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I. Clinical Question:

Does surface cooling technique improve the level of functioning of

children after traumatic brain injury?

II. Citation

Hypothermia Therapy after Traumatic Brain Injury in Children —

NEJM

III.Study Characteristics

a. Patients Included

The researchers conducted this study at 17 centres in three countries (UK,

France, and Canada). Clients who is in line with being a respondent are those who

are within the age of 1 to 17 years of age who had traumatic brain injuries,

Glasgow Coma Scale of 8 and below during hospital stay, a Computed

Tomography (CT) Scan result that showed an acute brain injury and a need for

mechanical ventilation.

The researchers were able to come up with 327 eligible clients. 69 were

not identified and the parents and guardians were not approached for consent

within 8 hours after injury, 33 had parents or guardians who declined the consent.

The total respondents were 225 (69% of total respondents).

b. Interventions Compared
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Out of the 225 eligible patients, they were divided to two. One has 108

patients and the other has 117 patients.

102 of 108 patients (94%) who were assigned to hypothermia therapy

received the intervention for 24 hours. It took 2.3 hours for the initiation of

cooling, 2.6 hours for the attainment of the target temperature (33.1± 1.2°C for 24

hours), and the mean time to completion of rewarming after 24-hour period at the

target temperature was 18.8 hours.

Meanwhile 114 of the 117 (97%) clients in the normothermia group, a

normal temperature (36.9 ± 0.5°C) was maintained for 24 hours. Patients in this

category were not included in the treatment of hypothermia.

A significant higher proportion in the normothermia group than in the

hypothermia group received hypertonic saline to control intracranial pressure

during the first 24 hours. While In the hypothermia group, clients received

vasoactive drugs for hypotension during rewarming period. But there were no

significant imbalances in the rate at which therapies were used to treat intracranial

hypertension or in the fluid balanced between the groups.

c. Outcomes Monitored

The primary outcome for the study was the proportion of patients who had

an unfavourable outcome – definced as severe disability, persistent vegetative

state or death – at 6 months, which was assessed without knowledge of the

treatment assignments.
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With the use of a scripted telephone interview, a trained psychologist

assessed each client according to six-point Pediatric Cerebral Performance

Category scale ( 1 – normal performance ; 2 – mild disability ; 3 – moderate

disability ; 4 – severe disability ; 5 – persistent vegetative state ; 6 – death). A

score on this scale was also assessed by means of an interview of the parents or

guardians. Measures of intelligence, memory functioning and speed of

information processing were assessed in all of the children who were able to

participate in testing and months after injury ; at these time points, parents were

also involved in the use of an instrument that assesses child’s executive functions.

Blood pressure, intracranial pressure, cointerventions, lengths of stay in

the ICU, and in the rates of adverse effects, including hypotension, infection,

bleeding, arrhythmias and electrolyte imbalance were also recorded.

d. Does the study focus on a Significant Problem in Clinical Practice?

Yes because this can be an efficient, cost effective intervention for

children with traumatic brain injury if proven safe and effective.

IV. Methodology / Design

a. Methodology Used

In 17 centres, the researchers randomly assigned children with severe

traumatic brain injury to either hypothermia therapy (32.5°C for 24 hours)

initiated within 8 hours after injury or to normothermia (37.0°C). The primary

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outcome was the proportion of children who had an unfavourable outcome (i.e.,

severe disability, persistent vegetative state, or death), as assessed on the basis of

the Pediatric Cerebral Performance Category score at 6 months.

b. Design

The study used randomized, controlled trial. Selecting sample patients

without sequence and without bias in 17 centres having a total of 1441 patients.

The study was controlled having eight priority subgroup analyses.

c. Setting

The study was conducted at 17 centres in United Kingdom, France and

Canada.

d. Data sources

James S. Hutchison, M.D., Roxanne E. Ward, B.A., Jacques Lacroix, M.D., Paul

C. Hébert, M.D., M.H.Sc., Marcia A. Barnes, Ph.D., Desmond J. Bohn, M.B.,

Peter B. Dirks, M.D., Steve Doucette, M.Sc., Dean Fergusson, Ph.D., Ronald

Gottesman, M.D., Ari R. Joffe, M.D., Haresh M. Kirpalani, M.B., M.Sc., Philippe

G. Meyer, M.D., Kevin P. Morris, M.D., David Moher, Ph.D., Ram N. Singh,

M.D., and Peter W. Skippen, M.D. for the Hypothermia Pediatric Head Injury

Trial Investigators and the Canadian Critical Care Trials Group (2008, June 5)
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Retrieved from:

http://www.nejm.org/doi/full/10.1056/NEJMoa0706930#t=articleDiscussion

Paul Auerbach, M.D. (2008, August 06). Brain Cooling for Brain Injury.

Retrieved from: http://www.healthline.com/blogs/outdoor_health/2008/08/brain-

cooling-for-brain-injury.html

James Hutchison, MD (2008, June 4). Hypothermia Therapy Not Beneficial for

Children with Brain Injuries.

Retrieved from:

http://www.insidermedicine.com/archives/Hypothermia_Therapy_Not_Beneficial

_for_Children_with_Brain_Injuries_(Interview_with_James_Hutchison_MD)_25

84.aspx

Dr Ian Jenkins (2008, June 5). 'Cooling' child therapy may harm.

Retrieved from: http://news.bbc.co.uk/2/hi/health/7437894.stm

Guy L. Clifton, M.D., Emmy R. Miller, Ph.D., R.N., Sung C. Choi, Ph.D.,

Harvey S. Levin, Ph.D., Stephen McCauley, Ph.D., Kenneth R. Smith, Jr.,

M.D., J. Paul Muizelaar, M.D., Ph.D., Franklin C. Wagner, Jr., M.D., Donald

W. Marion, M.D., Thomas G. Luerssen, M.D., Randall M. Chesnut, M.D.,

and Michael Schwartz, M.D. (2001, February 22). Lack of Effect of Induction
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of Hypothermia after Acute Brain Injury. Retrieved from:

http://www.nejm.org/doi/full/10.1056/NEJM200102223440803#Results=&t=a

rticleMethods

e. Subject Selection

Inclusion Criteria

Included patients in this study are ages and had a traumatic brain

injury, a score on the Glasgow Coma Scale of 8 or less at the scene of the

accident or in the emergency room, a computed tomography scan that

showed an acute brain injury (presence or absence of extradural

hematoma, cerebral edema and midline shift) and a need for mechanical

ventilator.

Exclusion Criteria

Excluded in this study are patients who are 18 years old and above,

those who are screened more than 8 hours after injury and a score on the

Glasgow Coma Scale of greater than 8. Also patients with refractory

shock, suspected brain death, non-accidental injury, prolonged cardiac

arrest at the scene of the accident, high cervical spinal cord injury, severe

neurodevelopment disability before the injury, brain injury due to a

gunshot wound, acute isolated epidural hematoma, or pregnancy.

f. Has the original study been replicated

Yes, there are a lot of journals that replicate the study. The article such as

Journal of Neuroscience Nursing “The use hypothermia as a treatment for

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traumatic brain injury.” This study shown how hypothermia prevent uncoupling of

the metabolic supply demand regulation. The study was just tested with its

reliability and validity and with the result the was gotten the studies that showed

less recovery in IQ scores, attention, and executive functions among children who

sustained severe injuries earlier in childhood, as compared with those who were

injured later in childhoods.

g. What were the risks and benefits of the nursing action/ intervention tested in

the study?

The risk of surface cooling technique decreased the risk of poor outcome,

defined as death, a persistent vegetative state or severe disability. In others study,

the benefits of surface cooling technique is proven that it improves neuorological

function if surface cooling is initiated right after the brain injury, it also decreases

the ICP and increases cerebral perfusion pressure. Surface cooling technique,

therefore, stabilizes the blood-brain barrier and prevents cell death. It also

decreases cerebral metabolic rate, with a resultant decrease in carbon dioxide and

lactate buildup. Moreover, surface cooling technique may prevent uncoupling of

the metabolic supply demand regulation and prevent loss of cerebral

autoregulation (Wright, 2005).

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V. Results of the study

One hundred two of the 108 patients who were assigned to hypothermia

therapy received surface cooling measures. The mean time to initiation of cooling

was 6.3±2.3 hours after injury, the mean time to attainment of the target

temperature range was 3.9±2.6 hours, and the mean time to completion of

rewarming after the 24-hour period at the target temperature was 18.8±14.9 hours.

In 114 of the 117 patients in the normothermia group, a normal temperature

(36.9±0.5°C) was maintained for 24 hours. There were no patient who was

assigned to the normothermia group was treated with hypothermia.

The researchers performed an analysis outcome according to the treatment

received, but they found no major differences from the intention-to-treat analysis.

In a sub-group of 7 year of age or older, the risk of hypothermia therapy is

harmful than with normothermia. There was also a high risk of an unfavorable

outcome with hypothermia therapy in the subgroup that included patients whose

recorded measurements of intracranial pressure were all less than 20 mm Hg.

There were no significant differences in the other subgroups that were analyzed.

Based on the Pediatric Cerebral Performance Category the researches

obtain different scores which indicates an improvement with time after the injury

in both groups; the improvement was greater in the normothermia group than in

the hypothermia group 1, 3, 6, and 12 months after the injury, although the

difference was not significant.

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There were 23 deaths in the hypothermia group, as compared with 14

deaths in the normothermia group. There were no significant differences in the

durations of intracranial pressure monitoring, mechanical ventilation, or stays in

the pediatric ICU or the hospital between the two groups. Intracranial pressures

were lower during the cooling period and higher during the rewarming period in

the hypothermia group, as compared with the normothermia group. The heart rate

was significantly lower in patients who were undergoing hypothermia therapy

than in those in the normothermia group. During rewarming after hypothermia

therapy, researchers noted significantly more episodes of hypotension and lower

mean blood pressures and cerebral perfusion pressures. Hypotension was treated

with boluses of intravenous fluids and vasopressors according to the study

treatment guidelines.

The researchers also performed a neuropsychological follow-up. Patients

were not assessed if they were too young to participate in testing (generally,

younger than 5 years of age) or had severe functional or physical impairment that

made assessment impossible, or if their parents or guardians could not be

contacted or refused follow-up. Scores on assessments of long-term visual

memory were significantly worse in the hypothermia group than in the

normothermia group 12 months after injury. There were no other differences in

neuropsychological outcomes between the groups.

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Based on the data shown the researcher’s stated that they did not detect

any benefit in their subgroup of patients who were treated by the hypothermia

therapy. In fact, they observed a trend toward increased mortality in the said

group. But they concluded that hypothermia therapy with the adjustment of

degree and depth according to intracranial pressure may be of benefit as a therapy

for refractory intracranial hypertension in many children with severe traumatic

brain injury. They also found no evidence that the cointerventions used such as

the management if intracranial pressure and other aspects of care contributed to

the failure of the hypothermia therapy.

VI. Author’s Conclusion / Recommendation

1. What contribution to the client's health status does the nursing

action/intervention make?

There is no proven benefit to the client’s health status since the risk of

unfavourable outcomes is higher in hypothermic clients than those patients with

normal temperature. However, if the client survived the injury then there is a

greater chance of favourable outcomes such as responding well to standard

measures of ICP control.

Contribution to client’s health status is as follows hypotension, no improvement

in functional outcomes, pneumonia more prone to infection and increased

mortality as some of its negative effects.

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However, in some articles it is proven that it improves neurological function if

surface cooling measure is initiated right after the brain injury; it also decreases

the ICP and increases cerebral perfusion pressure.

2. What overall contribution to nursing knowledge does the study make?

Although a recommendation cannot be done as for revising the practice, it

should be more explored; a recommendation on an earlier implementation or

prolonged surface cooling measure may improve and change the outcome in

children with severe traumatic brain injury.

VII. Applicability

1. Does the study provide a direct enough answer to your clinical question in

terms of type of patients, intervention and outcome?

Yes, because the patients included in the study were clients aging from 1-

17 years old who experienced traumatic brain injuries, however, the results

showed that hypothermia (surface cooling measures) therapy used on these types

of patients were not effective in improving their level of functioning 6 months

after the intervention. Death rate and risk of unfavourable outcome was higher

among patients who underwent hypothermia therapy as compared to those in the

normothermia group.

2. Is it feasible to carry out the nursing action in the real world?

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Yes, nurses can easily carry out the intervention in the real world;

however, it would not offer any significant benefit to the said patients in

improving their condition. Therefore, this kind of therapy is not acceptable for

treating severe head injury among children.

VIII. Reviewer’s Conclusion / Commentary

The researchers concluded that the use of this hypothermia (Surface

Cooling Therapy) protocol is not a guarantee as a treatment of severe head injury

in children. There is an increased mortality rate in hypothermia group and found

no evidence of significant benefits with respect to any secondary outcome.

Further research may expound whether earlier implementation of this therapy

would improve the outcome in children with severe traumatic brain injury.

IX. Evaluating Nursing Care Practices

a. Acceptability

Hypothermia therapy is not safe because does not improve the level of

functioning of children with traumatic brain injury, thus it causes severe

disability, a persisted vegetables state, or even death.

b. Competence of the care provider

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Considering that there is an increased in mortality in the hypothermia

group and there is no benefit on functional and neuropsychological outcomes, we

can infer that health care providers have not met the needs of the client and were

not competent enough in giving and providing care for those clients who have

traumatic brain injury.

c. Acceptability

This intervention is not acceptable because it causes higher mortality rate.

Improvement of functional level of children with traumatic brain injury is not yet

proven.

d .Effective

Hypothermia therapy is not significantly effective among children with

traumatic brain injury because it increases their rate of mortality.

e. Appropriateness

Hypothermia therapy is not appropriate because of the complications such

as severe disability, a vegetative state and even death that brought by this

intervention.

f. Efficiency

The study is efficient but lacks benefits and strengths. Some of which are

helpful information presented regarding hypothermia therapy which serves as

warnings and precautions regarding its negative effects and the special and
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specific cases of patients presented which served as guide and insight concerning

the reality behind the intervention.

g. Accessibility

It is accessible in other countries such as United Kingdom, Canada and

France but not in the Philippines. Although the actual intervention is not available

in the Philippines, the information regarding procedure is available in the World

Wide Web.