHARLOTTE M. CHIONG MD
ABNER L. CHAN MD
FELIX P. NOLASCO MD

ROMEO L. VILLARTA, JR. MD MPH


JOSE FLORENCIO F. LAPEA, JR. MA MD
TERESA LUISA I. GLORIA-CRUZ MD MHPEd
RAMON ANTONIO B. LOPA MD
ROBERTO M. PANGAN DMD MD PhD
MARIA RINA T. REYES-QUINTOS MD MCAud
MELFRED L. HERNANDEZ MD MHA
NATHANIEL W. YANG MD
ARMANDO M. CHIONG, JR. MD
AGNES N. TIRONA-REMULLA MD
JEANNETTE MARIE S. MATSUO MD

RESIDENTS
LINA ROSE A. ALCANCES MD MOH
ERWIN M. ESLAVA MD
HERBERT Q. GUTIERREZ MD
ERIC T. VINCULADO MD
MARIO ADRIAN M. ZAFRA MD
FORTUNA CORAZON A. ABERIN MD
ARSENIO CLARO A. CABUNGCAL MD
RYNER JOSE C. CARRILLO MD
PHILIP B. FULLANTE MD

MICHAEL F. GALICIA MD
DESIREE B. VANGUARDIA MD
CAMILLE SIDONIE A. ESPINA MD
MARY APPLE PIE M. GARCIA MD
FELICIDAD B. MENDOZA MD
LEI-JOAN V. MOLO MD
IVY D. PATDU MD
FLORENCE YUL N. SAQUIAN MD
JOSEPH ROY VINCENT B. UMALI MD

UP-PGH DEPARTMENT OF OTORHINOLARYNGOLOGY CLINICAL PRACTICE GUIDELINES


PURPOSE OF THE CLINICAL PRACTICE GUIDELINES
The UP-PGH Department of Otorhinolaryngology handles about 45,000 patients a year. It must
ermbrace the influx of new concepts, current techniques, diagnostic and therapeutic options. At
the same time, it has to struggle to keep a balance between this and the availability of its limited
resources. The development of clinical practice guidelines in selected areas is designed to help
fill in the gap to maximize patient care in the department.
TARGET POPULATION, SETTING AND PROVIDERS OF CARE
Charity patients seen by the consultant and resident staff of the UP-PGH Department of
Otorhinolaryngology are the target population. The conditions include: (1) chronic suppurative
otitis media in adults; (2) nasal polyps in adults; (3) acute and chronic tonsillitis in children and
adults; (4) obstructive sleep apnea in children; (5) thyroid masses in adults; (6) cleft lip and palate
in children and adolescents; and (7) tracheostomy and decannulation in children and adults.
METHODS OF GUIDELINE DEVELOPMENT
The UP-PGH Department of Otorhinolaryngology has six subspecialty study groups to which
consultants and residents are assigned. Each of the study groups chose one common clinical
condition, which they felt needed a protocol for effective and efficient management. They
conducted the literature search and developed evidence-based recommendations (EBR). In the
case of the Cranio-Maxillofacial, Plastic and Reconstructive Surgery study group, they met with
the rest of the CLAP team in the development of the EBR. The consultant and resident staff
convened in Caliraya, Laguna on September 2-3, 2003, to deliberate on the EBRs, modify, arrive
at a consensus and ratify the CPG.
PANEL RECOMMENDATIONS AND LEVELS OF EVIDENCE
All literature were classified according to levels of evidence and grades of recommendations
based on guidelines from the US Agency for Health Care Policy and Research and are set out as
follows:

Ia
Ib

IIa

IIb

III

IV

STATEMENTS OF EVIDENCE
Obtained from meta-analysis of
randomized controlled trials
Obtained from at least one
randomized controlled trial
Obtained from at least one welldesigned controlled study without
randomization
Obtained from at least one other type
of well-designed quasi-experimental
study
Obtained from well-designed nonexperimental descriptive studies, such
as comparative studies, correlation
studies and case studies
Obtained from expert committee
reports or opinions and/or clinical
experience of respected authorities

GRADES OF RECOMMENDATION
Requires at least one randomized
A
controlled trial as part of a body of
literature of overall good quality and
consistency addressing the specific
recommendation
Requires the availability of well
B
conducted clinical trials but no
randomized clinical trials on the topic of
recommendation

Requires evidence obtained from


expert committee reports or opinions
and/or clinical experiences of
respected authorities. Indicates an
absence of directly applicable clinical
studies of good quality

UP-PGH DEPARTMENT OF OTORHINOLARYNGOLOGY CLINICAL PRACTICE GUIDELINES


CHRONIC SUPPURATIVE OTITIS MEDIA IN ADULTS
SCOPE OF THE PRACTICE GUIDELINE
This clinical practice guideline is for use by the Department of Otorhinolaryngology of the College
of Medicine - Philippine General Hospital, University of the Philippines Manila. It covers the
diagnosis and management of chronic suppurative otitis media in adults (19 years old and
above).
OBJECTIVES
The objectives of the guideline are (1) to emphasize the requisites of diagnosis of chronic
suppurative otitis media in adults; (2) to evaluate current diagnostic techniques; and (3) to
describe treatment options.
LITERATURE SEARCH
This guideline is based on the 1997 Clinical Practice Guidelines of the Philippine Society of
Otolaryngology Head and Neck Surgery and revised according to new evidence. The National
Library of Medicines PubMed database and Cochrane Reviews database were searched for
literature using the keyword otitis media, suppurative. The search was limited to articles involving
humans and those published in English in the last fifteen years, WHO reports, and the PGH
Annual Report. It yielded 549 articles. Thirty-eight (38) abstracts were chosen and results were
further assessed for relevance. Full text articles were obtained when possible. The chosen
articles were divided as follows:
Meta-analysis
Randomized controlled trial
Non-randomized controlled study
Descriptive study
Committee report

2
2
3
1
1

DEFINITION
Chronic suppurative otitis media (CSOM) is a persistent inflammation of the middle ear or
mastoid cavity. Synonyms include chronic otitis media (without effusion), chronic mastoiditis
and chronic tympanomastoiditis. Chronic suppurative otitis media is characterized by persistent
or recurrent ear discharge (otorrhea) over 3 months through a perforation of the tympanic
9
membrane. Typical findings may include thickened granular middle ear mucosa, mucosal polyps
and cholesteatoma within the middle ear. Chronic suppurative otitis media does not include
chronic perforations of the eardrum that are dry, discharge only occasionally, and have no signs
2
of active infection.
PREVALENCE
Worldwide prevalence of chronic suppurative otitis media is 65-330 million people. Between 39
to 200 million (60%) suffer from significant hearing impairment. Otitis media has been estimated
to cost 28,000 deaths and a loss of over 2 million in Disability Adjusted Life Years (DALY) in
2000, 94% of which are in developing countries. Most of these deaths are presumably due to
2
chronic suppurative otitis media, because acute otitis media is a self-limiting infection .
In the Philippines, the prevalence of CSOM is estimated at 2.5% to 29.5% based on several
9
surveys among children in Metro Manila and Mindanao. It has been reported that CSOM
4
patients constitute 14% of outpatient consults at the University of Santo Tomas Hospital , and
9
30% of emergency cases and 60% of operated ears at the PGH . The number of referrals

(pediatric and adult patients) with diagnosis of CSOM in the ORL-Outpatient Ear Specialty Clinic
of the Philippine General Hospital numbers to 325 in 2002.
RECOMMENDATIONS ON THE DIAGNOSIS OF CHRONIC SUPPURATIVE OTITIS MEDIA
The assessment begins with a thorough history of the frequency, duration, and characteristics of
the discharge. Physical examination of the affected ear requires cleansing of the external
auditory canal before the tympanic membrane can be accurately assessed. The eardrum must
6
be adequately visualized for accurate diagnosis and treatment.
1. CSOM is diagnosed by the presence of a tympanic membrane perforation and a history
of persistent or recurrent ear discharge for more than 3 months.
Grade C Recommendation
The presence of tympanic membrane perforation and persistent or recurrent otorrhea for
more than 3 months is still considered by the panel to be diagnostic of CSOM. (Task Force of
4
the Fourth International Symposium of Otitis Media Florida, June 1987). Critical to this
definition is the history of chronic active otorrhea for more than 3 months.
The
histopathologic definition of CSOM was not used.
2. Pure tone audiometry and speech testing (PTA-ST) must be performed as part of the
total diagnostic assessment.
Grade C Recommendation
The panel recognized the value of the PTA-ST in the initial evaluation of patients with CSOM
because it provides information on the etiology of hearing loss (conductive, mixed and
sensorineural) in the ipsilateral and contralateral ear. Moreover, it gives baseline data on the
pre-operative hearing status of a patient, which is important in surgical planning and in
evaluating the effectiveness of tympanoplasty and ossiculoplasty.
3. Radiographic imaging studies, in the form of mastoid radiograph or computed
tomography scanning, are considered ancillary diagnostic tools.
Grade B Recommendation
Mastoid radiographs are used to evaluate the degree of pneumatization particularly in
9
surgical ears. Previous studies showed high false negative rates and low sensitivity (54%)
when mastoid radiographs were correlated with intra-operative findings of cholesteatoma.
There is also a marked paucity of studies on the use of mastoid radiographs in our review of
literature.
High-resolution computed tomography (HRCT) of the temporal bone is not routinely
requested but may have a value in (1) children, (2) medically unfit patients, (3) only or better
hearing ear, (4) patients in whom the tympanic membrane cannot be adequately visualized,
(5) patients who have had previous mastoid surgery, and (6) patients with intra-temporal or
4, 5, 6 ,7
intracranial complications.
4. Culture and sensitivity of ear discharge is not part of the routine initial diagnostic
assessment.
Grade A Recommendation
3

In the prospective comparative study of Khanna et al of 110 patients with active CSOM, the
group with culture and sensitivity prior to antibiotic treatment (broad-spectrum antibiotic
drops) attained dry ears in 100%, while the group without culture and sensitivity had a cure
rate of 74%. Based on these findings, they concluded that there is no definite role of culture

and sensitivity in the initial management of all cases of CSOM. This is further supported by
local studies that show no significant change in the pathogenic organisms in patients with
CSOM within the last twenty years. Therefore, patients with CSOM should initially be
prescribed a broad-spectrum antibiotic. Only in cases with failure of initial therapy should
culture and sensitivity be done.

RECOMMENDATIONS ON THE TREATMENT OF CHRONIC SUPPURATIVE OTITIS MEDIA


1. Aural toilet is an essential part of the treatment of CSOM in all patients.
Grade A Recommendation
Ear cleansing, also known as aural toilet, consists of mechanically removing ear discharge
and other debris from the ear canal and middle ear by mopping with cotton pledgets, wicking
with gauze, flushing with sterile solution, or suctioning. This can be done with an oto2
microscope, or under direct vision with adequate illumination of the middle ear.
2

The meta-analysis by Acuin et al showed that aural toilet, especially when combined with
antibiotic treatment is more effective in drying up otorrhea and eradicating middle ear bacteria
than no treatment. There was no good evidence of benefit from simple ear cleansing. Thus,
the panel agreed that aural toilet should be part of the initial management of CSOM in order
(1) to clean the ear canal and middle ear cavity; (2) adequately visualize and assess the
middle ear; (3) to allow the topical antibiotic to reach the middle ear cavity; and (4) to provide
symptomatic relief for the patient.
2. Topical quinolones, specifically ofloxacin, are recommended for the initial management
of CSOM for a period of 10-14 days. For persistent otorrhea, antibiotic therapy for an
additional two weeks is recommended.
Grade A Recommendation
Treatment of CSOM with aural toilet and topical antibiotics, particularly quinolones, is
2
effective in resolving otorrhea and eradicating bacteria from the middle ear. Acuin et al , in a
systematic review of five trials, reported that topical quinolones are more effective than non1
quinolones. Abes et al , concluded in their meta-analysis that 0.3% ofloxacin otic solution is
better than other antibiotic otic drops and oral antibiotics in terms of overall cure rate and
resolution of secondary outcome parameters. Thus, the topical ofloxacin given for 10-14 days
is highly recommended.
If there is insufficient symptomatic improvement or treatment failure, topical quinolones can
7
be applied for two more weeks, increasing clinical efficacy without causing safety problems.
3. Systemic antibiotics may be given for CSOM with associated bacterial upper repiratory
infections and complications.
Grade C Recommendation
One systematic review found that systemic antibiotics were significantly less effective than
2
topical antibiotics in reducing otoscopic features of chronic suppurative otitis media. Thus,
topical antibiotics remain to be the mainstay of treatment in CSOM. However, systemic
anitibotics may still be given to CSOM patients with associated bacterial upper respiratory
tract infections and complications.
4. Surgery must be performed on all cases of CSOM with suppurative complications.
Grade C Recommendation
Panel members agreed that the presence of intracranial and extracranial complications in
patients with CSOM is an absolute indication for mastoidectomy based on pathophysiologic

understanding of the disease and numerous case series. These complications include brain
abscess, meningitis, otitic hydrocephalus, lateral sinus thrombophlebitis, facial nerve
paralysis, labyrinthitis, and subperiosteal abscesses.
5. Surgery may be performed for those who fail to respond to adequate medical treatment.
Grade C Recommendation
There are no randomized clinical trials to date comparing medical treatment and
mastoidectomy in those patients in whom either procedure is a valid alternative. However,
case series describing the intra-operative findings of medically intractable cases have been
9
published. The indications for abandoning medical therapy are currently unclear; thus, the
panel saw no justification in making definite recommendations for the performance of either
procedure.

REFERENCES
1. Abes G, Espallardo N, Tong M, Subramaniam KN, Hermani B, Lasiminigrum L, Anggraeni R. A
Systematic Review Of The Effectiveness of Ofloxacin Otic Solution For The Treatment Of Suppurative Otitis
Media. J ORL & Health Specialties; Mar-Apr 2003.
2. Acuin J, Smith A, Mackenzie I. Interventions For Chronic Suppurative Otitis Media. Cochrane Database
Syst Rev. 2000; (2): CD000473.
3. Khanna, V., Chander J. Nagarkar NM, Dass A. Clinicomicrobiologic evaluation of active tubotympanic
type of chronic suppurative otitis media.
J. Otolaryngol. 2000 June; 29(3):148-53.
4. Leighton SE, Robson AK, Anslov P., Melford CA, The Role of CT Imaging in the Management of CSOM.
Clin. Otolaryngol. 1993 Feb; 18(1):23-9.
5. O Reilly BJ, et al. The Value of CT Scanning in Chronic Suppurative Otitis Media. J. Laryngol. Otol.
1991 Dec; 105(12):990-4.
6. Ramsey AM. Diagnosis and Treatment of the Child with a Draining Ear J. Pediatr. Health Care. 2002
Jul-Aug; 16(4) :161-9. (abstract)
7. Suzuki K, Nishimura T, Baba S, Yanagita N, Ishigami H. Topical Ofloxacin For Chronic Suppurative Otitis
Media And Acute Exacerbation Of Chronic Otitis Media: Optimum Duration Of Treatment. Otol Neurotol.
2003 May; 24(3): 447-52.
8. 2002 Annual Report, Out-patient Department, Philippine General Hospital.
9. Clinical Practice Guidelines 1997, PSO-HNS.

Persistent / Recurrent
EAR DISCHARGE
> 3 mos in an adult

OTOSCOPY
and other relevant ORL exams
Aural Toilet

Appropriate
Management

TM Perforation?

N
DIAGNOSIS OF CHRONIC
SUPPURATIVE OTITIS MEDIA
PTA-ST

Y
With Cholesteatoma and/or
Complications?

Appropriate
Management

N
Consider common pathogens e.g.
Pseudomonas, Staphylococcus aureus, Proteus mirabilis
TOPICAL OFLOXACIN x 10-14 days

Resolution of
Discharge?

OBSERVE

N
Continue TOPICAL OFLOXACIN x 2 wks

Resolution of
Discharge?

Y
OBSERVE

N
Consider other microbial pathogens
GS/CS, AFB, Fungal Studies

APPROPRIATE MANAGEMENT

N
Resolution of
Discharge?

OBSERVE

UP-PGH DEPARTMENTOF OTORHINOLARYNGOLOGY CLINICAL PRACTICE GUIDELINES


MEDICAL MANAGEMENT OF NASAL POLYPS IN ADULTS
SCOPE OF THE PRACTICE GUIDELINE
This clinical practice guideline is for use by the Department of Otorhinolaryngology of the College
of Medicine - Philippine General Hospital, University of the Philippines Manila. It covers the
diagnosis and medical treatment of nasal polyps in adults.
OBJECTIVES
The objectives of the guideline are (1) to evaluate current diagnostic techniques; and (2) to
present steroid treatment options.
LITERATURE SEARCH
This guideline is based on the 1998 Clinical Practice Guidelines Consensus Report of the
Philippine Society of Otorhinolaryngology- Head and Neck Surgery and revised according to
evidence. The Medline and PubMed were searched for literature using the following keywords
nasal polyposis, treatment, steroids, nasal spray. The search was limited to articles involving
humans and published in English. It yielded 21articles. Relevant full text articles were obtained
and assessed as follows:
Meta-analysis
Randomized controlled trial
Non-randomized controlled study
Descriptive study
Committee report

0
4
2
4
4

DEFINITION
Nasal polyp is a smooth, gelatinous, semi-translucent and pale white mass arising from the
mucosa surrounding the ostiomeatal complex. This was adapted from the 1998 PSO-HNS
consensus report on nasal polyps.
PREVALENCE
27,31
Nasal polyps occur in less than 5% of the general population.
It has also been estimated that
31
it is the diagnosis made in 1 out of 20 referrals to otolaryngologists.
In the PGH Department of ORL-Outpatient Clinic, the prevalence of diagnosed cases with nasal
polyps for 2002 is approximately 2.1% (Unpublished PGH-OPD Annual Report, 2002).
One percent to 5% of asthmatics and allergic rhinitis sufferers have nasal polyps. It is more
common in the older age group (12.4% in those above 40 years old and 3.15% in those below 40
years old.) Among children, it is even lower at 0.1%. There is no sex predilection. Nasal polyps
1
are often associated with other conditions .

RECOMMENDATIONS ON THE DIAGNOSIS OF NASAL POLYPS


1. Patients with nasal polyps present with common and less common signs and
symptoms. Some patients may be asymptomatic.
Grade C Recommendation
The following signs and symptoms are found among patients with nasal polyps
COMMON
Nasal obstruction
Rhinorrhea
Smell disturbances
Sneezing
Headache / facial pain

30, 17

LESS COMMON
Epistaxis
Cough
Hyponasal speech
Mouth breathing
Halitosis

2. Anterior and posterior rhinoscopy should be done to visualize the nasal polyps.
Grade C Recommendation
Nasal polyps and normal nasal turbinate can be differentiated as shown below:

Location
Moves on probing
Pain on probing
Shrinks with
decongestion
Bleeds with manipulation

NASAL POLYP
Usually at the osteomeatal
area
Yes
No
No

NASAL TURBINATE
Along entire lateral nasal wall

Yes / No

Yes

No
Yes
Yes

A nasal polyp and polypoid nasal mucosa may be difficult to differentiate clinically but a
peduncle seen on rhinoscopy would indicate a polyp. Massive nasal polyps may produce
nasal deformity.
3. Endoscopy can detect small polyps, which may not be seen on anterior rhinoscopy.
Grade C Recommendation
It can also assess the extent of the disease posterior and superiorly in Grade 1 and 2 nasal
polyps.
4. The classification of nasal polyps, based on size and extent, is used as a guide in the
management.
Grade C Recommendation
The endoscopic grading proposed by Mackay and Lund was adopted by the panel.
Grade 0
Grade I (mild)
Grade 2 (moderate)
Grade 3 (severe)

27, 28

absence of polyps
small polyps not reaching the lower edge of the middle
turbinate
medium-sized polyps extending between the upper and
lower edges of the inferior turbinate
large polyps extending below the lower edge of the inferior
turbinate

5. Plain sinus x-rays are of limited value in the determination of the actual extent of the
nasal polyposis.
Grade C Recommendation
Plain sinus x-rays may be helpful to detect the presence of chronic sinusitis and to
demonstrate bone erosion in massive polyposis. Bone erosions may indicate malignancy or
Woakes syndrome (aggressive recurrent sinonasal polyposis, erosion of ethmoid bones and
31
other sinuses, facial malformation).
6. The use of computed tomography of the paranasal sinuses is highly recommended for
medical treatment failures, complications of associated sinus disease and candidates
for surgery.
Grade C Recommendation
The recommended cuts for the CT scan are (1) screening CT scan and (2) coronal and axial
cuts for cases of recurrent nasal polyps.
RECOMMENDATIONS ON THE MEDICAL MANAGEMENT OF NASAL POLYPS
1. The management of Grade 1 and 2 nasal polyps is primarily medical.
Grade A Recommendation
The goals of medical management of nasal polyps are (1) to eliminate rhinitis symptoms, (2)
to restore the nasal airway, (3) to completely remove or reduce the size of nasal polyps, (4) to
31
improve the sense of smell, and (5) to prevent recurrence in post-operative patients.
Symptomatic relief of the patient is of utmost priority. After adequate medical treatment, a
patient who is symptom-free without an increase in the size of the polyp can be observed.
Concurrent disease (e.g. sinusitis, asthma, allergic rhinitis) should be addressed
concomitantly.
The concept of medical polypectomy with increased reliance on steroids (over surgery) has
to be adapted to the patient population. Financial capability is a primary concern for PGH
patients and a senior consultant expressed that prolonged costly topical steroid treatment
requiring regular follow-up may be deemed expensive and difficult along with deterioration
of skills in polyp and nasal surgery.
2. Grade 1 nasal polyps are managed with intranasal corticosteroid for 4 to 6 weeks. If
there is positive response to treatment, it is continued on a maintenance basis. If there
is no response to treatment, CT scan is recommended and the patient is re-evaluated.
Grade A Recommendation
Long-term topical steroids have shown significant results in at least 13 controlled trials.
Reduction of rhinitis symptoms, nasal polyp size and recurrence rate have been
demonstrated. Nasal breathing also improved. There is negligible effect on the sense of
31
smell. The following topical steroid preparations may be used:
26, 31
Budesonide aqueous or powder 400-800 ug/day
19, 27, 29
Fluticasone proprionate aqueous 400-800 ug/day
Mometasone 100 ug/day
The advantage of topical steroids is that they can be administered for long periods of time
without major side effects. The disadvantages of topical steroids are unequal distribution in the
nasal mucosa due to infection or large polyps, and insufficient delivery due to structural
abnormalities.
2. Grade 2 nasal polyps are managed with short-term systemic steroid and intranasal
steroid. They may be given concurrently or sequentially.

10

There are no studies yet showing the advantage of concurrent versus sequential steroid
therapy.
3.1 Concurrent treatment with short-term systemic steroids and intranasal steroids
Grade B Recommendation
5

Dual steroid therapy (topical and oral) based on the study by Bonfils showed that a
combined protocol gives better results than intranasal steroid therapy alone. Short-term
treatment courses of systemic steroid combined with long-term steroid intranasal spray
led to satisfactory results in 85% of the patients, and the mean clinical severity index was
5
reduced by 77.7% . A combined short-term steroid therapy is highly effective in chronic
7
polypoid rhinosinusitis.
3.2 Sequential treatment short-term systemic steroids followed by intranasal steroids
Grade C Recommendation
32

Slavin asserted that the reasonable approach to nasal polyposis should be based on
the oral prednisolone administration over a 10- to 14-day period followed by a course of
intranasal spray of either beclomethasone or flunisolide.
Short-term oral steroids have an effect on all types of symptoms and pathology, including the
3
sense of smell. Oral steroids recommended are the following:
27
Dexamethasone 12 mg to 3 mg within 9 days
31
Methylprednisolone 64 mg to 10 mg within 10 days
32
5
Prednisone 1 mg/kg for 10 days or 1mg/kg for 5 days
The advantages of oral steroids include (1) equal distribution; (2) more dramatic decrease in
26
the size of polyps ; and (3) significant early relief of symptoms.The disadvantage of oral
steroids is the occurrence of many major side effects. Presence of osteoporosis,
gastrointestinal disorders, severe hypertension, diabetes, herpetic keratosis and tuberculosis
contraindicate the use of oral steroids.
4. There is divergence in the management of Grade 3 polyps. Steroid treatment is usually
given initially. It is also where the surgical option is traditionally given the primacy.
Grade C Recommendation
In grade 3 polyps, many clinicians would commence with systemic corticosteroids and
28,30
continue with intranasal corticosteroids to maintain improvement.
Research will be
undertaken in the department to ascertain its cost-effectiveness for PGH patients. However,
it is recommended if patients cannot be cleared for surgery.
3. Response to medical treatment is graded accordingly:
0 no response
1 equivocal
2 significant improvement
Grade C Recommendation
No improvement of symptoms after 2 to 3 months of treatment and increase in the size of
polyps despite adequate medical treatment are considered treatment failures.
4. Topical steroid given after polypectomy reduces the number of recurrences.
Grade B Recommendation
18
Fluticasone and budesonide used for 6 to 12 months decreased the recurrence rate . These
medications are especially valuable in patients who have previously been subjected to
31
frequent polypectomies.

11

5. Adjunctive treatment is given depending on the patients concomitant problems.


Grade C Recommendation
Adjunctive treatment include the following:
1. Nasal douche to clean out discharge prior to application of intranasal steroids
2. Nasal decongestants for priming
3. Antibiotics to treat rhinosinusitis
4. Antihistamines to treat allergic rhinitis
5. Proton pump inhibitors (PPI) and H2-blockers prophylaxis for steroid-induced
gastritis
6. Office polypectomy

REFERENCES
1.
2.
3.
4.

5.
6.
7.

8.

9.
10.

11.

12.
13.
14.
15.
16.
17.

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Batsakis J. Pathology Consultation: Stromal Cells Atypia in Sinonasal Polyposis. Annals
of Otology Rhinology and Laryngology. 1986. 95:321-322.
Berg.O. Origin of the Choanal Polyp. Archives of Otolaryngology and Head Neck
Surgery. 1988; 114:1270-1271.
Biewenga J/ Albumin and immunoglobulin level in nasal secrections of patients with
nasal polyps treated with endoscopic sinus surgery and topical corticosteroids.
Journal of Allergy and Clinical Immunology. 1995; 96: 334-340.
Bonfils P, Nores J, Halimi P, Avan P. Corticosteroid Treatment in Nasal Polyposis
with a Three-Year Follow-up Period. Laryngoscope. April 2003; 113:683-687.
Coste A, et al. Increased epithelial cell proliferation in nasal polyps. Archives of
Otolaryngology and Head Neck Surgery. 1996; 122:432-436.
Damm, M., Jungehulsing, M., Eckel, H., Schmidt, M., Theissen, P. Effects of systemic
steroid treatment in chronic polypoid rhinosinusitis evaluated with magnetic
resonance imaging. Otolaryngology-Head and Neck Surgery. April 1999.pp 517-523
De la Cruz-Mera A, et al. Premalignant changes in nasal and sinus polyps: a
retrospective 10 year study (1976-1988). The Journal of Laryngology and Otology.
1990; 104: 210-212.
Dowell M, Pahor A. Nasal polypectomy: should antrral washout be a routine? The
Journal of Laryngology and Otology. 1992;106:695-696.
Drake-Lee A, et al. The effects of different fixation on the distribution and numbers of
mast cell in patients with nasal polyps. The Journal of Laryngology and Otology.
1988; 102:1099-1101.
Drake-Lee A, McLaughlan P. The Release of histamine from nasal polyp tissue and
peripheral blood when challenged with antihuman IgE, house dust mite extract and
mixed grass pollen extract and compared with positive skin tests. The Journal of
Laryngology and Otology. 1988; 102:886-889.
Drake-Lee A. Nasal polyps in identical twins. The Journal of Laryngology and Otology.
1992; 106:1084-1085.
Dunnete S, et al. Microbiologic analysis of nasal polyp tissue. Journal of Allergy and
Clinical Immunology. 1986: 78: 102-108.
El-Guindy A, Mousour MH. The role of transcanine surgery in antrochoanal polyp. The
Journal of Laryngology and Otology. 108: 1055-1057.
Gilbert Jg. Aaantroscopy in maxillary sinus disease associated with nasal polyposis.
The Journal of Laryngology and Otology 1989. 103:861-863.
Hasegawa M, Nasu M, Ohki M, Sugiuchi Y, Watanabe I. Malignant transformation of
Nasal polyp. Arch Otolaryngol Head Neck Surg. 1988;114:336-337.
Holmberg K, Karlsson G. Nasal Polyps: medical or surgical management? Clinical and
Experimental Allergy. 1996; 26(3):23-30.

12

18.

19.

20.
21.

22.
23.

24.

25.

26.

27.
28.

29.
30.

31.
32.

Holmberg K, Juliusson S, Balder B, Smith D, Richard D, Karlsson G. Fluticasone


propionate aqueous nasal spray in the treatment of nasal Polyposis. Annals of
Allergy, Asthma and Immunology. 1997; 78:270-6.
Jacobs R, Freda A, Culver W. Primary nasal Polyposis. Annals of Allergy. 1983;51:500505.
Jamal A, Maran A. Atopy and nasal Polyposis. The Journal of Laryngology and Otology.
1987; 101:355-358.
Jang Y, et al. Immunohistochemical characteristics of cultured nasal polyp epithelial
cells: expression of Cytokeratin, vimentin and proliferating cell nuclear antigen.
Journal of Rhinology. 1996; 3(2): 151-156.
Jin H. Angiomatous nasal polyp presenting recurrent epistaxis. Journal of Rhinology.
1996; 3(2) 174-176.
Ki Hwan Hong, Sam Hyun Kwon, Sang Sool Jung. The assessment of Nasality with
nasometer and sound spectography in patients with nasal Polyposis.
Otolaryngology- Head and Neck Surgery. 1997; 117:4
Kim Y, Denburg Ja. Stem cell factor in nasal polyposis: increased expression by
structural cells is suppressed by topical corticosteroids. Journal of Rhinology. 1996;
3(2) 157-165.
Kingdom T. Clinical characteristics and genotype analysis of patients with cystic fibrosis
and nasal polyposis requiring surgery. Archives of Otorlayngology and Head Neck
surgery. 1996; 122: 1209-1213.
Lildholdt T, Rundcrantz H, Bende M, Larsen K. Glucocorticoid Treatment for Nasal
Polyps: the use of topical budesonide powder, intramuscular betamethanosone, and
surgical treatment. Arch Otolaryngol Head Neck Surg. 1997; 123: 595-600.
Lund V. Diagnosis and treatment of nasal polyps. British Medical Journal. 1995; 311:
1411-1414.
Mackay IS; Lund VJ. Imaging and Staging. In: Mygind N, Lindholdt, Y. ed. Nasal
Polyposis: An Inflammatory Disease and its Treatment. Copenhage: Munksgaard,
1997: 137-144.
Mostafa, B. Fluticasone Proprionate is associated with severe infection after endoscopic
polypectomy. Arch Otolaryngol Head Neck Surg. 1996; 122:729-731.
Naclerio R, MacKay I. Guidelines for the Management of Nasal Polyps. In: Nasal
Polyposis: An Inflammatory Disease and Its Treatment. (Eds. Mygind M, LildholtT).
Munksgaard, Copenhagen, pp 177-180, 1997.
PSO-HNS consensus report on Nasal Polyps, 1998
Slavin, Raymond G. Medical Management of Nasal polyps and Sinusitis. Journal of
Allergy and Clinical Immunology

13

ALGORITHM FOR THE MEDICAL MANAGEMENT OF NASAL POLYPOSIS


Medical Management of Grade 2 polyps

History and Physical Exam


Diagnostics (Anterior and
Posterior
Rhinoscopy/Endoscopy

Grading of
polyps

Grade 1

SEQUENTIAL
Systemic corticosteroids
1-2 weeks

Followed 4-6 weeks


nasal steroid spray

Grade 2 & 3

Response grading
0 No response
1 Equivocal
2 Significant
improvement

Management of
unresponsive
Grade 1 polyp

Intranasal Steroid Spray 4-6 weeks

OR

CONCURRENT
Systemic corticosteroids
1-2 weeks + Intranasal
steroids x 4-6 weeks

CT scan highly
recommended &
re-evaluation &
pre-op preparation

Response?
0,1,2

Y(2)
Y(1)

Management of
Grade 3 polyps

Response?
(Grade 1 or
2 response)

Go to Mgt
of Grade 2
polyps

Y
Continue use of topical intranasal
steroids; Observe every 2-3 months

Continue
intranasal
steroids, may
give systemic
steroids in 3-4
cycles per year
(at least 3 mointerval per
cycle

CT scan highly
recommended &
re-evaluation &
pre-op preparation

Ffup q1 mo.
for 6 mos;
encourage use
of intranasal
steroids; ffup
regularly q2-3
mos thereafter

Consider Surgery
(ESS/PEA)

Systemic corticosteroids for 1-2


weeks + nasal steroid spray

Response?

N
NOTE: FOR RECURRENT NASAL POLYPS

Grade 1 proceed to management of


grade 1 polyps
Grade 2-3 proceed to management of
grade 2&3 polyps (may repeat for 3-4
cycles per year)

Y
Continue topical intranasal steroids; Follow
up every month for 6 months; Follow up
regularly every 2-3 months thereafter

14

UP-PGH DEPARTMENT OF OTORHINOLARYNGOLOGY CLINICAL PRACTICE GUIDELINES


ACUTE AND CHRONIC TONSILLITIS IN CHILDREN
SCOPE OF THE PRACTICE GUIDELINE
This clinical practice guideline is for use by the Department of Otorhinolaryngology of the College
of Medicine - Philippine General Hospital, University of the Philippines Manila. It covers the
diagnosis and management of tonsillitis in otherwise healthy children, older than 1 year of age.
OBJECTIVES
The objectives of the guideline are: (1) to heighten the recognition of tonsillitis, particularly due to
Group A Beta-hemolytic Streptococcus, to avoid delay and serious sequelae; (2) to evaluate
current diagnostic techniques; and (3) to describe treatment options.
LITERATURE SEARCH
This guideline is based on the 1997 Clinical Practice Guidelines of the Philippine Society of
Otorhinolaryngology Head and Neck Surgery and revised according to new evidence. The
National Library of Medicines PubMed database was searched for literature using the keyword
tonsillitis. The search was limited to articles involving humans and those published in English in
the last ten years. It yielded 919 articles, the titles of which were carefully screened for possible
relevance to the guideline. Thirty-seven (37) abstracts were chosen and results were
synthesized. Full text articles were obtained when possible. In addition, several current guidelines
on sore throat / pharyngitis and indications for tonsillectomy were included after evaluation of the
references on which they were based. The chosen articles were divided as follows:
Meta-analysis
Randomized controlled trial
Non-randomized controlled study
Descriptive study
Committee report

6
8
3
15
5

DEFINITION
Acute tonsillitis is defined as the presence of erythematous and/or exudative tonsils with any
one of the following symptoms: sore throat, dysphagia, odynophagia, fever and accompanying
8
tender enlarged cervical lymph nodes.
Chronic tonsillitis is defined as tonsillar inflammation resulting from recurrent clinically
8
documented acute attacks of tonsillitis occurring at least 5 times per year.
These definitions were adapted from the 1997 CPG of the PSO-HNS. However, the frequency
was increased from 3-4 times a year to at least 5 times a year based on a study by
25
Paradise which indicated that present guidelines for tonsillectomy are not sufficiently stringent.
These patients are usually candidates for surgery, but the modest benefit offered by tonsillectomy
25
to these moderately affected patients is outweighed by the risks and cost of the operation.

PREVALENCE
The major issue in most cases of acute tonsillitis is whether it is associated with Group A Betahemolytic Streptococci (GABHS) or to other self-limited etiologies of sore throat, such as a viral
infection. Only about 20% of cases of pharyngitis and tonsillitis are caused by GABHS, but its
associated risks of subsequent acute rheumatic fever and/or acute glomerulonephritis remain a
24
cause for concern. The incidence of rheumatic fever remains high at 100-200 cases per
100,000 children in developing countries in contrast with the 0.5 cases per 100,000 children in
industrialized countries.
The risk of developing rheumatic fever following untreated
3
tonsillopharyngitis is 1% in the civilian population.

15

In 2002, there were 142 cases of acute and chronic tonsillitis seen at the ORL outpatient clinic of
the Philippine General Hospital, with 94 tonsillectomies performed during the same time period.
At the Department of Pediatrics, there were 178 patients with rheumatic fever and 608 patients
1
with rheumatic heart disease for the year 2002.

RECOMMENDATIONS ON THE DIAGNOSIS OF ACUTE AND CHRONIC TONSILLITIS


1. The diagnosis of acute tonsillitis may be made clinically.
Grade B Recommendation
The symptoms include sore throat (usually lasting more than three days), dysphagia,
odynophagia, anorexia, lethargy and systemic illness. Abnormal physical signs are
erythematous tonsils or pharynx, purulent exudates on tonsils, fever and tender cervical
14, 15, 20, 21
lymphadenopathy.
History must ensure whether the above symptom complex occurs at least five times in a
year to determine whether the patient has acute or chronic tonsillitis.
2. The diagnosis of GABHS tonsillitis should be suspected on clinical and
epidemiological grounds.
Grade B Recommendation
The signs and symptoms of both bacterial and viral infection overlap broadly, but the
diagnosis of GABHS infection should be suspected based on epidemiologic and clinical
3, 21
characteristics.
Epidemiological features suggestive of GABHS are (1) age 5-15
years; (2) recent close contact with a documented case; and (3) known high prevalence
of GABHS in the community. Pertinent clinical findings include sudden onset sore throat,
odynophagia, dysphagia, fever, vomiting, pharyngeal exudates, scarlatiniform rash and
tender anterior cervical lymphadenopathy. Watery eyes, rhinitis, cough and hoarseness
are negative predictors.
In the United States, where rheumatic fever and rheumatic heart disease are still
reported, clinical diagnosis is still valuable. The Scottish Intercollegiate Guideline Network
does not find the diagnosis of GABHS based on clinical grounds valid or useful, but this
20
may be due to the rarity of the complications.
3. Laboratory testing is recommended for patients who are suspected to have
GABHS infection based on clinical and epidemiological grounds. Positive throat
cultures and rapid antigen tests will confirm GABHS infection.
Grade C Recommendation
There is controversy regarding the use of throat culture and rapid antigen tests in the
20
diagnosis of GABHS infection. Studies from the United Kingdom show that these tests
are neither sensitive nor specific for serologically confirmed infection. These
20
considerably increase costs and alter few management decisions. On the other hand,
21
studies from the United States demonstrate that throat culture is still the gold standard
for confirmation of the diagnosis of GABHS pharyngitis, with a sensitivity of 90% to 95%.
Rapid antigen tests have more then 95% specificity, but only 80% to 90% sensitivity
21
when compared to culture. However, the value of early diagnosis in the minority of
cases when streptococcus is present should be weighed against the higher cost incurred
in testing the majority of cases seen. Selective use of diagnostic studies is suggested.

16

RECOMMENDATIONS ON THE MANAGEMENT OF ACUTE AND CHRONIC TONSILLITIS


1. Antimicrobial therapy is reserved for symptomatic patients with positive throat
cultures or positive rapid antigen testing.
Grade B Recommendation
The benefits from antibiotic therapy include early resolution of symptoms (if due to
bacterial pathogens) and prevention of cross-infection, rheumatic fever and
glomerulonephritis. However, not all cases of tonsillitis will require the use of antibiotics,
as in self-limiting viral infections. Antibiotics must be used rationally to preserve the
normal flora in the aerodigestive tract, prevent development of resistance in pathogenic
2, 21
organisms and decrease treatment costs.
Several strategies may be employed which strike a balance between overuse and
unreasonable withholding of antibiotics. One may opt not to treat patients unlikely to have
GABHS pharyngitis and treat only those strongly suspected of having GABHS wherein
the diagnosis must be confirmed with laboratory tests. Antibiotics may be started while
awaiting results, but discontinued if results are negative.
2. Penicillin is the drug of choice for compliant patients with GABHS infection.
Grade A Recommendation
Patients with acute GABHS tonsillitis should receive therapy with an antimicrobial agent
in a dosage and for a duration that is likely to eradicate the organism from the pharynx.
Penicillin has a narrow spectrum of activity, which includes GABHS, has infrequent
21
adverse reactions and is not costly.
Its bacteriological eradication rate ranges from
23, 36
84% to 92%, with a clinical cure rate of 96%,
despite being given two to four times a
19
day for ten days.
Alternative antibiotics with less side effects, infrequent dosing,
palatable, and efficacious with short-course therapy lead to better outcomes due to good
compliance. Amoxicillin has been shown to be as effective as penicillin, with the
21
advantage of better palatability.
Its bacteriological eradication rate is 86%, with a
16
clinical cure of 97%. Cefuroxime, azithromycin and clarithromycin has been shown to
have bacterial (86%, 98%, 88%) and clinical (95%, unknown, 98%) cure rates
16, 23, 31, 36
comparable with penicillin.
Erythromycin, which has been the drug of choice for
5, 21
patients with penicillin allergy, has a lower bacterial eradication rate of 74% .
3. Supportive therapy is recommended for all patients with tonsillitis.
Grade C Recommendation
Adequate supportive care should be part of the routine management of acute tonsillitis.
For those with viral infection, this may be all that is necessary. These include sufficient
fluid intake, bed rest, warm saline gargle and oral hygiene. The use of antipyretics for
fever as well as analgesics, oral anesthetics and antiseptics for patients with marked
throat pain may be recommended.
These are recommendations from the 1997 PSO-HNS CPG, based on strong panel
consensus and expert opinion. They are further supported by similar recommendations
8, 20
from other guidelines .

17

4. The absolute indications for tonsillectomy are the following:


4.1 Adenotonsillar hyperplasia with obstructive sleep apnea, failure to thrive or
abnormal dentofacial growth
4.2 Suspicion of malignancy
4.3 Hemorrhagic tonsils
Grade C Recommendation
5. The relative indications for tonsillectomy are the following:
5.1 Adenotonsillar hyperplasia with upper airway obstruction, dysphagia, speech
impairment or halitosis
5.2 Recurrent or chronic tonsillitis
5.3 Peritonsillar abscess
5.4 Streptococcal carriage
Grade C Recommendation
6. Patients with recurrent or chronic tonsillitis who meet all of the following criteria
are recommended for surgery:
6.1 Sore throats are due to tonsillitis.
6.2 Five or more episodes of tonsillitis per year
6.3 Symptoms for at least a year
6.4 Episodes of sore throat are disabling and prevent normal functioning.
Grade A Recommendation
The literature on surgery for tonsillitis is scanty; and results of the better-quality studies
contradict each other. Most articles refer to a pediatric population and confuse the issue
with the addition of adenoidectomy. Present guidelines from the American Academy of
Otolaryngology require a minimum of 3 episodes of tonsillitis in a year before surgery is
contemplated. However, Paradise found that this criterion is not stringent enough and
that the modest benefit offered by tonsillectomy to these moderately affected patients are
25
outweighed by the risks and cost of the operation. The small amount of literature about
tonsillitis in adults suggests that tonsillectomy may be beneficial in terms of decreasing
time off from work and minimizing costs from repeated consults and use of antibiotics.

18

REFERENCES
1. Annual Report for Rheumatic Fever/Rheumatic Heart Disease, Section of Pediatric Cardiology,
Department of Pediatrics, Philippine General Hospital.
2. Abdul-Baqi et al. Effectiveness of Treatment of Tonsillopharyngitis: Comparative Study.
Journal of Laryngology and Otology 2002 Nov: 116 (11): 917-9.
3. Bassili A. et al Identification of Clinical Criteria for Group A Beta- Hemolytic Streptococcal
pharyngitis in children living in a Rheumatic Fever Area. Journal of Tropical Pediatics
2002 Oct; 48 (5) ; 285-93.
4. Brook I, Shah K. Bacteriology of Adenoids and Tonsils in Children with recurrent
Adenotonsillitis. Ann Otol Rhinol Laryngol. 2001 Sep; 110(9); 844-8.
5. Brook I et al. Open label, Parallel-group, Multicenter, Randomized Study of Cefrozil
versus erythromycin in Children with Group A Streptococcal
Pharyngitis/Tonsillitis. Clin Ther 2001 Nov; 23(11); 1889-900
6. Burton MJ et al. Tonsillectomy versus Non-surgical Treatment for Chronic/Recurrent
Acute Tonsillitis. Cochrane Database Syst Rev. 200;(2): CD001802
7. Cohen R et al. Comparison of Two Dosages of Azithromycin for 3 days versus Penicillin
V for 10 days in Acute Group A Streptococcal Tonsillopharyngitis
8. Clinical Practice Guidelines on Acute and Chronic Tonsillitis, Philippine Society of
Otolaryngology Head and Neck Surgery, 1997.
9. Darrow DH, Siemens C. Indication for Tonsillectomy and Adenoidectomy.
Laryngoscope 2002 Aug; 112 (8 Pt 2) : 6-10
10. Deutsch ES. Tonsillectomy and Adenoidectomy: Changing indications. Ped Clin of North Am
1996 Dec; 43 (6)
11. Discolo CM et al Infective Indications for Tonsillectomy. Pediatr Clin North AM. 2003
Apr 50(2); 445-59
12. Donner Banzhoff et al Clinical Findings in Patients Presenting with sore throat. A Study
in Inter-observer Reliability. Fam Pract. 2002 Oct; 19(5); 466-8
13. Gaffney RJ et al Bacteriology of tonsil and adenoid and sampling techniques of adenoidal
bacteriology. Respir Med 1993 May; 87 (4); 303-9
14. Hossain P et al Clinical Features of District Hospital Paediatric Patients with Pharyngeal
Group A Streptococcal. Scand J Infect Dis 2003;35(1); 77-9
15. Johnson BC Alvi A Cost- Effective Work-up for Tonsillitis. Testing, Treatment and
Potential Complication. Post-grad Med. 2003 Mar;113 (3); 115-8
16. Kearsley NL et al Comparison of clarithromycin Suspension and Amoxycillin Syrup for
the Treatment of Children with Pharyngitis and/or Tonsillitis. BR J Clin Pract
1997 Apr- May; 51 (3); 133-7
17. Kindo AJ et al Role of Surface swab, Core swab and Fine Needle Aspiration in isolating
the core bacteria in inflamed tonsils. Indian J Pathol Microbiol 2001 Jul;44(3);293-5
18. Kurien M et al Throat Swab in the Chronic Tonsillitis: How reliable and valid is it?.
Singapore Med J 200 Jul; 41 (7): 324-6
19. Lan AJ et al The impact of dosing frequency on the efficacy of 10-day Penicillin or
Amoxycillin therapy for Streptococcal tonsillopharyngitis; A Meta-analysis
Pediatrics 2000 Feb; 105 (2): E19
20. Management of Sore Throat and Indications for Tonsillectomy, Scottish Intercollegiate
Guidelines Network January 1999.
21. National Guideline Clearinghouse (NGC). Guideline Synthesis: Pharyngitis/Sore Throat. In:
National Guideline Clearinghouse [website]. Rockville (MD): 1999 Oct 6 (revised 2002
Aug 19).
22. Nerbrand C et al Are current rapid detection tests for Group A Streptococci sensitive
enough? Evaluation of 2 Commercial Kits. Scand j Infect Dis 2002; 34(11):797-9
23. O Doherty B Azithromycin versus Penicillin V in the treatment of Pediatrics patients
with Acute Streptococcal Pharyngitis/Tonsillitis Pediatrics Azithromycin Study
Group .Eur J Clin Microbiol Infect Dis 1996 Sep; 15(9); 718-24
24. Olivier C Rheumatic Fever. Is it still a problem? J Antimicrob Chemother 2000

19

Feb; 45 Suppl: 13-21


25. Paradise JL et al Tonsillectomy and adenoidectomy for recurrent throat infection in
moderately affected children. Pediatrics 2002 July; 110 (1): 7-15.
26. Paulussen C et al Adenoid & Tonsils, Indication for surgery and immunological
consequences of Surgery. Acta Otorhinolaryngol Belg 2000; 54(3) : 403-8
27. Pichichero ME Evaluating the needs, timing and best choice of antibiotics therapy of
Acute Otitis Media and Tonsillopharyngitis infections in children. Pediatr Infect
Dis J. 2000 Dec 19 (12 Suppl): S131-40
28. Pichichero ME et al. Recurrent Group A Streptococcal Tonsillopharyngitis Pediatr Infect
Dis J 1998 Sep; 17(9): 809-15
29. Pichichero ME: Sore throat after sore throat after sore throat. Are you asking the critical
question? Postgrad Med 1997 Jan; 101(1): 205-6
30. Prim et al Spontaneous Resolution of recurrent tonsillitis in Pediatric Patients on the
Surgical Waiting lists. Int. J Pediatr Otorhinolaryngol 2002 Aug 1;65 (1): 35-8
31. Quinn J et al Efficacy & Tolerability of 5-day once daily Telithromycin compared with
10-day twice daily clarithromycin for the treatment of Group A Beta- hemolytic
Streptococcal Tonsillitis/Pharyngitis a multicenter, randomized, double blind
parallel group study. Clin Ther 2003 Feb;25 (2): 422-43
32. Raut VV. Management of peritonsillitis/peritonsillar abscess. Rev Laryngol Otol Rhinol (Bord)
2000;121(2):107-10
33. Raut VV, Yung MW Peritonsillar Abscess: the rationale for interval tonsillectomy. Ear
Nose Throat J. 2000 Mar; 79(3) : 206-9
34. Robinson AC et al Throat Swab in chronic tonsillitis: a time-honoured practice best
forgotten Br J Clin Pract. 1997 Apr-May; 51(3): 138-9
35. Sun J et al Evaluation of the etiologic agents for acute suppurative tonsillitis in children.
Zhonghua Yi Xue Za Zhi (Taipei). 2002 May; 65(5): 212-7
36. Uysal S et al A comparison of the efficacy of cefuroxime axetil and intramuscular
benzathine penicillin for treating streptococcal tonsillopharyngitis Trop Paediatr
2000 Sep;20(3): 199-202
37. Woolford TJ et al Spontaneous resolution of tonsillitis in children on the waiting list for
tonsillectomy. Clin Otolaryngol. 2000 Oct; 25(5): 428-30.

20

Child with
signs and symptoms of
tonsillitis

5 or more
times a year?

No

No
Acute
Tonsillitis

Bacterial?

Supportive management

Yes
Yes

No

GABHS?
Chronic Tonsillitis

Appropriate antibiotics
Supportive management

Yes

Appropriate antibiotics
Supportive management
Consider tonsillectomy

Appropriate antibiotics
Supportive management

No
Resolution?

Yes
Consider Tonsillectomy

Throat
Swab

Confirms
GABHS?

No
Reassess

Yes
Revise antibiotics

Resolution?

No

Reassess

Yes
Consider Tonsillectomy

21

UP-PGH DEPARTMENT OF OTORHINOLARYNGOLOGY CLINICAL PRACTICE GUIDELINES


OBSTRUCTIVE SLEEP APNEA SYNDROME IN CHILDREN
SCOPE OF THE PRACTICE GUIDELINE
This clinical practice guideline is for use by the Department of Otorhinolaryngology of the College
of Medicine - Philippine General Hospital, University of the Philippines Manila. It covers the
diagnosis and management of obstructive sleep apnea syndrome in children. This guideline only
applies to children more than 1 year of age with obstructive symptoms attributable to
adenotonsillar hypertrophy and/or obesity. Children with neuromuscular, craniofacial, neurologic,
and other metabolic diseases that may contribute to ventilation problems during sleep are
specifically excluded from this guideline.
OBJECTIVES
The objectives of the guideline are (1) to enhance the ability to recognize OSAS; (2) to determine
the diagnostic procedures that may effectively diagnose OSAS using the least financial resources
possible; (3) to describe the ideal diagnostic modalities for pediatric OSAS; (4) to describe
management options in pediatric OSAS; and (5) to identify high-risk patients for post-operative
complications.
LITERATURE SEARCH
The guideline was based on data available from medical literature. A computerized search of the
National Library of Medicines PubMed database was performed using the key words sleep
apnea syndrome, sleep disordered breathing, apnea, tonsillectomy, adenoidectomy and
polysomnography. The search was limited to clinical trials, meta-analysis, practice guideline and
randomized control trial studies written in English on children (0-18 years). Editorials, letters and
reviews as well as animal studies were excluded. The search resulted in 733 articles. Those
related to the pediatric patient population with craniofacial anomalies, congenital conditions,
metabolic diseases and sudden infant death syndrome were eliminated. Ninety-five articles were
evaluated which yielded 28 studies. Abstracts were reviewed and full text articles obtained when
possible. The Clinical Practice Guideline: Diagnosis and Management of Childhood Obstructive
Sleep Apnea Syndrome (April 2002) by the American Academy of Pediatrics in particular was
reviewed and its references obtained.
DEFINITIONS
Obstructive sleep apnea syndrome (OSAS) is characterized by partial or complete pharyngeal
obstruction during sleep combined with daytime somnolence. This is better elaborated in the
following definition of the American Thoracic Society:
OSAS in children is a disorder of breathing during sleep characterized by prolonged
partial upper airway obstruction and/or intermittent complete obstruction (obstructive apnea) that
disrupt normal ventilation during sleep and normal sleep patterns. It is associated with symptoms
including habitual (nightly) snoring, sleep difficulties, and/or daytime neurobehavioral problems.
Primary snoring is defined as loud upper-airway breathing sounds in sleep, without episodes of
apnea or hypoventilation.
Sleep disordered breathing is a broader term that encompasses all breathing disorders during
sleep. These are obstructive, central and mixed sleep apnea, central hypoventilation syndrome,
breathing disorders due to craniofacial, metabolic and medical conditions,etc.
PREVALENCE
There are no studies to determine prevalence in the local setting. However, based on foreign
literature (Britain, Iceland and the United States) similar prevalence rates were reported at 2%. It
is commonly found in preschool-aged children aged 2 to 5 years, as this is the age when the
tonsils and adenoids are relatively large for the airway size. There is a second peak during middle
to late adolescence but is qualitatively similar to adult OSAS. It occurs equally in boys and girls.
Post-pubertal distribution likewise reflects the male preponderance of adult OSAS.

22

RECOMMENDATIONS ON THE DIAGNOSIS OF OBSTRUCTIVE SLEEP APNEA SYNDROME


A child is commonly referred for sleep evaluation because the parents are anxious. Common
complaints are persistent snoring, labored breathing and witnessed apnea.
1. Routine sleep history and physical examination should be obtained.
Grade B Recommendation
Whenever a child is referred for sleep apnea or snoring, the height and weight must be
recorded. A routine sleep history and physical examination should be developed. History
should include inquiries on the following:
1.1 Habitual snoring
1.2 Labored breathing during sleep
1.3 Observed apnea
1.4 Paradoxical chest / abdomen motion
1.5 Restless sleep
1.6 Diaphoresis, enuresis, retractions
1.7 Cyanosis
1.8 Excessive daytime sleepiness
1.9 Behavior and learning problems (including attention-deficit hyperactivity disorder)
Physical examination may not be productive but may include the following:
1.10 Adenotonsillar hypertrophy
1.11 Mouth breathing
1.12 Nasal obstruction
1.13 Adenoidal facies
1.14 Hyponasal speech
1.15 Pectus carinatum with flaring of lower ribs
1.16 Poor growth / failure to thrive OR obesity
It should be noted that clinical evaluation is not very effective in determining the presence of
OSAS. It is up to the clinician to determine if the problem should be pursued. If the history
and physical examination are not consistent with OSAS and the suspicion for disease is low,
the parents are reassured and the patient is followed up.
2. If the patient has signs of right-sided heart failure such as dyspnea and orthopnea, it
would be best that the patient be managed by a pediatric pulmonologist or a
cardiologist with a backgound in sleep medicine.
Grade C Recommendation
3. Witnessed apnea as seen by a laboratory technician or clinician is considered
acceptable evidence to proceed with treatment of OSAS according to the guidelines
published by the American Thoracic Society.
Grade C Recommendation
However, witnessed apnea as seen by the parents may be considered a positive finding. This
should manifest as cessation of breathing with continued effort (increased abdominal and
chest wall motion). If the parents are unsure if the child is breathing, they may be advised to
place a piece of thin tissue paper in front of the childs nose when an apneic event is
suspected. Ask them to count duration of the event. If the clinician doubts the report of the
parents, he/she may request for diagnostic tests.
4. Nocturnal polysomnography is the gold standard in the diagnosis of OSAS.
Grade B Recommendation

23

It can distinguish between OSAS and primary snoring provided that a criterion appropriate for
pediatric patients is used. It can determine severity of OSAS, degree of respiratory
compromise and sleep architecture. This is the only study where the grading of severity of
OSAS may be used. There has been some concern over the first-night effect of overnight
polysomnography wherein a single-nights study may not always provide accurate
information. However, it has been shown that the first-night effect is insignificant. In a study of
30 children with 2 overnight PSGs done between 7 to 27 days apart, all parameters
measured had no significant difference. No child changed diagnosis from primary snoring to
OSA or the other way around. Therefore, the result of a single technically correct PSG is an
adequate measure of OSAS.
Unfortunately, nocturnal polysomonography is time consuming and expensive. A number of
less costly tests may be used as screening tools. If positive, they are highly predictive of
OSAS. But when negative, they provide no diagnostic value. Nocturnal polysomnography
should, therefore be done in patients when the screening methods are equivocal or negative.
It should be the first line diagnostic modality for those patients who can afford it.
4.1 Audiotaping and videotaping. Results of 3 studies showed a sensitivity of 71% to 94%
and a specificity of 29% to 80%. Positive predictive values were 50% and 75% for
audiotaping and 83% for videotaping. Sounds of struggle during sleep were more
predictive than respiratory pauses. Negative predictive value was 73% to 88%. The
methods used for evaluating audio and video recordings were not standardized. Though
deficient in supporting data, these techniques, when highly suspicious for OSAS may be
used in deciding to proceed with treatment. During videotaping, if a suspected apneic
event occurs, the parent places a thin piece of tissue in front of the childs nose to
determine if there is airflow.
4.2 Overnight pulse oximetry. A positive predictive value (PPV) of 97% and a negative
predictive value (NPV) of 47% was shown in 1 study. This test is considered positive
when there is a cyclic desaturation pattern during sleep. Thus, results are only useful
when positive and may be used in deciding to proceed with treatment.
4.3 Nap polysomnography. This is done for 1 hour during the day. Children unable to sleep
are sedated with choral hydrate without adversely affecting the results. PPV was 77% to
100% and NPV was 17% to 49%. This test is only useful when positive but it tends to
underestimate severity of disease.
4.4 Unattended home polysomnography. This yielded similar results to laboratory studies but
was done using sophisticated equipment that is unavailable in the Philippines. Standard 6
to 8-channel home equipment will probably be technically difficult to maintain in children
in an unattended study and is, therefore, not recommended.
RECOMMENDATIONS ON THE MANAGEMENT OF OBSTRUCTIVE SLEEP APNEA
SYNDROME
1.

Parental reassurance and close patient


polysomnography result is negative.
Grade C Recommendation

follow-up

are

recommended

if

the

2. Tonsillectomy and adenoidectomy are recommended if (1) the polysomnography result


is positive; or (2) the screening tests are positive.
Grade A Recommendation
The most common cause of OSAS in children is still adenotonsillar hypertrophy.
Adenotonsillectomy is usually curative and has been shown to significantly improve quality of
life and learning capacity of patients. Polysomnographic resolution occurs in 75% to 100%

24

and is associated with resolution of symptoms. Results may be less satisfactory in obese
children.
3. All OSAS patients for surgery should be done on an in-patient basis with post-operative
overnight monitoring by pulse oximetry. Post-operative PICU admission is prudent in
cases where the risk factors are present.
Grade B Recommendation
The risk factors for post-operative complications in children with OSAS undergoing T&A are
the following: 1) age younger than 3 years, 2) severe OSAS on polysomnography, 3) cardiac
complications of OSAS (e.g. right ventricular hypertrophy), 4) failure to thrive, 5) obesity, 6)
recent respiratory infection, 7) prematurity, 8) craniofacial anomalies, and 9) neuromuscular
disorders.
4. All patients should have regular follow-up after treatment.
Grade C Recommendation
In other countries, frequency or follow-up is determined by OSAS severity as graded by
nocturnal polysomnography. However, this does not apply to this guideline due to the
acceptance of positive results from alternative screening tools. These do not quantify
respiratory events during sleep and no grade can be derived. The frequency of follow-up
should then be determined by the presence of symptoms. Children with continued symptoms
may need laboratory polysomnography.
5. Continuous Positive Airway Pressure (CPAP) may be used for some patients with
special situations.
Grade C Recommendation
CPAP may be used in patients with (1) minimal adenotonsillar tissue; (2) surgical
contraindications; or (3) persistent OSAS after tonsillectomy and adenoidectomy. This will
need to be used indefinitely and may result in midfacial hypoplasia. Small children and those
with learning disabilities may require behavioral techniques to improve acceptance. Another
option is the use of mandibular repositioning dental appliances.
6. Adjunctive treatment modalities should not delay initiation of more definitive
treatment.
Grade B Recommendation
The adjunctive treatments include: 1) weight loss for obese patients, 2) avoidance of
tobacco/cigarette smoke exposure, 3) avoidance of indoor pollutants, 4) environmental
allergen control in the home, 5) treatment of accompanying rhinitis, 6) avoidance of sleep
deprivation, and 7) avoidance of sedating medications.

REFERENCES
1.

2.

3.
4.

American Academy of Pediatrics, Section on Pediatric Pulmonology, Subcommittee on Obstructive


Sleep Apnea Syndrome. Clinical practice guideline: diagnosis and management of childhood
obstructive sleep apnea syndrome. Pediatrics. 2002;109(4):704-712.
Schechter MS, and the American Academy of Pediatrics, Section on Pediatric Pulmonology,
Subcommittee on Obstructive Sleep Apnea Syndrome. Technical Report: diagnosis and
management of childhood obstructive sleep apnea syndrome. Pediatrics. 2002;109(4).
American Thoracic Society. Standards and indications for cardiopulmonary sleep studies in
children. Am J Respir Crit Care Med. 1996;153:866-878.
American Sleep Disorders Association. International Classification of Sleep Disorders, Revised:
Diagnostic and Coding Manual. Rochester, MN: American Sleep Disorders Association; 2001.

25

5.
6.

7.
8.
9.
10.

11.
12.

13.

14.
15.
16.
17.
18.
19.
20.
21.

22.

23.

24.
25.
26.

27.
28.

Marcus C, State of the Art, sleep disordered breathing in children. Am J Respir Crit Care Med.
2001;164:16-30.
de Serres L, Derkay C, Sie K, Biavati M, Jones J, Tunkel D, Manning S, Inglis A, Haddad J,
Tampakopoulou D, Weinberg A. Impact of Adenotonsillectomy on the quality of life in children with
obstructive sleep disorders. Arch Otolaryngol Head Neck Surg. 2002;128:489-496.
Urschitz M, Wolff J, von Einem V, Urschitz-Duprat P, Schlaud M, Poets C. Reference values for
nocturnal home pulse oximetry during sleep in primary school children. Chest. 2003;123:96-101.
von Someren V, Burmester M, Alusi G, Lane R. Are sleep studies worth doing? Arch Dis Child.
2000;83:76-81.
Gozal D. Sleep-disordered breathing and school performance in children. Pediatrics.
1998;102:616-620.
Redline S, Tishler P, Schluchter M, Aylor J, Clark K, Graham G. Risk factors for sleep-disordered
breathing in children, associations with obesity, race, and respiratory problems. Am J Respir Crit
Care Med. 1999;159:1527-1532.
Marcus C, Mc Colley S, Carroll J, Loughlin G, Smith P, Schwartz A. Upper airway collapsibility in
children with obstructive sleep apnea syndrome. J Appl Physiol. 1994;77:918-924.
Brilouette R, Morielli A, Liemanis A, Waters K, Luciano R, Ducharme, F. Nocturnal pulse oximetry
as an abbreviated testing modality for pediatric obstructive sleep apnea. Pediatrics. 2000;105:405412.
Saeed M, Keens T, Stabile M, Bolokowicz J, Davidson Ward S. Should children with suspected
obstructive sleep apnea syndrome and normal nap sleep studies have overnight sleep studies?
Chest. 2000;118:360-365.
Li K, Riley R, Guilleminault C. An unreported risk in the use of home nasal continuous positive
airway pressure and home nasal ventilation in children. Chest. 2000;117:916-918.
Bower C, Gungor A. Pediatric obstructive sleep apnea syndrome. Otolaryngol Clinics of North Am.
2000;33:49-75.
Wiatrak BJ, Myer CM, Andrews TM. Complications of adenotonsillectomy in children under 3 years
of age. Am J Otolaryngol. 1991;12:170-172.
Marcus CL, Keens TG, Ward SL. Comparison of nap and overnight polysomnography in children.
Pediatr Pulmonol. 1992;13:16-21.
Marcus CL, Greene MG, Carrol JL. Blood pressure in children with obstructive sleep apnea. Am J
Respir Crit Care Med. 1998;157:1098-1103.
Wang RC, Elkins TP, Keech D, Wauquier A, Hubbard D. Accuracy of clinical evaluation in pediatric
obstructive sleep apnea. Otolaryngol Head Neck Surg. 1998;118:69-73.
Sivan Y, Kornecki A, Schonfeld T. Screening obstructive sleep apnea syndrome by home video
tape recording in children. Eur Respir J. 1996;9:2127-2131.
Carroll JL, Mc Colley SA, Marcus CL, Curtis S, Loughlin GM. Inability of clinical history to
distinguish primary snoring from obstructive sleep apnea syndrome in children. Chest.
1995;108:610-618.
Goldstein NA, Sculerati N, Walsleben JA, Bhatia N, Friedman DM, Rapoport DM. Clinical diagnosis
of pediatric obstructive sleep apnea validated by polysomnography. Otolaryngol Head Neck Surg.
1994;111:611-617.
Mc Colley SA, April MM, Carroll JL, Naclerio RM, Loughlin GM. Respiratory compromise after
adenotonsillectomy in children with obstructive sleep apnea. Arch Otolaryngol Head Neck Surg.
1992;118:940-943.
Nieminen P, Tolonen U, Lopponen H, Lopponen T, Luotonen J, Jokinen K. Snoring children:
factors predicting sleep apnea. Acta Otolaryngol Suppl. 1997;529:190-194.
Galvis AG. Pulmonary edema complicating relief of upper airway obstruction. Am J Emerg Med.
1987;5:294-297.
Marcus CL, Ward SL, Mallory GB, Rosen CL, Beckerman RC, Weese-Mayer DE, Brouillette RT,
Trang HT, Brooks LJ. Use of nasal continuous positive airway pressure as treatment of childhood
obstructive sleep apnea. J Pediatr. 1995;127:88-94.
Nieminen P, Tolonen U, Lopponen H. Snoring and obstructive sleep apnea in children: a 6-month
follow-up study. Arch Otolaryngol Head Neck Surg. 2000;126:481-486.
Elsherif I, Kareemullah C. Tonsil and adenoid surgery for upper airway obstruction in children. Ear
Nose Throat J. 1999;78:617-620.

26

ALGORITHM FOR UNCOMPLICATED OBSTRUCTIVE SLEEP APNEA SYNDROME IN CHILDREN


1
Child presents with snoring or
other symptoms suspicious for
OSAS
2

History and PE
suggestive of
OSAS

Intermittent screening on
follow-up
3

Cardio-respiratory
failure?

Screening studies:
Audiovisual taping
Overnight pulse oximetry
7
Nap study

Witnessed
apnea?

Refer to pediatric cardiologist


or pulmonologist specialist
preferably with sleep medicine
background

Laboratory
9
Polysomnography

Screening shows OSAS


is highly probable

10

PROCEED TO BOX 10

Is the patient a
candidate for
T & A?
High-risk
patients
may need PICU
admission post-op
for monitoring

Positive for
OSAS?

11

Treatment other
than T&A
implemented

12

Intermittent
screening
on follow-up

PROCEED TO BOX 10
Tonsillectomy & Adenoidectomy

13

14
PROCEED TO BOX 11; MAY ALSO
CONSIDER BOX 7 IF NOT YET DONE

Was surgery successful?


15

Appropriate follow-up
& monitoring

27

Evidence for Guidelines on Pediatric Obstructive Sleep Apnea


Author

Year

No.

Age

Diagnostic Technique

Caroll

1995

83

5.4m 14.8y

Questionnaire and
overnight PSG

Wang

1998

82

No mention

Overnight PSG

II

Leach

1992

93

18 m 12 y

Overnight PSG

Retrospective
III

Redline

1999

399

2 18 y

Home Overnight PSG

Cohort
II

Goldstei
n
Niemine
n
Marcus

1994

30

No mention

Audio recording, PSG

II

Obstructive Sleep Apnea (OSA) Score misclassified 1 in 4 patients; PS cannot be


distinguished from OSAS on history alone
Se 76.8%, Sp 71.4%, PPV 64.7%, NPV 83.3%
No significant association between clinical parameters and OSA
Highest PPV 46% for enuresis; highest NPV 100% for small tonsils
OSA by PSG had no significant association with age, sex, symptoms and obesity
OSA by PSG associated with cor pulmonale, tonsil hypertrophy and failure to
thrive
Moderate SDB associated with:
obesity (odds ratio 4.59; 95% CI, 1.58 13.33)
African-American race (OR 3.49; 95% CI, 1.56-8.32)
Not associated with sex and age
Independent predictors of SDB: obesity, proband
sampling, race and familial
clustering, sinus problems, persistent wheeze
Clinical assessment: Se 92.3%, Sp 29.4%, PPV 50.0%, NPV 83.3%

1997

78

< 18 y

Parents reports, PSG

II

No Se and Sp data; conclusion: OSA cannot be diagnosed without PSG

1998

67

Childhood OSAS associated with systemic diastolic hypertension

1996

58

II

Se 94.4%, Sp 68.2%, PPV 82.9%, NPV 88.2%

Goldstei
n

1994

30

No mention

III

Se 92.3%, Sp 29.4%, PPV 50.0%, NPV 83.3%

Marcus

1992

40

5.4 +/- 0.8 y

III

Nap studies: Se 74%, Sp 100%, PPV 100%, NPV 17%

Saeed

2000

143

1 18 y

Overnight pulse
oximetry & BP
monitoring
30-min video
recording, overnight
PSG
Questionnaire, audio
recording, overnight
PSG
Nap and overnight
PSG
Questionnaire, Nap
and overnight PSG

II

Sivan

OSAS 5 +/- 3
y
PS 8 +/- 4 y
No mention

Brouilett
e

2000

349

6 m 18 y

Overnight pulse
oximetry & PSG

Urschitz

2003

468

Overnight oximetry

Van

2000

120

3rd 4th grade


students
6 m 15.5 y

Nap parameters compared to overnight PSG:


Se 68.4%, Sp 60.4%, PPV 77.4%, NPV 49.2%
Normal to mildly abnormal nap studies should be confirmed by overnight PSG
Naps studies underestimate severity of OSA
Indeterminate 46%
Se 42.9%, Sp 97.8%, PPV 96.8%, NPV 53.1%
Oximetry may be used in the diagnosis of > 12 m children
May be a screening tool for children who will be referred for overnight PSG to
determine type and severity
Negative oximetry cannot rule out OSA
Defined SpO2 for children at sea level at >/= 98% with frequent falls >/= 4%; </=
90% rare
PSG contributes to assessing need for operation, likelihood of post op respiratory

Questionnaire,

Study Methodology
and Rating
Retrospective
III

Cross-sectional
III

II
Prospective survey

Results and Comments

Algorithm
Box
2

2
2

2, 7
2, 7

5
7

28

Somere
n
Marcus

1995

94

< 1 19 y

PSG, clinicians
impression
Questionnaire

III

Galvis
AG
Mc
Colley
Gozal

1987

20

<18 y

Chart review

III

1992

69

< 18 y

Chart review, PSG

III

1998

297

1st grade
students

Prospective cohort
II

Niemine
n
De
Serres

2000

58

3 10 y

Questionnaire,
overnight oximetry,
transcutaneous
partial pressure of
CO2
Overnight PSG

2002

101

6.2 +/- 2.5 y

Questionnaire

Retrospective
III

RCT
I
III

failure, or as a baseline or outcome measure


CPAP effective in 86%
Minor complications

11

Pulmonary edema may occur post op in children with severe obstruction; this is
sometimes unrecognized
Most significant risk factors for post op respiratory compromise: age < 3 y, AHI >
10.
High prevalence of snoring and nocturnal gas exchange abnormalities in
academically poor achievers with significant in improvement of grades after
intervention (usually tonsillectomy)

12

46.7% of subjects with OSA; 53.3 % with PS


78% of OSA patients cured after T&A
90% of children had improvement after adenotonsillectomy
large improvement 74.5%
moderate 6.1%
small 7.1%

13

12
13

13

29

UP-PGH DEPARTMENT OF OTORHINOLARYNGOLOGY CLINICAL PRACTICE GUIDELINES


THYROID MASSES
SCOPE OF THE PRACTICE GUIDELINE
This clinical practice guideline is for use by the Department of Otorhinolaryngology of the College
of Medicine - Philippine General Hospital, University of the Philippines Manila. It covers the
diagnosis and management of non-toxic thyroid masses. It excludes the management of
extremely rare malignancies of the thyroid gland such as lymphomas.
OBJECTIVES
The objectives of the guideline are: (1) to Identify points in the history and physical examination
that will help in the classification of thyroid neoplasms; (2) to recommend relevant diagnostic
examinations; (3) to highlight areas of controversy in the management; and (4) to suggest
treatment options.
LITERATURE SEARCH
This guideline is based on the Management Protocol for Head and Neck Malignancies developed
by the departments Head and Neck Division in 2002. A journal search using the Medline of
PubMed (full texts and abstracts were obtained) for more recent publications was done.
Keywords used were thyroid nodule, thyroid neoplasm and thyroid cancer. Very limited literature
containing prospective randomized control trials were obtained probably due to the need for a
very long follow-up. Current guidelines on the diagnosis and management of thyroid nodules
were also reviewed. The chosen articles were divided as follows:
Meta-Analysis of Randomized Controlled Trials:
Randomized Controlled Trials:
Well-Designed Clinical Studies without Randomization:
Well-Designed Quasi-Experimental Studies:
Well-Designed Non-Experimental Study:
Expert Committee Reports:

1
2
1
2
4
4

DEFINITION
Nodular goiter is the presence of a discrete mass within the substance of the thyroid gland.
Diffuse goiter is the enlargement of the entire thyroid gland.
Papillary carcinoma is a well-differentiated type of thyroid carcinoma derived from the thyroid
follicular cells. It is the most common malignant neoplasm of the thyroid gland. Generally, it is not
15
an aggressive tumor and it may be compatible with life.
Follicular tumor is of thyroid follicular cell origin. It is encapsulated, composed of follicles of
various histologic appearances. A follicular adenoma can only be differentiated from a follicular
1
carcinoma microscopically. Capsular and/or vascular invasion are found in follicular carcinoma.
Hurthle cell carcinoma or oncocytic neoplasms are composed of cells with abundant pink
(oxyphilic) cytoplasm containing ample abnormal mitochondria on ultrastructural examination.
Majority of these lesions are benign. As with follicular carcinoma, presence of capsular or
vascular invasion is a prerequisite for the diagnosis of malignancy. They are more aggressive
than the conventional papillary or follicular carcinoma, suggesting an intermediate-grade
13
malignant behavior.

30

Medullary carcinoma is a malignant tumor derived from the calcitonin-secreting parafollicular Ccells of the thyroid. Occurring in less than 10% of cases, it may arise spontaneously, or as part of
a familial pattern of inheritance (MEN Syndrome). It is associated with mutations in the RET
13
proto-oncogene in chromosome 10.
Anaplastic carcinoma is an undifferentiated carcinoma of the thyroid gland that is clinically very
aggressive---characterized by rapid growth, infiltration of the surrounding tissues and easy
spread. It may also arise as a de-differentiation from an existing well-differentiated papillary or
13
follicular carcinoma. All patients die, mostly due to respiratory compromise caused by the tumor.
Risk stratification is the classification of well-differentiated CA into low, intermediate and high
risk based on given parameters. The panel adopted the Memorial Sloan-Kettering Cancer Center
14
scheme.
Table 1: Risk Stratification for Thyroid Carcinoma
Age
Distant
Metastasis
Tumor size
Histology and
grade

LOW
<45
M0

INTERMEDIATE
<45
M+

INTERMEDIATE
>45
M0

HIGH
>45
M+

T1, T2
(<4cm)
Papillary

T3, T4
(>4cm)
Follicular &/or
High-grade

T1, T2
(<4cm)
Papillary

T3, T4 (>4 cm)


Follicular &/or
High-grade

PREVALENCE
The incidence of clinically apparent thyroid nodule in the general population is approximately 4%
to 5%. However, in autopsy studies, thyroid nodularity is approximately 37%. The incidence of
1
malignancy in a solitary thyroid nodule is 10 15% .
In the Philippines, thyroid mass occurs in 6.6 / 100,000 of the general population. 3.1 / 100,000
males and 9.8 / 100,000 females are affected (Philippine Cancer Registry).
In the PGH Department of ORL outpatient clinic, 28% of the new patients consulted for thyroid
mass in the year 2002 (Annual Report 2002).

31

RECOMMENDATIONS ON THE DIAGNOSIS OF THYROID NODULES


1.

Clinical evaluation of patients with thyroid


comprehensive history and physical examination.
Grade C Recommendation

enlargement

begins

with

1.1

The following elements of history and physical exam favor benign disease but do
16,17
not exclude the presence of thyroid cancer:
1.1.1 Soft, smooth, mobile, doughy solitary nodule
1.1.2 Multinodular goiter without a dominant nodule
1.1.3 Symptoms of hypo- or hyperthyroidism
1.1.4 Pain or tenderness associated with the nodule
1.1.5 Family history of Hashimotos thyroiditis or autoimmune disease
1.1.6 Family history of benign thyroid nodule or goiter

1.2

The following are points of history and physical examination increasing the
suspicion of malignant thyroid disease:
1.2.1 Solitary (versus multinodular), hard (versus doughy), fixed (versus
mobile) nodule
1.2.2 Rapid growth (doubling of size in 6 months)
1.2.3 Vocal cord paralysis
1.2.4 History of irradiation to the neck during childhood or adolescence
1.2.5 Age (very young at <20, or older at >60)
1.2.6 Gender (male)
The proportion of nodules that are malignant in males is double
15
compared to females.
1.2.7 Recurrent cystic nodule
1.2.8 Presence of lateral neck nodes
1.2.9 Presence of distant (pulmonary) metastasis

Complete examination of the head and neck area includes not only inspection and
palpation of the thyroid gland but also the lateral aspects of the neck for cervical
lymphadenopathy. Laryngoscopy to document the mobility of vocal cords is a must.
2.

TSH and T4 assays should be done for all patients with thyroid enlargement, with
or without functional disturbance.
Grade B Recommendation
It is important to establish the status of the thyroid function, as this would dictate the initial
medical management. TSH and T4 assays are requested for screening purposes only,
that is, to determine the presence of hyperthyroidism or hypothyroidism. Special cases
will be co-managed with the endocrinologists. The cost-effectiveness of requesting free
T4 as a screening diagnostic tool is being questioned especially for indigent patients.
Only rarely do patients with malignant solitary nodules have hyperthyroidism or
hypothyroidism. An abnormal TSH level decreases the suspicion but does not eliminate
17
the possibility of malignancy.

3.

FNAB should be done for all cases of thyroid nodules and enlargement of the
thyroid suspicious for malignancy (lymphoma, anaplasic carcinoma, medullary
carcinoma, metastatic tumor).
Grade B Recommendation
FNAB is the cornerstone in the evaluation of solitary thyroid nodules and dominant
6
nodules within multinodular goiters. If done properly, sensitivity is 83.9%. The results
can generally be divided into malignant, benign, suspicious or insufficient/indeterminate.

32

4.

Thyroid ultrasound is not routinely recommended in the initial evaluation of a


thyroid nodule.
Grade B Recommendation
The ultrasound is sensitive in determining the size and number of nodules. This may
provide a sensitive and objective indicator of whether a nodule is increasing or
decreasing in size over time. It differentiates between a cystic and a solid nodule but not
between a benign and malignant nodule. Its ability to identify good surgical candidates
6
without the assistance of other diagnostic modalities is very limited.
The indications for requesting a thyroid ultrasound are:
4.1
Differentiate between a cystic and solid nodule
4.2
Differentiate thyroid from extra-thyroid masses in the neck
4.3
Determine the location of a thyroid nodule of interest
4.4
Provide baseline measurement to monitor clinical response of obscure nodules
to medical treatment
4.5
Provide patient and/or physician reassurance of a doubtful thyroid enlargement

5.

Thyroid scan is not routinely recommended in the initial evaluation of a thyroid


nodule.
Grade B Recommendation
The thyroid scan may be helpful in the evaluation of thyroid nodules, specifically its
functional nature (hot or cold). The incidence of malignancy in cold thyroid nodules is
approximately 20% and that in hot thyroid nodules is less than 5%. (sensitivity 91%,
specificity 19%). Only 10% of nodules are delineated as benign; hence results are
16
uncertain in the remaining 90% (sensitivity 91%, specificity 19%). Thyroid scan is
recommended for nodular toxic goiters but will not differentiate a benign from a malignant
6
mass.

6.

Chest X-ray, MRI or CT scan are not routinely done for patients with thyroid
neoplasm.
Grade C Recommendation
The imaging tests are reserved for clinical cases where the true extend of tumor
involvement cannot be clinically established. They are used to evaluate for possible
metastatic disease and when there is a suspicion of tumor extension to the larynx,
trachea or mediastinum.

RECOMMENDATIONS ON THE MANAGEMENT OF THYROID NODULES


BENIGN NODULE
1.

Levothyroxine suppression may be used as management for benign thyroid


nodules.
Grade B Recommendation
Several studies have shown levothyroxine suppression to be effective in shrinking
10,19
nodules, particularly those less than 4 cm.
There are also randomized controlled trials
18
that have failed to document its efficacy. Most clinicians use it for a limited time (6-12
months) with the serum TSH maintained in the range of 0.1 to 0.3 mU/mL in an attempt
to decrease the risks of long-term suppressive therapy like osteoporosis, cardiac
hypertrophy and atrial fibrillation. Although there is an enduring controversy regarding the
role of levothyroxine suppression treatment for patients with benign thyroid nodules,
some patients may benefit from it. Individualized clinical judgment is recommended.

33

The indications for medical treatment are: (1) nodule less than 4 cm with a stable
pattern of growth; (2) nodule bigger than 4 cm but with a clinically slim chance of
malignancy; and (3) patient opts for a trial of medical treatment before surgery
Patients with thyroid nodules in whom malignancy has been excluded require
periodic clinical observation with judicious use of laboratory tests, imaging procedures,
needle biopsy and levothyroxine sodium suppression therapy. The goals of follow-up are
(1) to recognize progressive enlargement that could result in local compressive and
invasive complications (e.g. dysphagia, cough, pain, dyspnea, hoarseness) or cosmetic
concerns or signs of malignancy; (2) to diagnose associated clinical or subclinical thyroid
dysfunction; and (3) to identify patients in whom there may be an undiagnosed or
subsequent thyroid malignancy.
During the course of follow-up, repeated FNAB may be required in the following
situations:
1.1
increase in size regardless of medical treatment
1.2
development of new clinical features suggestive of malignancy
1.3
indeterminate FNAB done previously
nd
FNAB may be done twice if the first reveals indeterminate results. If the 2 FNAB
rd
rd
has still inconclusive results, a 3 FNAB may be done by the Pathologist. If the 3 FNAB
is still indeterminate, then surgery may be done with frozen section.

2.

Surgery is another option in the management of benign thyroid nodules


Grade C Recommendation
The absolute indications for surgery are obstructive symptoms and hemorrhage
(iatrogenic or spontaneous). Non-response to medical treatment and cosmesis are
relative indications for surgery. Some clinicians would resort to surgery when there is an
increase in size during suppressive therapy without repeating the FNAB.

THYROID CANCER
1.

Surgery is the primary mode of management for thyroid cancer.


Grade B Recommendation
Basic considerations in the management of thyroid cancer are the following:
1.1
Outcome is generally excellent.
1.2
Prognostic and risk factors are well-defined.
1.3
Generally, a low-risk patient has excellent outcome.
1.4
Risk group stratification is the main factor in treatment decisions.
1.5
High-risk groups are well-defined and need aggressive treatment with total
thyroidectomy and radioactive iodine (RAI) therapy.
1.6
The role of RAI in low-risk groups is currently not well-defined.
1.7
The presence of nodal metastasis has few prognostic implications.
1.8
Age is the most important prognostic factor.

34

2.

Well-differentiated thyroid cancers are classified into low, intermediate and highrisk.
Grade B Recommendation

Age
Distant
Metastasis
Tumor size
Histology and
grade
5-year survival
(%)
20-yr survival
(%)
3.

LOW
<45
M0

INTERMEDIATE
<45
M+

INTERMEDIATE
>45
M0

HIGH
>45
M+

T1, T2
(<4cm)
Papillary

T1, T2
(<4cm)
Papillary

100

T3, T4
(>4cm)
Follicular &/or high
grade
96

96

T3, T4
(>4 cm)
Follicular &/or
high grade
72

99

85

85

57

Papillary thyroid cancer (PTC)


Grade B Recommendation
A unilateral lobectomy and isthmusectomy is recommended for minimal PTC (less than 1
16,17
cm.
There is a continuing debate between doing a total thyroidectomy or just a
1, 15
lobectomy for low-risk patients
. Total or near-total thyroidectomy is recommended in
the following situations:
3.1
Intermediate and high-risk patients
3.2
Presence of bilateral nodules
3.3
Extension of the primary tumor beyond the thyroid capsule
3.4
Presence of local or distant metastases
Central and lateral neck dissection is recommended for patients with clinically palpable
nodes.

4.

Follicular or Hurthle cell cancer


Grade B Recommendation
Follicular adenomas and carcinomas are difficult to distinguish at the time of surgical
intervention. Frozen section is necessary but has a limited value if the cytologic
diagnosis is that of a follicular tumor.
A unilateral lobectomy and isthmusectomy is recommended. If the mass is benign on
final histopathology, no further therapy is needed. However, If it is malignant, completion
(total) thyroidectomy is indicated.
A histologic diagnosis of a follicular thyroid carcinoma immediately places the patient in
the intermediate-risk category, at the very least. Thus, a total or near-total thyroidectomy
is warranted.
Central and lateral neck dissection is recommended for patients with clinically palpable
nodes.

35

5.

Medullary thyroid cancer


Grade B Recommendation
Management precludes a total thyroidectomy with central neck dissection and ipsilateral
modified radical neck dissection. Furthermore, the patient and his family should undergo
screening and evaluation by an endocrinologist.

6.

Anaplastic thyroid cancer


Grade B Recommendation
Surgical treatment is of limited use and is indicated primarily for relief of airway
obstruction.
External beam radiotherapy can aid in local disease control, although anaplastic thyroid
cancer is generally considered a radioresistant tumor compared with other solid
neoplasms. There is reported improvement in overall survival and respectability with the
use of external beam radiotherapy preoperatively and in combination with
15
chemotherapy.

7.

Adjuvant treatment
Grade B Recommendation
Postoperative adjuvant treatment consists of:
7.1
Radioactive iodine scan In well-differentiated thyroid cancers, it is
recommended when there is:
7.1.1 Distant metastasis
7.1.2 Gross residual tumor following surgery
7.1.3 High risk of local recurrence following total thyroidectomy for a large
tumor
7.1.4 Resection of multiple lymph node metastasis in the lateral compartment
of the neck or superior mediastinum
7.2
Levothyroxine suppression It is recommended to keep TSH level as low as
possible.
7.3 External beam radiation therapy It is used for cancers with a poorly- differentiated
histology. It is helpful for patients with residual tumor in the central compartment of
the neck, particularly if the tumor uptake of radioactive iodine is poor.

36

Anterior
Neck Mass

History Physical
Examination
TSH, T4
Refer to
Endocrinology
for Medical
Management

Hyperthyroid?

Diffuse?
Risk
Stratification

Fine Needle
Aspiration Biopsy
Lobectomy w/
Isthmusectomy; or
Near total/Total
Thyroidectomy;
No adjuvant
treatment

Low Risk?

Well
Differentiate
d? (Yes, if
Papillary or
Follicular)

Definitely
Malignant?

Definitely
Benign?

Total Thyroidectomy
Post-op RAI/
LT4 Suppression

3
Medullary
Carcinoma?
Total Thyroidectomy,
Neck Dissection; Post
operative Radiotherapy

Repeat FNAB
Anaplastic?
Total Thyroidectomy;
Radiotherapy

Definite
Diagnosis?

Secure
Airway,
Radiotherap
y

37

LT4 Suppression
x 6 months
Continue
LT4
x 6 months
Decrease in
size?
Continue LT4
x 6 months
(monitor TSH
levels, should not
be less than 0.1
mU/mL)

Decrease
in size?

Poor surgical risk


or no consent?
RAI

Subtotal
Thyroidectomy
3

>4

Thyroidectomy

cm
?
LT4 Suppression
x 3 mos

Thyroidectomy w/
Frozen Section
Decrease
in Size?

Continue LT4
Suppression x 3
mos

Thyroidectomy

Final Histopath
Benign?

End of
treatment

Frozen
Section:
Benign?

Risk Stratification

Risk Stratification
Low
Risk?
Low
Risk?

Completion Thyroidectomy,
RAI, LT4 Suppression

Observe
Follow-Up

Observe

Lobectomy w/
Isthmusectomy, OR
Near total/Total
Thyroidectomy;
No adjuvant treatment

Total
Thyroidectomy,
LT4 Suppression,
RAI

38

REFERENCES
rd

1. Cummings C, et al. Otolaryngology, Head and Neck Surgery 3 ed. Vol 1. Mosby-Year
Book Inc., St. Louis, Missouri, 1998.
2. Huysmans DA, Hermus RMM, Corstens FHM, Barentsz J and Kloppenborg KWC, Large,
Compressive Goiters Treated with Radioiodine. Annals of Internal Medicine. 121:757-62.
Nov 1994.
3. Massaterri E & Lkoos R. Current Approaches to primary therapy for papillary and
follicular thyroid cancer. Journal of Clinical Endocrinology and Metabolism, 86(4): 144763.
4. Hegedus L, Nygaard B & Hansen JM. Is routine thyroxine treatment to hinder
postoperative recurrence of nontoxic goiter justifies? Journal of Clinical Endocrinology
and Metabolism, 84(2): 756-760, 1999.
5. Huysmans DA, Nieuwlaat W, Erdtsieck RJ, Schellekens AP, Bus JW, Bravenboer B, and
Hermus AR. Administration of a Single Low Dose of Recombinant Human Thyrotropin
Significantly Enhances Thyroid Radioiodide Uptake in Nontoxic Nodular Goiter. Journal
of Clinical Endocrinology and Metabolism, 85(10): 3592-3596. 2000
6. Kountakis MD et al. The Radiologic work-up in thyroid surgery: fine needle biopsy
versus scintigraphy and ultrasound. Ear, Nose Throat Journal, 81(3): 151-4. Mar 2002.
7. Medical Oncology Section, Department of Medicine, Philippine General Hospital, College
nd
of Medicine, University of the Philippines. Handbook on Basic Medical Oncology, 2 Ed.
2001
8. Nuria A, Lucas A, Salinas I, Castella E, Sanmarti A. Frozen Section in a cytological
diagnosis of thyroid follicular neoplasm. The Laryngoscope, 113: 563-6, Mar 2003.
9. Nygaard B, Hegedus L, Gervil M, Hjalgrim H, Soe-Jensen P, and Hansen JM.
Radioiodine treatment of multinodular non-toxic goitre. British Medical Journal,
307(6908): 828-832, Oct 1993.
10. Papini E, Petrucci L, Guglielmi R, Panunzi C, Rinaldi R, Bacci V, Crescenzi A, Nardi F,
Fabbrinni R and Pacella CM. Long-term changes in nodular goiter: a 5-yr prospective
randomized trial of Levothyroxine suppressive therapy for benign cold thyroid nodules.
Journal of Clinical Endocrinology and Metabolism, 83(3): 780-3, 1998.
11. Petrone, Louis R. A Primary Care Approach to the Adult Patient with Nodular Thyroid
Disease. Archives of Family Medicine 5(2): 92-100, Feb 1996.
12. Samuels MH. Evaluation & Treatment of Sporadic Nontoxic Goiter-Some Answers &
More Questions (editorial). Journal of Clinical Endocrinology and Metabolism, 86(3):
994-7
13. Shah, S. Atlas of Clinical Oncology Center of the head and Neck. BC Decker Inc.
Hamilton London 2001.
14. Shaha, A. Controversies in the Management of Thyroid Nodule. The Laryngoscope, 110:
183-93, Feb 2000.
15. Thawley, et al. Comprehensive Management of Head and Neck Tumors. Vol 2. W.B.
Saunders Company, 1999.
16. Thyroid Carcinoma Task Force. AACE/AAES Clinical Practice guidelines for the
diagnosis and management of thyroid nodules. Endocrinology Practice 2(1): 80-4,
Jan/Feb 1996.
17. Thyroid Carcinoma Task Force. AACE/AAES Medical/surgical guidelines for clinical
practice: management of thyroid carcinoma. Endocrinology Practice, 7(3): 203-20, MayJune 2001.
18. Wesche, MFT, Tiel-v Buul MMC, Lips P, Smits NJ and Wiersinga WM. A Randomized
Trial Comparing Levothyroxine with Radioactive Iodine in the Treatment of Sporadic
Nontoxic Goiter. Journal of Clinical Endocrinology and Metabolism, 86(1): 998-1005. Oct
2000.
19. Zelmanovitz F, Genro S and Gross JL. Suppressive therapy with levothyroxine for
solitary thyroid nodules: A double-blind controlled clinical study and cumulative metaanalyses. Journal of Clinical Endocrinology and Metabolism, 83(11): 3881-5, 1998.

39

UP-PGH DEPARTMENT OF OTORHINOLARYNGOLOGY CLINICAL PRACTICE GUIDELINES


CLEFT LIP, ALVEOLUS AND PALATE (CLAP) IN CHILDREN AND ADOLESCENTS
SCOPE OF THE PRACTICE GUIDELINE
This clinical practice guideline is for use by the Department of Otorhinolaryngology of the College
of Medicine - Philippine General Hospital, University of the Philippines Manila in cooperation with
the other members of the multi-disciplinary CLAP team. It provides a systematic approach to the
diagnosis and management of cleft lip and palate deformities in newborns up to adolescents.
OBJECTIVES
The objective of the guideline is to provide a medically-inclined and family-centered care for
children and adolescents with cleft lip and palate that employs a multi-disciplinary team, working
together at all times throughout the growth of the child.
LITERATURE SEARCH
The National Library of Medicines Pubmed database was searched for literature using Boolean
method on medical subject headings: cleft lip MeSH and cleft palate MeSH; middle ear ventilation
MeSH; palatal prosthesis MeSH randomized clinical trial MeSH, controlled clinical trials MeSH,
Meta-Analysis MeSH; Epidemiologic Studies MeSH. Specific clinical questions were answered
using the medical subject headings. There were 22 researches used in the guideline
development. Ten different protocols from international institutions were used as patterns for the
formulation of the clinical practice guideline. The chosen articles were divided as follows:
Meta-analysis
Randomized controlled trial
Non-randomized controlled study
Descriptive study
Committee report

0
5
0
21
10

DEFINITION
Cleft lip and palate is a congenital anomaly presenting in wide varieties of forms and
combinations. It is failure of fusion of embryonal facial clefts. Cleft lip ranges from
notching of the lip to a complete cleft, involving the floor of the nose. It may be associated
with a cleft of the primary palate (alveolus/pre-maxilla) and with clefts of the secondary
palate (hard and soft palate). Cleft lip can further be described as unilateral or bilateral,
10,33
complete or incomplete.
Cleft palate may occur in isolation ranging from a bifid uvula to a complete cleft of hard
and soft palate. It may also present in a submucous form. It can also be classified as
unilateral or bilateral. Clefts may be part of several syndromes affecting the first and
10,33
second branchial arches, including the Pierre Robin sequence.
CLAP team is made up of the following:
OTORHINOLARYNGOLOGIST (Cleft Surgeon)
Performs plastic and reconstructive surgery on the cleft lip and the palate including
scar revision and rhinoplasty
Prevents and manages otologic infections
PEDIATRICIAN
Oversees the well-being of the child including the normal growth and development
Ensures that the child is physically fit for the surgical procedures
PEDIATRIC DENTIST / PEDODONTIST
Takes care of the childs dentition
ORTHODONTIST
Helps to establish proper shape to the dental arches

40

Works to achieve a normal dental arch prior to bone graft surgery and maintain its
integrity
PROSTHODONTIST
Provides the prosthetic devices (e.g. obturator, bridge, retainer, implant)
AUDIOLOGIST
Checks the child's hearing regularly and makes the necessary recommendations
SPEECH AND LANGUAGE PATHOLOGIST
Assists the child in producing intelligible language
Provides therapy in areas of articulation and language development depending upon
the child's unique needs
GENETICIST
Helps the family gain an understanding of the predisposing factors and determine risk
of recurrence
MEDICAL SOCIAL WORKER
Assists the family in dealing with non-medical issues that will affect the over-all
treatment of the child and the family
Provides access to appropriate resources and support
PSYCHOLOGIST
Works with the child, parents and the family to ensure normal functioning
Provides intervention on issues such as parental adjustment and cleft child selfesteem
PARENTS SUPPORT GROUP
Establishes the link between families and the CLAP team for a better understanding
of the care pathways
PREVALENCE
Cleft lip and palate represents the second most frequently occurring congenital deformity. The
incidence of cleft lip and palate varies considerably according to race. The incidence among
Caucasians is 1:1000 live births, while American Indians is 3.6:1000 live births. The incidence for
4
Asians is slightly higher, Japanese 2.1:1000 live births and Chinese, 1.7: 1000 liver births.
According to a census by the Philippine Birth Defects Registry Project from 1999-2001, cleft lip
and palate is the third most common birth defect in the Philippines (first is multiple congenital
anomalies, second is ankyloglossia). A total of 110 cases of cleft lip and palate were tallied,
5.6:10,000 live births. In a census done in PGH from 1996-2000, there were 378 cases of
bilateral cleft lip (associated cleft palate not specified), 208 cases of cleft lip with palate and 188
cases of cleft lip alone.
In 2002, an average of 21 CLAP patients per month was seen at the ORL outpatient clinic of the
Philippine General Hospital. Four to eight cleft operations per month were performed.
CLAP OPD CENSUS FOR 2002
CLAP, type not indicated
CLAP, bilateral, complete
CLAP, unilateral, complete
CLAP, incomplete, bilateral
CLAP, incomplete, unilateral
Cleft lip, unilateral complete
Cleft lip, unilateral, incomplete
Cleft lip, bilateral, complete
Cleft lip, bilateral, incomplete
Cleft palate, unilateral incomplete
Cleft palate bilateral, complete
Cleft palate, bilateral, incomplete

5
11
16
2
1
2
2
1
1
13
1
2

41

Complete cleft lip and alveolar cleft


Incomplete cleft lip and alveolar cleft
CLAP complete in 1 side and incomplete
palate on the other side

3
1
4

Incomplete cleft lip and alveolar cleft on


one side and incomplete cleft lip
On the other side

Total OPD Census:

66

CLAP OR CENSUS FOR 2002


Cleft lip, incomplete; cleft palate, complete
Cleft lip, incomplete; cleft palate,
incomplete
Cleft lip, complete; cleft palate, complete
Cleft lip, complete; cleft palate, incomplete
Cleft palate, incomplete
Cleft palate, complete
Cleft lip, incomplete
Cleft lip, Complete
Total OR Census:

1
4
19
1
14
2
2
7
50

RECOMMENDATIONS ON THE DIAGNOSIS OF CLEFT LIP AND PALATE


Initial Head and Neck Examination
The head is inspected for symmetry. The auricle and the external ear canal are checked for
development and location. A facial analysis is helpful to identify abnormalities of facial symmetry
and harmony. Otologic examination includes pneumatic otoscopy and tuning fork tests. Cleft
palate is commonly associated with Eustachian tube dysfunction due to an abnormal insertion of
the levator and tensor veli palatini muscles in the posterior margin of the hard palate. Anterior and
posterior rhinoscopy will identify clefting, septal abnormalities, intranasal masses and choanal
atresia. Oral cavity examination will reveal any cleft, dental arch abnormalities and tongue
anomalies such as bifid tongue, macroglossia, glossoptosis, or lingual thyroid. In addition,
malocclusion, hemifacial hypertrophy or atrophy, and facial clefting are documented. The upper
airway tract is evaluated by assessing the adequacy of phonation, cough, and deglutition, and by
10
auscultating and palpating the neck.
Nomenclature
Cleft lip and palate patients will be classified according to the Thallwitz nomenclature and ICD-10
system.
34

The Thallwitz nomenclature (also known as the LAHSHAL) is a descriptive classification since
site, size, extent and type of cleft are considered. Severity of the deformity is objectively
documented and the recorded findings can easily be stored into a computer for data analysis.
Each area is divided into thirds, and cleft defects are graded as to extent of affected areas.
Grading is done for both sides as shown:

42

(right side)

(midline)

(left side)

L-lip A-alveolus H-hard palate S-soft palate H-hard palate A-alveolus L-lip

L = Lip - 1/3 or 2/3 or 3/3

A = Alveolar cleft - 1/3 or 2/3 or 3/3

H = Hard palate cleft - 1/3 or 2/3 or 3/3

S = Soft palate cleft - 1/3 or 2/3 or 3/3

The ICD-10 system is an international standard of coding.


Cleft hard and soft palate with cleft lip, bilateral
Cleft hard and soft palate with cleft lip, unilateral
Cleft hard palate with cleft lip, bilateral
Cleft hard palate with cleft lip, unilateral
Cleft hard palate with cleft soft palate, bilateral
Cleft hard palate with cleft soft palate, unilateral
Cleft hard palate, bilateral
Cleft hard palate, unilateral
Cleft lip
Cleft lip, bilateral
Cleft lip, medial
Cleft lip, unilateral
Cleft palate
Cleft palate with cleft lip
Cleft palate, medial
Cleft palate, unspecified, bilateral
Cleft palate, unspecified, unilateral
Cleft soft palate with cleft lip, bilateral
Cleft soft palate with cleft lip, unilateral
Cleft soft palate, bilateral
Cleft soft palate, unilateral
Cleft uvula

Q374
Q375
Q370
Q371
Q354
Q355
Q350
Q351
Q36
Q360
Q361
Q369
Q35
Q37
Q356
Q358
Q359
Q372
Q373
Q352
Q353
Q357

RECOMMENDATIONS ON THE MANAGEMENT OF CLEFT LIP AND PALATE


BIRTH 6 MONTHS
1. Registry in the Congenital Registry of the National Institutes of Health
Grade C Recommendation
Cleft lip and palate ranks third among the top ten birth defects for 1999-2001 as reported by
the Philippine Birth Defects Registry Project. Data gathered is used for researches.
Moreover, these can be used in policy making and in recommending services needed by
patients with congenital anomalies.
2. Speech development
Grade C Recommendation

43

Parents will be educated on normal speech and language development and they will be
taught vocal play.
3. Evaluation of feeding and growth parameters
Grade C Recommendation
This is a concerted effort from rehabilitation medicine, pediatrics, and prosthesis to improve
32
patients feeding. Turner et al noted that the combined use of palatal obturator and lactation
education reduced feeding time, increased volume intake and was associated with good
growth. Mothers who had desired to breast-feed elected to use the obturator to support high
volume intake, and decrease infant fatigue.
Feeding instructions, molding appliance fitting and feeding plate modification are done. A
21
study by Konst showed that children treated with intra-oral prosthesis during their first year
of life followed a more normal path of phonological development between 2 and 3 years of
32
age . Infant orthopedics or intraoral prosthesis has a temporary effect on maxillary arch
28
dimensions, which does not last beyond surgical soft palate closure.
4. Parental education and support
Grade C Recommendation
Psychiatric consultation and support is started.
5. Otologic evaluation
Grade A Recommendation
Evaluation of hearing status including newborn hearing screening is important. Aggressive
otologic management has been recommended for children with cleft palate because of the
almost universal occurrence of otitis media with effusion (OME) and the association of OME
5
with hearing loss and possible language, cognitive, and academic delays. An otoacoustic
emission test (OAE) or an auditory brainstem response (ABR) test is used as hearing
31
screening in newborn with cleft lip and palate .
7

A study by Ceponiene showed that reduced mismatch negativity (MMN) amplitudes in cleft
children imply deficiency in auditory STM trace maintenance. This dysfunction is likely to
contribute to their language and learning disabilities.
6. Genetic evaluation
Grade C Recommendation
Other congenital defects and syndromes are identified and treat accordingly (e.g. airway
obstruction in Pierre Robins sequence).
7. General pediatric consultation for routine immunization and well baby check-ups.
8. Monthly follow-up with the CLAP team at the Department of ORL.
6 MONTHS 1 YEAR
1. One-stage operation for unilateral cleft lip and cleft palate
Single stage modified Millard with alar plasty and two-flap palatoplasty
Optional procedures: Alveolar bone grafting
Ventilation tube insertion
Grade C Recommendation
A one-stage operation for lip and palatal defect from 6 to 9 months of age is recommended
since indigent patients have difficulty in following up regularly for multi-staged procedures
18
(often due to financial and geographic constraints). Isaac Kaplan performed the earliest
record of a simultaneous surgery for cleft lip and cleft palate in 1972. His study includes 13
rd
th
infants who underwent one stage surgery for cleft lip and cleft palate at the 3 to 4 month of

44

age. The one staged procedure shortcuts the classical recommendation of repairing the cleft
rd
th
lip at 3 months of age followed by closure of the palate by 6 months of age.
Controversies abound the timing of surgery for patients with cleft lip and cleft palate. In terms
of speech development, palatal defects closed before the babbling of words would
reasonably prevent hypernasal speech caused by the escape of air through the naso-oral
20
fistula. Kirschner compared 40 children with surgery done at 3 to 7 months of age with 50
children whose surgery was done after 7 months of age. The study revealed no significant
difference in speech outcome between the 2 groups.
Infants subjected to mid-facial surgery have a greater risk of impaired maxillary growth.
8
However, Choudhary demonstrated satisfactory outcomes on long-term midfacial growth
using Veau-Wardill-Killner technique for cleft palate done at 9 to 12 months of age.
15

Regarding the choice of surgical technique, Holtmann and Wray , in a prospective


randomized study, compared triangular cleft lip repair with the Millard rotation-advancement
procedure. The most significant difference between the two approaches was a greater
frequency for hypertrophic scars formation following the rotation-advancement repair.
However, the hypertrophied scar resolved 18 months after surgery in majority of patients.
They found no major differences in the appearance of the lip and nose. Both surgeons felt the
rotation-advancement repair allowed better fine tuning during surgery as compared to the
triangular flap repair.
36

Zheng et al reported that tympanotomy and pressure equilibrium tube insertion during
palatoplasty resolved 48.7% of the ears with otitis media with effusion (OME). Furthermore,
the hearing level improved by about 17decibels six months after the operation. These results
14
were supported by the study of He et al wherein they compared the influence of
palatoplasty and tympanotomy on middle ear function (hearing condition) in cleft palate
patients. They recorded the pre- and post-operative hearing levels and middle ear function of
two groups: (1) 22 ears with OME and cleft palate with VT tube insertion and (2) 38 patients
with cleft palate who underwent palatoplasty. They reported that VT tube insertion and
tympanotomy changed the pressure conditions of the middle ear cavity, raising the hearing
level to about 17decibels in the middle-ear-diseased cleft palate patients. The patients who
had palatoplasty alone did not show obvious changes in middle ear function.
Although arm restraints have been traditionally used after cleft surgery, several authors have
25
debunked this practice. ORiain did not find any case where straying fingers caused
disruption of the suture line in his study of 24 cleft lip repairs. Similarly, in a prospective,
16
randomized trial of 46 children having primary cleft palate repair, Jigjinni et al showed that
arm splints did not decrease the incidence of oro-nasal fistulas.
Breast-feeding has been almost universally discouraged in infants undergoing cleft lip repair
on the basis that muscular activity will jeopardize the surgical repair. Thus, the practice of
cup/spoon/dropper feeding has been unchallenged by succeeding generations of plastic
11
surgeons. Darzi, Chowdri and Bhat performed a prospective randomized study to
determine whether breast-feeding in the early post- operative period would in any way be
harmful for the child with cleft lip repair. 40 mothers were randomized into two groups, 20 for
breast-feeding and 20 for spoon-feeding. Cleft lips were repaired by either a triangular flap
technique or by a rotation-advancement technique. They had only one partial wound
dehiscence in a spoon-fed baby who fell from his bed on the third post-op day.
2. Initiation of intensive speech therapy after single stage CLAP repair
3. Continuation of general pediatric follow-up and nutrition evaluation
4. Dental evaluation and care during primary tooth eruption

45

5. Follow-up every 3 months with the CLAP team at the Department of ORL
1 YEAR 5 YEARS
1. Psychosocial assessment
Grade C Recommendation
This is the stage when body image and self-esteem are developing. Intervention of a child
psychiatrist may be necessary. Erik Eriksson calls this the autonomy versus shame stage.
Shame occurs when the child is overtly self-conscious because of negative exposure. Cleft
lip and palate children are often teased for their deformity. Psychological help is needed to
lessen insecurity and to promote a healthy body image.
2. Routine pediatric care for children entering school
3. Articulatory and phonetics rehabilitation before school at 1-4 yrs old
Grade C Recommendation
A child usually utters his or her first word at 12 months of age. Logically, it would be beneficial
to rehabilitate the patient after surgery, at the time when the child is starting to develop
language skills.
nd

4. Assessment for 2 stage procedures at 3-4 yrs of age


Grade C Recommendation
Velopharyngeal competency is assessed and pharyngoplasty is done if incompetent.
Collumellar lengthening may be done for bilateral cleft
The importance of normal speech for successful socialization cannot be overestimated.
Surgery that simply restores normal palatal anatomy cannot be considered a success if the
result is crippled speech. The rightful goal of cleft palate repair is normal velopharyngeal
function. Persistent velopharyngeal defect (VPD) after cleft palate repair is characeterized by
hypernasal resonance and nasal air escape. Significant VPD may be associated with the
development of compensatory errors in articulation that may further impair speech
intelligibility.
5. Dental and orthodontic follow-up.
6. Follow-up every 6 months with the CLAP team at the Department of ORL.
8 10 YEARS
1. Alveolar bone grafting
Grade C Recommendation
The alveolar bone graft in an alveolar cleft has many advantages, namely: (1) assists in the
closure of buccoalveolar oronasal fistula; (2) provides bony support for unerupted teeth and
teeth adjacent to the cleft; (3) forms a continuous alveolar ridge to facilitate orthodontic
correction of malocclusion; (4) supports the nasal floor and the base of the alae to improve
3
nasal aesthetics. According to Bergland , the best time to do secondary bone grafting is from
12
9-11 years of age when the canine tooth has not erupted. Deeb noted a most favorable
prognosis for patients with alveolar graft when there is a - canine root formation (9-12
years of age).
2. Orthodontic re-evaluation and treatment

46

3. Yearly follow-up
4. Higher level language and speech class
5. Continued psychiatric support
16 19 YEARS
1. Orthognathic surgery for malocclusion and prognathism
Rhinoplasty for aesthetic purposes 1 year after orthognathic surgery
Aesthetic surgery
Grade C Recommendation
Primary and secondary management of cleft lip and palate in the adolescent patients vary
from one center to another. Treatment is often individualized. Patient, parental and physician
expectations should be discussed. Concerns regarding secondary surgeries conspicuous
lip scars, unnaturally wide central lip, flaring alae with wide nostril floors, short columella with
flat nasal tip are addressed. The deformity may present with varying degrees of midface
17
retrusion, malocclusion, nasal deformity and lip deformity . Secondary and residual
27
dentofacial deformities should be managed by surgical and orthodontic therapy.
Cumulative operative procedures can be done in adolescents (at least 14 years old).
Surgeries performed include pharyngoplasties (38%), alveolar grafting (79%), Abbe flaps
(10%) and orthognathic surgery (13.8%). Patients also undergo lip revisions and secondary
9
nasal operations.
Long-term results of different protocols vary from center to center. For purposes of
documentation and outcome analysis, a standardized video recording to assess cleft surgery
24
outcome has been suggested.
2. Development of interpersonal relationships including the opposite sex
Career planning and goals for higher education
Grade C Recommendation
Emotional effects and psychological aspects of cleft lip and palate deformity and surgery
must be considered. Overgeneralization should be avoided and treatment must be
6
individualized.
REFERENCES
1.

2.
3.
4.
5.

6.
7.

Anteunis, LJ., Brienesse, P., Schrander, JJ., Otoacoustic emissions in screening cleft lip and palate
children for hearing loss- a feasibility study. International Journal of Pediatric Otorhinolaryngology.
1996, Aug, 44(3): 259-66.
BAOMS Cleft lip and palate. http://www.baoms.org.uk/ce/ce_cleft.html
Bergland O., Semb G. Abyholm F.,Elimination of the Residual Alveolar Cleft by Secondary Bone
Grafting and Subsequent Orthodontic Treatment. Cleft Palate Journal. July 1986. 23:3 pp 175-204.
BRISTOL Cleft Lip and Palate Treatment Schedule. http://www.bristol.org.uk/_cleftlip.html
Broen, PA, Moller, KT, Caristrom, J, Doyle, SS., Devers, M. Keenan, KM, Comparison of hearing
histories of children with and without cleft palate. Cleft Palate-Craniofacial Journal 1996, March. 33(2):
127-33.
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21 (1):28-30.

48

CLEFT LIP AND PALATE


0-6 months

Initial evaluation and documentation


Fabrication of intra-oral appliance with monthly modification and feeding
instruction
Otologic evaluation and examination
Vocal play and initial parent counseling on speech
General pediatric evaluation and immunizations
6-12 months

CLAP surgery
Single stage modified Millard with alarplasty
Two flap palatoplasty with optional alveolar bone grafting
Possible VT tube insertion
Intensive speech therapy after single stage CLAP repair
General pediatric follow-up and nutrition evaluation
Dental evaluation and care during primary tooth eruption
1-5 years old

Secondary problem assessment and correction


o Correction of velopharyngeal insufficiency (pharyngoplasty)
o Minor lip revision
o Closure of fistula
Psychiatric evaluation regarding body image issues
General pediatric follow-up
Speech therapy
Articulation and phonetic classes- consonant pronunciation
8-10 years old

Alveolar bone grafting


Orthodontic follow-up
Speech therapy higher level language and speech classes
16-18 years old

Orthognathic Surgery

19 years old
Aesthetic Surgery

49

UP-PGH DEPARTMENT OF OTORHINOLARYNGOLOGY CLINICAL PRACTICE GUIDELINES


TRACHEOSTOMY AND DECANNULATION
SCOPE OF THE PRACTICE GUIDELINE
This clinical practice guideline is meant for use by the Department of Otorhinolaryngology of the
College of Medicine - Philippine General Hospital, University of the Philippines Manila. It covers
tracheostomy and decannulation in children and adults.
OBJECTIVES
The objectives of the guideline are: (1) to discuss the indications and contraindications of
tracheostomy; (2) to identify signs and symptoms of decannulation failure; and (3) to set criteria
for decannulation.
LITERATURE SEARCH
Textbooks in Otorhinolaryngology were reviewed to contribute to the baseline knowledge on
tracheostomy and decannulation, which was later expanded to include journals and publications.
A MEDLINE database search with a Boolean combination tracheostomy or tracheotomy and
decannulation was done. The search was limited to articles involving humans and those
published in English in the last thirty years. Full text articles were obtained when possible. The
search yielded 38 articles divided as follows:
Meta-analysis - 0
Randomized controlled trials - 0
Non-randomized controlled study 1
Well-designed controlled study without randomization - 2
Well-designed descriptive study - 23
Committee report - 12
TRACHEOSTOMY
DEFINITION
Tracheostomy or tracheotomy is an opening surgically created through the neck into the
trachea. A tube is usually placed through this opening (tracheostomy tube) to provide airway, and
3
to allow removal of secretions from the lungs .
Tracheotomy, strictly defined, refers to the incision made in the trachea. Tracheostomy,is the
creation of a stoma through which air may pass to the lungs, by-passing through the upper
airway. Oftentimes both words are used interchangeably to mean a temporary opening in the
4,5,6
anterior neck into the trachea .
PREVALENCE OF TRACHEOSTOMY
In the Department of Otorhinolaryngology of the Philippine General Hospital, there were 107
referrals for tracheostomy in 2002. Ninety-one were adults and more than half (47/91) were over
60 years old. Fifty percent of the 16 pediatric referrals were less than one year old. There were
59 males and 48 females. The most common indications were prolonged intubation secondary to
pneumonia and cerebrovascular disease.
A total of 65 tracheostomies were done on patients admitted at Ward 10, 60 of the patients were
adults. They were commonly due to laryngeal masses followed by oral cavity tumors and anterior
neck masses.
In the years prior to 1960, the incidence of pediatric tracheotomy in the United States was 1 per
7
1000. It has risen to 2.7 per 1000 pediatric admissions .

50

RECOMMENDATIONS ON TRACHEOSTOMY
1. Tracheostomy is recommended in disease conditions with upper and lower airway
patency impairment.
Grade B Recommendation
Current indications for tracheotomy include the group of diseases connected with upper
airways patency impairment, general diseases affecting the patency of lower airways and in
1, 8, 10, 19, 20, 21, 29, 31, 32, 33, 38, 39
patients requiring prolonged intubation and mechanical ventilation
1.1 Upper airways patency impairment
1.1.1 Congenital malformations of the larynx and trachea (congenital infraglottic
laryngeal constriction, laryngomalacia, laryngeal fins, laryngeal cyst,
congenital vocal cord paralysis)
1.1.2 Congenital facial skeleton anomalies including micrognathia and microglossia
1.1.3 Mechanical, thermal, chemical, and iatrogenic trauma of larynx and trachea
(laryngeal tracheal fracture, foreign body wedging or obturating laryngeal
lumen, thermal or corrosive burns, prolonged or traumatic intubation)
1.1.4 Maxillofacial trauma with severe edema of soft tissues and falling back of the
tone
1.1.5 Acute laryngeal edema precluding intubation (inflammatory or allergic)
1.1.6 Tumors of the larynx or trachea (hemangioma, neoplastic)
1.1.7 Bilateral vocal cord paralysis
1.1.8 Laryngeal and tracheal compression by adjacent structures (vascular
anomalies, cervical tumors)
1.2 Respiratory tract patency impairment due to general disease
1.2.1 Retention of secretion in lower airway (balance impairment between secretion
and elimination
1.2.2 Lack of cough reflex
1.2.3 Impaired function of esophageal constrictors and/or vocal folds (saliva or
gastric acid and esophageal contents penetrating the bronchial tree)
1.3 Patients requiring chronic mechanical ventilation
1.3.1 CNS diseases --- long term unconsciousness or coma
1.3.2 Metabolic disorders
1.3.3 Systemic diseases
1.3.4 Chronic diseases of pulmonary tissue
2. Tracheostomy should be performed in both adult and pediatric patients requiring
prolonged intubation. In adults, tracheostomy should be considered after an intubation
period of 7 days. In children, the decision for tracheostomy should be individualized as
they are able to tolerate longer periods of intubation.
Grade B Recommendation
11,37

Prolonged ventilation still remains as the most common indication


. There is some
agreement but no consensus that a period of approximately 7 days is a reasonable time in
adults for a decision to continue intubation or change to a tracheostomy. Clinical observations
have shown that intubation as long as 7 days is followed by complications in 37% of cases.
Several studies have shown that a 7-10 day period for adults is acceptable, after which
prolongation of intubation is accompanied by an increase in incidence of laryngotracheal
11, 37, 39
complications
. Seventeen recent reports suggest that adults can tolerate endotracheal
39
intubation up to two weeks without developing permanent laryngotracheal complications .
Newborns can go for a longer period of time (more than 50 days) without suffering adverse
effects because the risk for subglottic stenosis is low. Other factors such as underlying
15, 16
systemic disease, low birth weight and endotracheal tube size are also influential factors
.
In pediatric patients (more than 1 year old), safe prolonged intubation ranges from 30-60
15
15
days . Their tolerance for prolonged intubation is more like that of neonates than adults .

51

In the last decade, the number of cases of tracheostomy has increased due to the
development of new intensive care units with the use of mechanical ventilation and
12
increasing number of patients needing prolonged ventilation support . There is a noted
increase in frequency of tracheostomies performed for subglottic and tracheal stenosis,
respiratory papillomatosis, caustic alkali ingestion and craniofacial syndromes. Less common
11
4
indications are subglottic hemangioma and laryngeal clefts . Carron et al concluded that
neurological impairment and prolonged ventilation formed the major proportion of the
pediatric tracheostomies, 28% and 26% respectively.

3.

Tracheostomy should be performed with caution in patients with severe bleeding


tendency and unstable cervical spine.
Grade B Recommendation
There are no absolute contraindications to tracheostomy. Severe bleeding tendency and
29,39
unstable cervical spine are relative contraindications
.

4. An evaluation for signs and symptoms of both early and late complications of
tracheostomy, which may occur from the intra-operative period up to decannulation
should be undertaken.
Grade B Recommendation
Complications in the tracheostomy can occur anytime from the intra-operative period up to
decannulation.
Tracheostomy may result in early and late complications

5, 6, 8, 13, 14, 16, 17, 19, 21, 23, 26, 29, 30, 32,33, 34,

35, 38, 39

4.1 Early complications of tracheostomy (less than 7 days)


4.1.1. Subcutaneous, mediastinal, or pleural edema
4.1.2. Subcutaneous emphysema
4.1.3. Aspiration
4.1.4. Cardiac arrest
4.1.5. Recurrent laryngeal nerve paralysis
4.1.6. Acute hemorrhage or bleeding
4.1.7. Sudden saturation decrease and breathing impairment
4.1.8. Infections
4.1.9. Dysphagia
4.1.10 Intraoperative tracheoesophageal fistula
4.1.11 Pneumothorax or pneumomediastinum
4.1.12 Tube obstruction or displaced tracheostomy tube.
4.2 Late complications of tracheostomy. These appear some time after the procedure is
done. These may be life-threatening or may impair decannulation.
4.2.1 Sudden breathing impairment due to lack of tracheostomy tube patency (mucus
plug
4.2.2 Tracheostomy infections
4.2.3 Recurrent lower airway infections
4.2.4 Bleeding, hemorrhage or rupture of innominate artery
4.2.5 Infraglottic stenosis
4.2.6 Tracheal cartilage intussusception above the stoma
4.2.7 Tracheo-esophageal or tracheo-cutaneous fistula after decannulation
4.2.8 Growth of granulation tissue around the stoma and in the trachea
The most frequent early complications are pneumomediastinum, pneumothorax, wound
8, 14, 20, 35
complications like infections and bleeding
. The most frequent causes of
14
tracheostomy-related death are cannula obstruction and accidental decannulation . Early or

52

perioperative complication rates range from 0.1 to 22.9%. Late complications range from 0
32
3
to 37% . Overall, 77% of patients have one or more tracheostomy-related complications .
5

Suprastomal granulation tissue and tracheal stenosis are common late complications
of tracheostomy. When contemplating decannulation, endoscopic evaluation should
be done in patients with prolonged periods of tracheostomy.
Grade B Recommendation
8, 14, 20, 35

Granulation-formation and tracheal stenosis are common late complications


. Their
occurrence necessitates a bronchoscopic examination to ensure that an adequate airway
2, 8, 24
exists
. In one center, a 20-year review of pediatric tracheostomy (1979-99) showed a
19
complication rate of as high as 46%, most commonly granulation tissue formation . In
tracheostomies lasting more than 4 weeks, suprastomal granulation tissue occurs in 50% of
26
pediatric patients .
DECANNULATION
DEFINITION
36
Decannulation refers to the removal of a cannula or the removal of the tracheostomy tube .
25
Decannulation marks the end of the tracheostomy management . It is not uncommon for the
practitioner to encounter problems associated with the decannulation of patients with
tracheostomy.
PREVALENCE OF DECANNULATION FAILURE
The incidence of decannulation problems and failure are often isolated in most tracheostomies
done among adults and their causes vary in each patient. This is not the case in pediatric
38
patients. In a case series done by Midwinter, et al
of 89 tracheostomized children in their
center, they encountered decannulation problems in 17% (15/89) of the patients. An earlier study
28
by Sasaki, et al reported decannulation problems in 91% for children aged 6 months and below
and 23% for those 6 months to 12 years of age. This problem is noted to be significantly higher
9, 28, 38
in the younger age group
.
Failure of decannulation usually occurs within 12 to 36 hours after tube removal. Often, the
underlying reason in such problems is failure to resolve the initial indication for tracheostomy prior
2, 9, 25
to decannulation
. Other reasons include the presence of associated problems in the
respiratory tract like an unresolved subglottic stenosis or the inability to clear secretions.
Decannulation problems may also be related to the tracheostomy procedure itself or its possible
7, 28
sequelae such as tracheal stenosis, granulomas or functional disorders like tracheomalacia
.
Further evaluation by a specialist is necessary when there is failure of decannulation (Please
refer to the algorithm). Endoscopic evaluation is preferred to assess the cause of decannulation
2,6,24
failure
. Several tests can be used to identify causes for decannulation problems like tracheal
stenosis, these include plain tracheal x-ray, tracheal tomogram, MRI, and high-resolution CT
23
scan . For some cases, lateral x-ray including careful laryngoscopic examinations are not only
28
helpful but also essential to successful decannulation in these instances .
Once the tracheostomy tube is removed, close observation is essential in a hospital setting for 24
25
hours as failure of decannulation may still occur . Failure of decannulation may occur as early as
2, 25, 36
12 hours and as late as 36 hours after tube removal
. Observation hospital setting is a must
for at least 24-48 hours for pediatric patients (preferably ICU setting for less than two years of
24
age) . Some even extend up to 7 days especially those whose residences are far from hospital,
24
or centers that can manage decannulation failure and complications .

53

RECOMMENDATIONS FOR DECANNULATION


1. Observe for respiratory distress once tracheostomy tube has been capped, since its
occurrence might indicate decannulation failure.
Grade B Recommendation
When an adult patient cannot maintain adequate ventilation where a fenestrated tracheostomy
18
tube has been capped over a 12 to 24 hour observation period , or when a pediatric patient
24
suffers respiratory distress when the tube has been blocked for 24 hours , then decannulation
failure has occurred. The importance of knowing the indications for decannulation prior to
undergoing the procedure is highlighted in the event that a patient cannot tolerate it, and thus,
there is failure of decannulation. The signs and symptoms to watch out for include inadequate
ventilation and respiratory distress.
In adult tracheostomized patients, capping should be toleratedfor at least 24 hours before the
25
doctors decides for decannulation . Patients are also taught to remove cap themselves if they
experience any breathing difficulty.
For pediatric patients with non-fenetrated tubes, downsizing is initiated. Downsizing means
changing to a smaller size, cuffless tube. A fenestrated tube can be inserted as an alternative if
25
26
okay with primary doctor . The first tube change I always carried out by the doctor . Second
25
downsizing or more may be necessary . In some centers, one may replace the tracheostomy
tube with a tube one size smaller each day until the smallest size usually 3.0 mm. (inside
24
diameter) is used prior to decannulation . Some centers find it helpful to evaluate the subglittic
airway by bronchoscopy prior to decannulation. If the subglottic airway admits a bronchoscope
that is no more than one size smaller than normal for the patients age, decannulation can be
24
proceeded . After downsizing to the smallest tracheostomy tube and tolerated for 24 hours,
capping can be initiated. Once capped patient should be observed for 24 hours. Plugging for at
36
least 24 hours is a must prior to decannulation . A speaker valve may also be used as a
transitioning tool between an open tracheostomy tube and plugging for decannulation. This
allows the child to transition to using the upper airway for exhalation, reintroducing airflow and
36
sensation, and easing the anxiety associated with plugging .
2. Decannulation should be carried out only in a stable patient where the initial indication
for has already been resolved.
Grade B Recommendation
3. There should be no significant compromise of the airway either anatomically or
functionally prior to decannulation.
Grade B Recommendation
4. Endoscopic findings should guide the decision to undergo decannulation. The entire
airway, from the nose to the tracheo-bronchial tree should be evaluated for patency.
Grade B Recommendation
Successful decannulation is critical in tracheostomy management. The following criteria are
recommended to guide the practitioner in this procedure. These indications would be
2, 24, 25, 26, 36,
applicable to both adult and pediatric patients
.
27

4.1. Resolution of condition that required tracheostomy


The indication for tracheostomy should have been addressed prior to decannulation.
The condition or particular diagnosis that required tracheostomy in the patient should be
adequately controlled or effectively treated.
4.2 Patency of the Respiratory Tract
The entire airway from the nose to the tracheobronchial tree should be evaluated for
patency. Each part should be functioning well enough to support the respiratory needs of

54

the patient. A patent respiratory tract will allow respiration to continue adequately through
the glottis while temporary occlusion of the fenestrated tube is done with the finger.
4.3 Stable Patient
The condition of the patient as a whole should be stable. Problems in the other systems
like cardiac, pulmonary, and central nervous system should be improving or unimpaired.
4.4 Protected Airway
The patient must be able to protect the airway.
There should be no significant
compromise of the airway either anatomically or functionally. The patient must have the
ability to clear secretions. In children, there should be no signs of aspiration during
eating or drinking.
4.5 Endoscopic Findings Exhibiting Patent Airway
Endoscopic findings should be near normal or at least the suprastomal airway is patent.
Infrastomal airway evaluation should also be undertaken. This is most helpful for patients
2
who are two years old or younger . Decannulation is recommended once the subglottic
airway admits a bronchoscope that is no more than one size smaller than normal for the
24
patients age .

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Changing Procedure? Annals of Otology, Rhinology, Laryngology, 1999, 108: 635699.
38. Yaremchuk K. Regular tracheostomy tube changes to prevent formation of
granulation tissue. Laryngoscope 2003 Jan;113(1):1-10.
39. Zawadska-Glos L, Chmielik M. Tracheotomy in children-indications and
complications. Department of Pediatric Otorhinolaryngology, The Medical University
of Warsaw, Poland

56

TRACHEOSTOMY

Criteria for
Decannulation
Fulfilled

Maintain Tracheostomy
Tube

N
Y
Trial of Decannulation
Further
evaluation by
specialist
(preferably
with
endoscopic
evaluation)

Tolerated?

N for
Capping
24 hours

Pediatric?

Y
Y
REMOVE TUBE;
Observe for 24
hours in hospital
setting

DOWNSIZE
Further
evaluation by
specialist
(preferably with
endoscopic
evaluation)

Capping for 24
hours

N
REINSERT
TUBE

Tolerated?
Tolerated?

MAINTAIN/ REINSERT
TUBE1

Y
Ff-up
after 7-10
days

REMOVE TUBE
Observe x 24 hrs. in
hospital setting

N
Y
Tolerated
?

Ff-up after 710 days

57

STUDY GROUPS
EAR STUDY GROUP

PLASTIC STUDY GROUP

GENEROSO T. ABES MD MPH (CHAIR)


CHARLOTTE M. CHIONG MD
ABNER L. CHAN MD
TERESA LUISA I. GLORIA-CRUZ MD MHPEd
MARIA RINA T. REYES-QUINTOS MD MCAud
NATHANIEL W. YANG MD

EUTRAPIO S. GUEVARA JR MD
CESAR V. VILLAFUERTE JR MD MHA
FELIX P. NOLASCO MD
JOSE FLORENCIO F. LAPEA JR MA MD
ROBERTO M. PANGAN DMD MD PhD
ARMANDO M. CHIONG JR MD

ERASMO GONZALO DV. LLANES MD


(CHIEF RESIDENT)
CHRISTOPHER MALORRE E. CALAQUIAN MD
HERBERT Q. GUTIERREZ MD
DESIREE B. VANGUARDIA MD
FLORENCE YUL N. SAQUIAN MD

JASON S. GUEVARA MD
MARIO ADRIAN M. ZAFRA MD
MARY APPLE PIE M. GARCIA MD
JOSEPH ROY VINCENT B. UMALI MD

ORAL CAVITY STUDY GROUP

LBEN STUDY GROUP

EDILBERTO M. JOSE MD
JAIME F. FLOR MD
JACOB S. MATUBIS MD
ROMEO L. VILLARTA JR MD MPH
JOSE FLORENCIO F. LAPEA JR MA MD
AGNES N. TIRONA-REMULLA MD

JOSELITO C. JAMIR MD
EUTRAPIO S. GUEVARA JR MD
RENE S. TUAZON MD
JOSE FLORENCIO F. LAPEA JR MA MD
MELFRED L. HERNANDEZ MD MHA

CHRISTINE JOY S. ARQUIZA MD


ERIC T. VINCULADO MD
MICHAEL F. GALICIA MD
FELICIDAD B. MENDOZA MD

VINCENT MARK M. JARDIN MD


ERWIN M. ESLAVA MD
FORTUNA CORAZON A. ABERIN MD
IVY D. PATDU MD

RHINOLOGY STUDY GROUP

TUMOR STUDY GROUP

JOSEFINO G. HERNANDEZ MD
RUZANNE MAGIBA-CARO MD
RAMON ANTONIO B. LOPA MD

MARIANO B. CAPARAS MD
ALFREDO Q.Y. PONTEJOS JR MD
JEANNETTE MARIE S. MATSUO MD
JOSE ROBERTO V. CLARIDAD MD
(ORL ONCOLOGY FELLOW)

JERIEL JOHN C. MAJAM MD


DANILO R. LEGITA MD
PHILIP B. FULLANTE MD
CAMILLE SIDONIE A. ESPINA MD

ERICK G. DUCUT MD
LINA ROSE A. ALCANCES MD MOH
ARSENIO CLARO A. CABUNGCAL MD
LEI-JOAN V. MOLO MD

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