Running head: SEVERE TRAUMATIC BRAIN INJURY
The Role of Hypothermia in the Management of Severe Traumatic Brain Injury
Jessica Gutsjo, Tracey Sapp, Marilyn Thomas
Wright State University
NUR 788
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SEVERE TRAUMATIC BRAIN INJURY
Table of Contents
Abstract……………………………………………………………………………………..3
Introduction Statement of the Problem………………………………………………..4-6
Planning the Practice Change Team………………………………………………….6-7
Critical Appraisal of the Evidence……………………………………………………7-15
Planning a Pilot Test of the Change………………………………………………..15-20
Model…………………………………………………………......15-16
Specific Aims/Setting……………………………………………16-17
Support………………………………………………………………..17
Population…………………………………………………………….17
Intervention…………………………………………………………...18
Resistance……………………………………………………........…18
Special Accommodations……………………………………………19
Timetable………………………………………………………….19-20
Strategies for Support………………………………………………..20
Evaluation……………………………………………………………………………..20-23
Budget…………………………………………………………………………………23-24
References…………………………………………………………………………...25-28
Appendix A…………………………………………………………………………..29-41
Synthesis of the Level of Evidence Table
Appendix B………………………………………………………………………………42
Levels and Types of Evidence Table
Appendix C………………………………………………………………………………43
Quality of Evidence Table
Appendix D………………………………………………………………………………44
Timeline
Appendix E………………………………………………………………………………45
Budget
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Abstract
Severe traumatic brain injury (TBI) is a significant national, state and local public health
problem that has attracted the attention of national and state level health promotion
agencies such as Healthy People 2020 and the Brain Injury Association of Ohio. The
American Association of Neuroscience Nurses adult severe TBI clinical practice
guideline (CPG) classifies hypothermia as a level II recommendation reserved for use
as a second tier intervention. Standard protocol in the Intensive Care Unit (ICU) at the
clinical practice site endorses the use of cooling blankets to induce hypothermia for
patients with resistant or refractory increased intracranial pressures. However, new
research highlighting the effectiveness of induced hypothermia to treat other fatal
illnesses led the authors to investigate the following: In ICU patients with acute severe
TBI, how does the use of induced hypothermia compared to maintenance of
normothermia influence intracranial pressure (ICP) readings and result in a favorable
Glasgow Outcome Score (GOS) during first 72 hours post injury and at 3, 6, and 12
month intervals post injury. An extensive literature search concluded inconsistent and
contradictory evidence that lacked strong support for hypothermia as a tier one
intervention; thus, the authors validated the clinical practice setting’s compliance with
current recommended cooling therapy guidelines. The authors also identified a shortfall
within the clinical practice site. Currently, the clinical location does not collect data on
patients receiving hypothermia treatment nor do they collect data on neurological
outcomes following discharge from the ICU. The authors believe the clinical practice site
would benefit from employing an Advance Practice Nurse (APN), grounded in evidence
based practice (EBP), to examine the effectiveness of facility practices, gather and
manage patient data and follow-up neurological outcome measures, explore other
treatment protocols such as intravascular cooling and encourage ICU nurses to
examine current protocols using evidence-based research.
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Evidence-Based Practice Change Proposal
Introduction Statement of the Problem
Healthy People (HP) 2020 (2012) create goals to “attain high-quality, longer lives
free of preventable disease, disability, injury, and premature death” (About healthy
people section, para. 2). One of the HP 2020 objectives is Injury and Violence
Prevention with a subtopic of Traumatic Brain Injury (TBI). There are three goals that
HP 2020 has identified for TBI with the goal of a 10% decrease by the year 2020. These
goals include: reduce fatal and nonfatal TBIs, reduce hospitalization for nonfatal TBIs,
and reduce emergency department visits for nonfatal TBIs. Specifically, HP 2020’s goal
is to reduce fatal TBIs to 15.6 deaths per 100,000 from 17.3 deaths per 100,000 in
2007, reduce hospitalization for nonfatal TBIs to 77.0 hospitalizations per 100,000 from
the 85.6 hospitalizations baseline in 2007, and to reduce emergency department visits
for nonfatal TBIs to 366.5 emergency department visits per 100,000 from the 407.2
baseline in 2007.
National, state and local statistical data highlight the significance of this public
health problem. On the national level, between the years of 2002 and 2006, an
estimated 1.7 million people sustained a TBI annually. Of the number of individuals
previously mentioned, 52,000 died, 275,000 were hospitalized, and 1.365 million (nearly
80%), are treated and released from emergency departments. About 75% of TBIs that
occur each year are concussions or other forms of mild-TBIs. For the purposes of this
evidence-based practice change proposal (EBPCP), the other 25% of non-mild TBIs will
be the focus (CDC, 2010). As of 2000, direct medical costs and indirect costs of TBI (i.e.
productivity) totaled an estimated $60 billion in the United States (U.S.). Falls are the
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leading cause of TBI; however, motor vehicle accidents (MVA) are the leading cause of
TBI-related deaths with rates being the highest for adults aged 20 to 24 years. Other
high prevalent categories for causes of TBIs within the adult population include
assaults, being struck by an object, and TBI of unknown causes (CDC, 2010). Locally,
the Brain Injury Association of Ohio (BIAOH) calculated a total of 118,760 of 11,530,120
Ohio residents (1.03%) living with a TBI. Furthermore, 5,512 of 535,153 (1.03%)
Montgomery County residents have sustained a TBI (BIAOH, 2011).
The problem of interest for the proposed practice change is TBI which is defined
as an “alteration in brain function, or other evidence of brain pathology, caused by an
external force” (Brain Injury Association of America, 2011, definition section, para. 2).
The Centers for Disease Control and Prevention (CDC) defines a TBI as being “caused
by a bump, blow, or jolt to the head or a penetrating head injury that disrupts the normal
function of the brain” (CDC, 2010, para. 1). Traumatic Brain Injury.com (2006) classifies
a moderate brain injury as a brain injury resulting in a loss of consciousness for 20
minutes to 6 hours and a Glasgow Coma Scale of 9 to 12. A severe brain injury is
classified as a brain injury resulting in a loss of consciousness of greater than 6 hours
and a Glasgow Coma Scale of 3 to 8.
In the hospital Intensive Care Unit (ICU) environment, an important component
for decreasing TBI mortality rates is effective management of intracranial hypertension.
Uncontrolled prolonged increases in ICP can lead to fatal brain anoxic injures. The
Agency for Healthcare Research and Quality (AHRQ) and the American Association of
Neuroscience Nurses (AANN) has identified multiple nursing interventions that are
recommended in order to decrease and/or to prevent an increase in an individual’s
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intracranial pressure (ICP). These recommendations include elevating the head of bed
to 30 degrees, providing sedation, administering osmotic diuretics as needed, and
draining cerebral spinal fluid. The AANN classifies moderate hypothermia as a level II,
controversial recommendation for the treatment of refractory intracranial hypertension.
However, new findings propose there is a greater decrease in mortality risk when
hypothermic temperatures are sustained for more than 48 hours (Brain Trauma
Foundation [BTF], 2010).
To manage the ICP of severe TBI patients, standard protocol in the ICU at the
clinical practice site proposed for this EBPCP change includes: use of sedation,
promoting normothermia, loosening of the cervical collar and maintaining the head of
bed at 30 degrees. The use of hypertonic solutions and cooling blankets (to induce
hypothermia) are reserved for patients with resistant or refractory increased intracranial
pressures. In light of new research highlighting the effectiveness of induced
hypothermia in other acutely ill patients, the team questions whether these research
findings provide enough evidence to cause the clinical practice site to reprioritize its
protocol in the management of TBI. This knowledge trigger lead to the question: In
Intensive Care Unit (ICU) patients with acute severe Traumatic Brain Injury (TBI) (P),
how does the use of induced hypothermia (I) compared to maintenance of
normothermia (C) influence ICP readings and result in a favorable Glasgow Outcome
Score (GOS) (O) during first 72 hours post injury and at 3, 6, and 12 month intervals
post injury (T).
Planning the Practice Change Team
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For this practice change a multi-disciplinary team will be needed. The practice
change team should include an ICU Registered Nurse (RN), the ICU RN administrator,
the ICU medical director and/or a Neurosurgeon, and an Advanced Practice Nurse
(APN). The APN’s salary will be prorated for two days per/week to oversee the
proposed practice change from the onset to conclusion, and to maintain the integrity of
data collection and data analysis/interpretation. The ICU RN will be responsible for
disseminating information to peers and to provide training and oversight as needed. The
ICU RN will support the APN’s efforts and provide assistance as needed for research,
data collection, data analysis/interpretation. The ICU RN administrator will act as a
liaison between the APN and hospital administrators when needed as well as provide
adequate flexibility in the schedule to carry out the practice change. The ICU medical
director and/or Neurosurgeon will provide medical expertise and guidance to the APN.
The setting for the proposed practice change will be a Level-1 trauma center
centrally located in Montgomery County which is the fifth highest county in Ohio with
TBIs behind, Cuyahoga (13,185), Franklin (11,846), Hamilton (8,807), and Summit
(5,587) counties. The key informants within the practice site include hospital
administration, nursing management, physicians and staff of the ICU.
Agencies outside of the practice site will be included, but will not be involved in
direct service delivery of patients. Examples include: area rehabilitation facilities, the
BIAOH, the AANN, the BTF, and the AHRQ. These agencies should be included
because the practice change is patient-focused, and these agencies have indirect
interaction with the patient.
Critical Appraisal of Evidence
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Multiple sources of evidence have contributed to the development of the
proposed practice change, such as Cochrane review, meta-analyses, control trials with
randomization, systematic reviews, cohort studies, and clinical practice guidelines
(CPG). The collective evidence was obtained following an extensive literature review
using the Cochrane database, CINAHL, PubMed, MEDLINE, AHQR, AANN, and the
BTF. The extensive research was derived from the following key words: traumatic brain
injury, head trauma, head injury, hypothermia, induced hypothermia, cooling, and
normothermia. Articles were selected based upon their applicability to the topic under
investigation. Seventy-four articles were reviewed; however, most (n = 65) were
excluded or discarded because they were greater than 10 years old, they did not
completely fit the criteria for the proposed practice change or they were studies
conducted on the pediatric population, were not in English, or were opinion and/or
commentary articles (see Appendices A, B and C for synthesis of the level of evidence,
levels and types of evidence and quality of evidence tables).
Zhao, Zhang, and Wang (2011) conducted a single study to examine the
association between blood glucose or lactate and the outcomes of severe TBI, and to
evaluate the effect of mild hypothermia therapy on glucose and lactate levels. Eightyone patients with TBI were randomly divided into normothermia and mild hypothermia
groups. Body temperature was maintained at 32.7oC for 72 hours in the hypothermia
group. Arterial blood glucose and lactic acid where measured before and after
hypothermia therapy. The GOS score was assessed three months after treatment. The
results showed that hyperglycemia after TBI was associated with poor clinical
outcomes, but blood lactate predictive values required further investigation.
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Hypothermia treatment was found to improve neurologic outcomes, and reduction in
blood glucose may have been partially responsible for the improved outcomes.
Saxena and colleagues (2008) conducted a systematic review with the aims of
answering three specific questions: (a) modest cooling therapies reduce the risk of a
poor outcome after TBI, (b) modest cooling therapies increase the risk of intracranial
and extracranial bleeding, and (c) modest cooling therapies increase the risk of
pneumonia or other serious infections. The authors were unable to find any randomized
control trials or controlled clinical trials that could be included in the review; therefore,
could not recommend the use of interventions to reduce body temperature following TBI
because there is no satisfactory research that shows it to be effective and safe.
In 2008, the AANN published CPGs for the treatment of TBI. The AANN
conducts a targeted review of newly published literature annually. The reviews support
the December 2009 and December 2011 revisions of the CPG. The AANN
recommendation for practice of TBI identifies the induction of mild hypothermia to
decrease ICP as a level 2 recommendation. They also stress the importance for the
neuroscience ICU nurse to be aware of the potential complications of hypothermia
(pneumonia, electrolyte disturbances, cardiac arrhythmias, shivering, hiccups, and
increased ICU stay) and to be well-versed in treatment protocols.
Clifton and colleagues (2011) conducted a randomized-controlled trial (RCT) with
the aims of answering one specific hypothesis: does the initiation of hypothermia reduce
the amount of patients with poor outcomes at 6 months following injury compared to
normothermia. The trial consisted of 97 patients (52 patients who received the
hypothermia treatment and 45 patients who maintained their normothermia). The patient
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must have a non-penetrating severe brain injury, be 16-45 years of age and not
responsive to instructions upon admission. The method for inducing hypothermia is by
the following: 35°C then cooled to 33°C for 48 hours and then gradually rewarmed. The
principal outcome of measurement was the GOS at 3 months and 6 months after injury.
The disability rating scale was measured at 2 weeks, 4 weeks, 3 months, and 6 months
after injury. In conclusion, there was no considerable distinction in outcomes in patients
treated with hypothermia compared to those treated with normothermia; however,
patients in the hypothermia group had a greater frequency of episodes of increased ICP
in comparison to those in the normothermia group.
Henderson and colleagues’ (2003) systematic review and meta-analysis
examined the evidence on the effects of hypothermia on the management of TBI
interventions to improve morality rates and GOSs. Eight RCTs were reviewed. The
systematic review and meta-analysis provided strong evidence that there is no
considerable benefit between patients who maintained normothermia in comparison to
patients who received hypothermia in regards to morality rates. Conversely, four of the
eight studies found a positive effect of hypothermia on GOS outcomes; however, two of
the studies had a CI >1. In conclusion, the use of hypothermia was not strongly
supported by the evidence.
Sydenham and colleagues (2009) conducted a Cochrane review to examine if
the use of mild hypothermia reduced the risk of death (mortality rate), vegetative state,
or severe disability (known as unfavorable outcomes), and if the risk of pneumonia was
increased. The review focused on 23 recent RCTs of 1614 patients with any closed
traumatic head injury requiring hospitalization. The review provided strong evidence that
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there is no considerable benefit in the use of hypothermia in the treatment of head
injuries. However, it is stated that hypothermia may be effective in reducing the
possibility of death and unfavorable outcomes for traumatic head injured patients, but
this was only proven in low quality trails. Conversely, the higher quality trials did not find
a benefit in decreasing the likelihood of head with hypothermia.
Peterson, Carson & Carney (2008) conducted a meta-analysis on 8 RCTs to
evaluate the outcome effectiveness of hypothermia on mortality and favorable
neurological response. The pooled study results were unable to produce a statistically
significant single effect measure for either outcome when looking at the whole
population. However, subgroup analyses comparing hypothermia with conventional TBI
treatment confirmed hypothermia offered the greatest benefit to decrease mortality risk
when cooling was maintained for more than 48 hours and when barbiturate medication
was not co-administered with hypothermia therapy. Subgroup analyses also showed
use of hypothermia therapy had an increased likelihood of a favorable neurological
outcome when a) hypothermia was maintained for greater than 48 hours; b) barbiturate
therapy was not a component of ICP management and c) when trials followed patients
for a year or longer after initial injury. These study results are similar to findings reported
in a 2003 systematic review performed by McIntyre and colleagues.
McIntyre et al. (2003) systematically reviewed 12 RCTs of varying
methodological quality. They observed a significant reduction in the risk of death and
poor neurologic outcome in favor of therapeutic hypothermia compared with
normothermia; however, the results should be interpreted with some caution because of
the small number of high-quality RCTs. After subgroup analysis, their results suggest
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the greatest clinical benefit may be derived when patients are cooled to a target
temperature of 32oC to 33oC for greater than 48 hours, and then rewarmed within 24
hours after discontinuation of hypothermia. The researchers also identified the potential
for arrhythmias and increased risk for infection associated with hypothermia therapy;
therefore, hypothermia therapy should be used with caution in certain patient
populations.
Puccio et al. (2009) used a cohort study design to assess the impact of
normothermia on fever incidence and intracranial pressure over a 3 day period. The
study findings suggest induced normothermia using an intravascular cooling catheter
(intervention group) verses anti-pyretics and cooling blankets (control group) is effective
in reducing fever burden and provides an effective means to reduce ICP readings.
Although core body temperatures in the intervention group never reached hypothermic
ranges, the study validated the efficacy of intravascular cooling over conventional
cooling techniques; ultimately endorsing the use of an intravascular cooling catheter as
the best method for controlling core body temperature.
Conclusions regarding the use of induced hypothermia for TBI management are
inconsistent and the intervention is not strongly supported by the available evidence.
Five Level 1 systematic reviews analyzed numerous RCTs that explored the use of
induced hypothermia and each review concluded a lack of strong clinical evidence
endorsing the intervention. Four of the five reviews reported that hypothermia may
provide some benefit in outcome measures but these results were either observed in a
particular subset of the population or the results were obtained from low quality trials.
The authors of the fifth systematic review, performed in 2008, were unable to find RCTs
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that statistically showed hypothermia to be safe and effective. Therefore, the authors
could not recommend its use. Furthermore, the reviewers identified situations when
hypothermia therapy was detrimental to neurological outcomes or linked to patient
complications, such as arrhythmias, pneumonia, electrolyte disturbances, and
hypotension. Two critical appraisals were performed on single study RCTs. Both study
design results were critically appraised as valid; however, the outcome measures
reported were contradictory. One study concluded a statistically insignificant distinction
between intervention and control groups, while the second RCT found hypothermia to
improve neurological outcomes.
Possible explanations for incongruent study results include: a) divergent
hypothermia treatment protocols; b) inconsistencies in the quality of methodological
designs and c) different outcome measures, assessed at varying intervals. Examples of
divergent hypothermia treatment protocols include differences in the amount of time
lapsed from moment of injury to induction of hypothermia. In some studies, hypothermia
was induced immediately upon admission while other studies waited up to 20 hours
post-injury to induce cooling. Secondly, some study protocols dichotomized
hypothermia into mild verses moderate temperature categories while others did not.
Treatment protocols also differed in the length of time required to reach the desired
hypothermic temperature. Target hypothermia temperature goals ranged from 30oC to
35oC and cooling duration varied from 1 – 14 days. Lastly, co-interventions and/or
control for confounding variables differed. Highlights of inter-study treatment
irregularities co-administered with hypothermic (cooling) therapy include intermittent use
of intravascular drainage devices, concomitant use of neuromuscular blockade
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medications and/or barbiturates and altering use of Mannitol or other osmotic diuretics
to control intracranial pressures.
Authors of the systematic reviews reported a limited ability to assess the overall
methodological quality of their selected trials due to incomplete reporting of methods of
randomization, allocation concealment and blinding of the outcome assessment to
researchers. Due to the limited reporting, only a small number of trials received a high
methodological grade, thus reducing the strength of evidence revealed from aggregate
study analysis. Finally, differences in outcome measures and follow-up duration
contribute to study inconsistencies. Some studies used mortality as its single outcome
measure. Other studies graded neurological outcomes according to the GOS at
intervals ranging from 5 days to 24 months following hypothermia therapy. One study
graded neurological outcome based on blood glucose and lactate levels. Although some
studies identify hypothermia as effective in some circumstances, researchers must
conduct more high quality methodological studies with consistent treatment protocols
and outcome measures studied at congruent intervals before the practice of
hypothermia can be widely accepted as a standard of practice. Based on the varying
conclusions, hypothermia therapy remains a controversial intervention for TBI
management.
Current AANN CPGs identify moderate hypothermia as a level two
recommendation. The clinical practice site is compliant with current guidelines by only
initiating a hypothermia protocol for TBI patients who have resistant or refractory
increased intracranial pressures. The practice site’s current method of cooling includes
use of an external cooling blanket. Research performed by Puccio et al. (2009) showed
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intravascular cooling is the best method for controlling core body temperature as it lacks
the negative side effects associated with external cooling devices.
Planning a Pilot Test of the Change
Model.
There are numerous models that have been developed to systematically guide
the implementation of EBP. Two models, The Iowa Model of EBP to Promote Quality
Care and The Model for EBP Change (Melnyk & Fineout-Overholt, 2011), were
considered to guide this change proposal because both address clinical based
decisions that affect patient outcomes.
The Iowa model was chosen particularly because of its basis of guiding the user
through problem-solving steps in the scientific process and its ease of use and
applicability to multidisciplinary teams. The model encourages identification of triggers
(problem-focused vs. knowledge-focused) that come from questioning current practice.
Problem-focused triggers are derived from existing data that encourage opportunity for
improvement. Knowledge-focused triggers are derived from scientific knowledge that
leads practitioners to question current practice standards (Melnyk & Fineout-Overholt,
2011).
As soon as there is commitment to addressing the proposed change, a team is
formed which ideally consists of stakeholders who will develop, implement, and
evaluate the practice change. Initially, the team selects, reviews, critiques, and
synthesizes research evidence found in current literature. Once evidence is sufficient, a
practice change is piloted to determine the feasibility and effectiveness of the change in
clinical care. Upon completion of the pilot, the evaluation process comparing pre-pilot
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and post-pilot data will determine the success of the pilot, effectiveness of the protocol,
and the need for modification. Positive outcomes lead to rollout and implementation of
the practice followed by continuous monitoring of outcomes. If the practice is not ready
for rollout and implementation, process improvement monitoring is needed to ensure
high-quality patient care. Dissemination of results is the final and important step in the
process to insure promotion of EBPs within the healthcare system (Melnyk & FineoutOverholt, 2011).
Unique to the Iowa model are several feedback loops which highlight the
nonlinear nature of EBP. The feedback loops allow the user to analyze, evaluate, and
modify based on the evaluative data of both process and outcome indicators (Melnyk &
Fineout-Overholt, 2011). The knowledge-focused trigger instigating the proposed
EBPCP is the recent compelling evidence that permissive hypothermia is effective in
reducing ICPs and GOS; therefore, the Iowa model will be useful in guiding the
multidisciplinary healthcare team through the problem-solving process.
Specific aim/setting.
The specific aim of induced hypothermia/normothermia is to reduce the amount
and severity of individuals who are disabled and/or reside in a vegetative state from TBI
and to reduce the mortality and the direct/indirect cost associated with TBI. The clinical
setting is a 23-bed Surgical-Trauma ICU at a moderately sized Level-1 trauma center
located in the Midwest. The trauma center employs a number of neurosurgeons and
interventional radiologists who are capable for caring such individuals. The team has
identified that the clinical practice site is following current recommendations from the
AANN; however, they lack the expertise of an APN grounded in EBP to review the
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evidence and collect data supporting the use of hypothermia in the facility. The clinical
practice site would benefit if an APN were employed for the purpose of managing such
data and examining the effectiveness of the current practice within the facility. The APN
would work two days per week. The days would be dedicated to examining the
effectiveness of the clinical practice site’s current protocol by gathering ICP readings
from medical records and GOSs from rehabilitation facilities. In addition, the APN would
explore other treatment protocols such as intravascular cooling and encourage ICU RNs
to examine current protocols using EBP.
Support.
Current practice is supported by ICU RNs, administrators, and physicians
throughout the clinical setting. It is unspecified whether hiring an APN to examine the
management of TBI within the facility would be supported by ICU RNs, administrators,
and physicians at this moderately sized facility.
Population.
In order to validate the effectiveness of the current protocol at the clinical practice
site the APN will recruit patients over a six month period. The patient population will
include adults aged 18-65 with severe TBI sustained from a MVA, ATV accident, fall, or
assault. Based on current literature from 2001-2011, the average number of patients
recommended for this pilot change is 50. Patients will be recruited over a six-month time
period. Once the target of 50 patients is reached, recruitment will end. Adult patients
between the ages of 18 and 65, who have sustained injuries as a result of a MVA, ATV
accident, fall, or assault and are unresponsive at the time of arrival will be included.
Pediatric patients will be excluded.
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Intervention.
Although the EBPCP team was unable to find compelling evidence that
hypothermia is more beneficial than normothermia in TBI outcomes, the team was able
to validate that the clinical practice setting is currently following the recommended
cooling therapy guidelines for TBI patients. The clinical practice setting currently follows
AANNs level II recommendation of induced hypothermia by providing cooling therapies
to severe TBI patients who have resistant or refractory increased intracranial pressures.
Initial cooling methods include: reducing the room temperature, utilization of a fan,
applying ice packs and administering anti-pyretics when fever is present. The addition of
an external cooling blanket, such as the Blanketrol® is used when the patient is
experiencing refractory ICP that is not being controlled, below 20 mm Hg. The extensive
review of literature validated the current practice; however, introduced intravascular
cooling which is shown to reduce temperature more effectively without the negative side
effects associated with external devices.
Resistance.
Incorporating an APN into the ICU to conduct the EBP may meet resistance. ICU
RNs may be fearful that the APN will create more work for them or introduce new
concepts that may bring more technology which may increase their workload.
Administrators may view the projected cost of hiring an APN as unnecessary and
possibly encourage ICU RNs to take on the burden of examining the current protocol.
Physicians may view their protocols as standard and discourage change. They may
also feel that the physician is the clinical expertise; therefore, discourage the hiring of an
APN.
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Special accommodations.
The current protocol requires the use of the Blanketrol® external cooling
blanket which is used at the clinical practice site. This external device requires minimal
special accommodations. The Blanketrol ® requires distilled/sterile water. De-ionized
water and alcohol cannot be used. A physician’s order is required. The ICU RN is
required to assess the patient’s temperature and skin condition frequently in areas of
direct contact. The patient is at risk for skin injury such as burns, frostbite, pressure
wounds, and skin tears due to the temperature of the blanket. In addition, the Blanketrol
® requires training on behalf of the ICU RN in order to set up and sustain the
equipment. The Blanketrol ® is approximately 1.5’ W x 1.5’ D x 3’ H. It requires a
moderate amount of space at the patient’s bedside. This can be a burden to the ICU
RNs as they are required to maneuver around the equipment to care for the patient.
The clinical practice setting will be required to provide special accommodations
for the APN. Suitable private office space with a desk, chair, computer, printer, and
locking file cabinets are imperative to provide adequate work space as well as integrity
of the data collected.
Timetable.
The clinical practice site does not currently collect data on patients receiving
hypothermia treatment nor do they collect data on GOS following discharge from the
ICU. This shortfall could be fulfilled by employing an APN grounded in the principles of
EBP. The APN would work two days per week to examine the effectiveness of the
clinical practice site’s current TBI protocol, collect data on inpatient ICP readings from
medical records and GOSs from rehabilitation facilities, explore other treatment
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protocols such as intravascular cooling and encourage ICU RNs to examine current
protocols using EBP. Total integration of the APN would take approximately 6 months
(see Appendix D for timeline).
Strategies for support.
Strategies used to encourage others to support the practice change include:
planning educational sessions during work hours to allow individuals the opportunity to
ask questions or clarify misconceptions that may currently exist with the current
practice. Individual personality styles should be identified. Those determined to be
drivers will be given the opportunity to lead the team. The socially oriented, motivational,
supportive and steady staff members will be provided with instructions on
implementation of the practice change. Contemplators will be provided with education
based on the most current literature. The strategic plan for the organization including
benefits or strengths of the current protocol will be shared. A progress report will be
posted on convenient and visible sites in the agency for interested staff to review.
Suggestions will be solicited for success of the proposed practice change and all input
will be evaluated by the team. Recognition will be given to all involved in the proposal.
Typically with EBPCPs, the patient’s satisfaction is taken into consideration for
efficacy of the intervention and patients receive remuneration for participating in a study.
However; due to the severity of the patient’s illness and unconscious state, the ICU
would be unable to acquire patient satisfaction data in regard to ICU interventions.
Additionally, patient remuneration is not required because patient data will be acquired
during their hospitalization.
Evaluation
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The potential pilot study outcomes will be measured in a short- and long-term
approach. The short-term outcomes will be measured by the ICU RN on a continuous
and periodic basis. The two short-term outcomes to be measured will be the continuous
ICP value and an every four hour Glasgow Coma Scale (GCS). The goal for the
continuous ICP value will be less than 20 mm Hg, the same value that our clinical
practice site uses as a guideline. The ICP value can be monitored efficiently by the ICU
RN. The ICP device is calibrated to the monitor at the time of set up. The pilot study will
also assess GOS (long-term outcome). The GOS will be assessed at the time of
discharge and again at 3 and 6 month intervals and again at the one year mark post
discharge. This will be evaluated and documented by the APN in order to ensure
consistency. Human subject concerns for existing or new educational pilot studies are
expedited by the Institutional Review Board (IRB).
For this study, the quantitative data obtained will be described and analyzed
using descriptive and inferential statistics. Data retrieved will include: continuous ICP
values, patient temperatures, GCS, and the GOS at 3, 6, and 12 months postdischarge. The data retrieved will be entered into the Statistical Package for the Social
Sciences (SPSS) program. The quantitative data obtained from the SPSS will be
analyzed further by using t-tests to interpret the data for inferential statistics. The
calculation of t can be calculated in SPSS as well. According to Polit and Beck, a t-test
can be used when the sample is dependent (e.g., induced hypothermia and
maintenance of normothermia values). This is often used to calculate the significance of
calculated differences between the means of two samples. It is expected to produce a
significant dependent t-test result.
SEVERE TRAUMATIC BRAIN INJURY
22
Reliability, the measure of how stable, dependable, trustworthy, and consistent a
test is in measuring the same thing each time; and content validity will be ensured due
to the items on the values representing the entire range of possible items the test
should cover. Reliability and validity will be ensured due to the ICP monitor being
calibrated prior every shift. Patient temperatures will be accurate due to an internal
temperature monitor. ICU RNs at the clinical practice site are trained on the GCS,
therefore, GCS reliability will be ensured. All GOS values will be obtained by the APN to
ensure reliability.
The strategy for evaluating the effects of the practice change is the Donabedian
Framework. The Donabedian Framework consists of four areas of interest; the
structure, process, outcomes, and impact of the change. The structure aspect of the
Donabedian Framework encompasses the social and physical resources of a facility
and if the facility is capable to support the proposed EBPCP. The process characteristic
of the Donabedian Framework includes a number of questions: a) what will occur
during the EBPCP, b) who was involved, c) how many people will be reached, and d)
what factors will contribute to the results, to name a few. The outcome feature of the
Donabedian Framework encompasses the effects of the EBPCP during a specific time
period. Lastly, the impact feature of the Donabedian Framework includes how the
intervention will meet the “gold standard” for the proposed EBPCP (Fowler, 2012). For
our proposed EBPCP, the structural aspect of the Donabedian Framework was
selected. There are a number of rationale for selecting the structural aspect of the
Donabedian Framework: a) the structure for the proposed study will be in a moderately
sized Level-1 trauma center hospital in the Midwest, b) it employs several other
SEVERE TRAUMATIC BRAIN INJURY
23
healthcare providers such as: specialized areas of interventional radiology, neurology,
etc. and c) the clinical practice setting includes 23 private ICU rooms with appropriate
lighting equipped with the required resources.
The APN will monitor the implementation of the practice change by evaluating,
on a weekly basis, how many patients were admitted, how many received the external
method of cooling and how many maintained normothermia. The APN will monitor and
collect data including: ICP measurements, patient temperatures, GCS during the
hospital stay, GOS post discharge and compare results between the two interventions.
The individuals who are receiving external methods of cooling versus the individuals
who will be maintaining normothermia will have their ICP, temperatures, GCS, and GOS
compared at the end of the study. The intervention of external cooling will prove to be
succeeding or failing based upon the results between the two groups.
Budget
In order to examine the effectiveness of the clinical practice site’s current
protocol and to continue to explore other treatment protocols this moderately sized
Level-I trauma center will be required to employ an APN. The APN will require special
accommodations in order to conduct research and store data. A private office with a
door that locks near the ICU is important to maintain the integrity of the data collected.
In addition, the APN will require office furniture (desk, chair, locking file cabinet), a
computer (with Microsoft Word and Excel), and a printer. Basic office supplies (paper,
pens, and legal pads) will also be required.
In the State of Ohio, the average salary for an APN is $80,000 (Georgetown
University, 2012). The cost of hiring an APN to work a minimum of two days per week
SEVERE TRAUMATIC BRAIN INJURY
24
(104 days annually) dedicated to this EBPCP will be approximately $34,632. Initial
startup costs given that the APN is provided an empty office space would be
approximately $1,444 (desk, chair, file cabinet, computer, printer, basic office supplies)
(Staples, 2012). Additional basic office supply cost would be accumulated on an as
needed basis for replenishment of supplies. This would total approximately $200
annually. The grand total to the clinical practice site is $36,276 during the first year of
implementation (see Appendix E for Budget).
This moderately sized Level-1 trauma center will find that hiring an APN will
greatly enhance their capabilities of caring for patients with severe TBI. Not only will the
clinical practice site validate their current protocol in the management of severe TBI
based upon relevant data collection, they will also reap the benefits of an APN firmly
grounded in EBP. In addition to the proposed EBPCP, the APN’s role could be
expanded to explore better methods of cooling patients with severe TBI such as
intravascular cooling. Furthermore, the APN could explore advanced protocols related
to the care of all types of patients in the ICU and encourage them to explore practices
outside the current ICU protocols. Finally, the APN would be an excellent mentor to
encourage ICU RNs to get involved in current health policy at the local, state, and
national levels as well as promote professional advancement. With the rising incidence
and cost of TBI and its devastating impact upon patients, families, communities, and the
workplace, the cost of an APN is minimal. The shift toward a dedicated professional with
the responsibility of EBP research will only enhance the capabilities of the clinical
practice site, ultimately improving patient outcomes.
SEVERE TRAUMATIC BRAIN INJURY
25
Reference
Agency for Healthcare Research and Quality (2008). Nursing management of adults
with severe traumatic brain injury. Retrieved 8 April 2012, from
http://www.guideline.gov/content.aspx?id=13576&search=hypothermia+and+trau
matic+brain+injury
American Association of Neuroscience Nurses [AANN]. (2008). Nursing management of
adults with severe traumatic brain injury. (H. J. Thompson, Ed.) Glenview, IL.
Retrieved from www.AANN.org
Brain Injury Association of America (2011). Ohio TBI Prevalence Estimates. Retrieved 8
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CoCSN%20Areas+Demo%20graphic%20variabilities-diversity.pdf
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Wilde, E., Taylor, P., Harshman, K., Conley, A., Puccio, A., Levin, H., McCauley,
S., Bucholz, R., Smith, K., Schmidt, J., Scott, J., Yonas, H., & Okonkwo, D.
(2011). Very early hypothermia induction in patients with severe brain injury (the
National Acute Brain Injury Study: Hypothermia II): a randomised trial. Lancet
Neurology, 10(2), 131-139. doi:10.1016/S1474-4422(10)70312-4.
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therapeutic hypothermia after traumatic brain injury in adults: A systematic
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Melnyk, B., & Fineout-Overholt, E. (2011). Evidence-based practice in nursing &
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Williams: Wolters Kluwer Health.
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Peterson, K., Carson, S., & Carney, N. (2008). Hypothermia treatment for traumatic
brain injury: A systematic review and meta-analysis. Journal of Neurotrauma, 25,
62-71. doi: 10.1089/neu.2007.0424
Polit, R., & Beck, T. (2012). Resource manual for nursing research: Generating and
assessing evidence for nursing practice (9th ed.). Philadelphia, PA: Wolters
Kluwer Health and Lippincott Williams & Wilkins.
Puccio, A., Fisher, M., Jankowitz, B., Yonas, H., Darby, J., & Okonkwo, D. (2009).
Induced normothermia attenuates intracranial hypertension and reduces fever
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Saxena, M., Andrews, P., & Cheng, A. (2008). Modest cooling therapies (35oC to
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Sydenham, E., Roberts, I., & Alderson, P. (2009). Hypothermia for traumatic head
injury. The Cochrane Database of Systematic Reviews, 2009 (2), doi:
10.1002/14651858.CD001048.pub4.
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adults with severe traumatic brain injury. (H. J. Thompson, Ed.) Glenview, IL.
Retrieved from www.AANN.org
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Retrieved from http://www.healthypeople.gov/2020/default.aspx
SEVERE TRAUMATIC BRAIN INJURY
Zhao, Q.-J., Zhang, X.-G., & Wang, L.-X. (2011). Mild hypothermia therapy reduces
blood glucose and lactate and improves neurologic outcomes in patients with
severe traumatic brain injury. Journal of Critical Care, 26, 311-315.
doi:10.1016/j.jcrc.2010.08.014
28
Running head: SEVERE TRAUMATIC BRAIN INJURY
29
Appendix A – Synthesis of the Level of Evidence
Citation & study #
1.
Clifton, G., Valadka, A., Zygun,
D., Coffey, C., Drever, P.,
Fourwinds, S., Janis, L., Wilde,
E., Taylor, P., Harshman, K.,
Conley, A., Puccio, A., Levin, H.,
McCauley, S., Bucholz, R., Smith,
K., Schmidt, J., Scott, J., Yonas,
H., & Okonkwo, D. (2011). Very
early hypothermia induction in
patients with severe brain injury
(the National Acute Brain Injury
Study: Hypothermia II): a
randomized trial. Lancet
Neurology, 10(2), 131-139.
doi:10.1016/S14744422(10)70312-4
Design/metho
d
i.e., metaanalyses or
metasynthesis
from
Cochrane
database
RCT with
randomization
Sample/Setting
Major
variables
studied
97 (52
hypothermia & 45
normothermia
after
exclusion/inclusio
n criteria)
patients with nonpenetrating
severe brain
injury who were
16-45 years of
age and were not
responsive to
instructions upon
admission in 6
different sites
within USA and
Canada.
The
implementatio
n of either
hypothermia
(35°C & then
cooled to
33°C for 48 h
and then
gradually
rewarmed) or
the
implementatio
n of
normothermia
and its’ effects
on Glasgow
outcome
scale score at
6 months.
Measurement
or
instruments,
i.e.,
observation
or
psychometric
tools or
scales
The principal
outcome of
measurement
was the
Glasgow
outcome scale
score at 6
months. In
addition, the
Glasgow
outcome scale
was measured
at 3 months
and 6 months
after injury
and the
disability
rating scale
was measured
at 2 weeks, 4
weeks, 3
months, and 6
months after
injury. The
Glasgow
outcome scale
was adjusted
for age at
enrollment
and baseline
Glasgow
coma scale
score.
Data
analysis, i.e.,
Confidence
interval =
briefly
discuss
Researchers or
authors’
expected or
anticipated
outcomes
Findings or
results
Appraisal
Worth to
practice
Relative risk
is 1.08, 95%
CI 0.76–1.53;
p=0·67 for
patients with
poor
outcomes in
31 of 52
patients in the
hypothermia
group and 25
of 56 in the
normothermia
group
The initiation of
hypothermia will
reduce the
amount of
patients with
poor outcomes
at 6 months after
injury compared
to
normothermia.
Outcome was
poor for 31 of
52 patients
because of
severe
disability,
vegetative
state, or had
died in the
hypothermia
group (known
as poor
outcomes).
However,
outcome was
poor for 25 of
the 56 patients
in the
normothermia
group.
Strengths:
-Patients
were
randomized
-Investigators
who assessed
the outcome
measures
were blind to
treatment
distribution.
-Clear
description of
how and
length of time
of
hypothermia
-Clear
description of
time intervals
of Glasgow
Outcome
Scale
assessments
Relative risk
is 1.30, 95%
CI 0.58–2.52;
p=0.52) for
patients who
had died (12
patients in the
hypothermia
group died
compared
with eight in
the
normothermia
group).
12 patients in
the
hypothermia
group died
compared to 8
in the
normothermia
group.
*There was no
significant
difference in
outcome in
patients treated
with
hypothermia
compared to
those treated
Limitations:
-The size of
the trial
-The study
design was
designed to
evaluate the
complete
range of
patients with
severe brain
injuries rather
than
evaluation
SEVERE TRAUMATIC BRAIN INJURY
2.
Henderson, W. R., Dhingra, V. K.,
Chittock, D. R., Fenwick, J. C., &
Ronco, J. J. (2003). Hypothermia
in the management of traumatic
brain injury: A systematic review
and meta-analysis. Intensive
Care Medicine, 29(10), 16371644. doi:10.1007/s00134-0031848-2
Systematic
Review &
Meta-analysis
Patients
combined from
eight
randomized,
controlled trials to
produce a
population
of 748 severely
head-injured
patients.
Inclusion criteria:
Some studies
restricted the ICP
level, blunt
trauma and not
penetrating head
trauma.
Exclusion criteria:
in some studies,
prolonged
hypoxia or
hypotension or
multi-trauma. /
Executed at a
tertiary level
Canadian
teaching hospital.
30
The major
variables
studied
included:
1. studies that
examined at
least one
clinically
significant
outcome (i.e.
mortality
and/or
Glasgow
Outcome
Score);
2. incidence
of pneumonia
was included,
if recorded;
and
3.
hypothermia
in the
management
of traumatic
brain injury.
Data from the
studies were
abstracted by
WRH and
entered into
SPSS 11.0.
The two
principal
outcomes of
measurement
are mortality
and Glasgow
Outcome
Score (GOS)
at 6 months.
ICP values
were also
recorded.
Eight studies
provided data
on the
efficacy of
hypothermia
in the
management
of traumatic
brain injury.
The pooled
odds ratio of
morality in the
hypothermic
group is 0.81,
95% CI 0.591.13; p=0.22.
The odds
ratio of a poor
neurological
outcome
(GOS 1,2 or
3) is 0.75,
95% CI 0.56–
1.01; p=0.06.
The odds
ratio for
pneumonia in
the
normothermic
group is 0.42,
95% CI 0.25–
0.70;
p=0.001.
N/A
with
normothermia;
however,
patients in the
hypothermia
group had a
significant
number of
episodes of
increased ICP
in comparison
to those in the
normothermia
group.
The majority of
studies found
no significant
benefit with
between
patients who
maintained
normothermia
and who
received
hypothermia
treatments in
regards to
morality.
However, two
of the trials
illustrated a
significant
effect on
mortality, but
these two trials
had CI that
exceeded 1.
Four of the
eight studies
found a positive
effect of
hypothermia on
Glasgow
Outcome Score
outcomes.
However, for
two of these
studies the CI
exceeded 1.
patients with
hematomas
and/or diffuse
brain injury as
a separate
group.
Strengths:
-Randomized,
Controlled
Trials
Limitations:
- The design:
variation in
the enrolment
criteria,
the
management
of
hypothermia,
diagnosis
and reporting
of pneumonia
SEVERE TRAUMATIC BRAIN INJURY
3.
Sydenham, E., Roberts, I., &
Alderson, P. (2009). Hypothermia
for traumatic head injury. The
Cochrane Database of
Systematic Reviews, 2009 (2),
doi:
10.1002/14651858.CD001048.pu
b4
Cochrane
Review
23 trials with
1614 randomized
patients with any
closed traumatic
head injury
requiring
hospitalization.
Setting of sample
was not
addressed.
31
The major
variables
studied
included:
whether the
use of mild
hypothermia
reduced the
risk of death
(mortality),
vegetative
state, or
severely
disabled
(unfavorable
outcomes);
and if the risk
of pneumonia
is increased.
The following
data was
extracted from
each trial:
method of
masking
distribution of
patient
groups,
blinding of
outcome
assessment,
and number of
randomized
patients,
death or
severe
disability,
duration of
treatment,
duration of
follow up, loss
to follow up,
and number of
patients with
pneumonia
during the
treatment
period. The
data was
entered into
Review
Manager
(RevMan) by
ES; IR
checked for
accuracy.
There were a
number of
trials where it
was not
There were
fewer deaths
in patients
treated with
hypothermia
than in the
control group
(OR 0.85,
95% CI 0.68
to 1.06).
Patients
treated with
hypothermia
were less
likely to have
an
unfavorable
outcome than
those in the
control group
(OR 0.77,
95% CI 0.62
to 0.94).
N/A
Conclusions
regarding the
use of
hypothermia
are not strongly
supported by
the available
evidence.
There is no
evidence that
hypothermia is
beneficial in the
treatment of
head injury.
Hypothermia
may be
effective in
reducing the
possibility
death
and
unfavorable
outcomes for
traumatic head
injured patients,
but significant
benefit was
only found in
low quality
trials. The high
quality trials
found no
decrease in the
likelihood of
death with
hypothermia.
Strengths:
-Evaluated
1614
randomized
patients
Limitations:
-Majority of
the trials were
of low quality
-Low quality
trials may
overestimate
the
effectiveness
of
hypothermia
treatment.
SEVERE TRAUMATIC BRAIN INJURY
4.
American Association of
Neuroscience Nurses. (2008).
Nursing management of adults
with severe traumatic brain injury.
(H. J. Thompson, Ed.) Glenview,
IL. Retrieved from
www.AANN.org
Clinical
Practice
Guideline
This
recommendation
resulted from the
findings of a new
meta-analysis
of hypothermia
treatment for TBI
that
examined eight
trials (N = 781) of
comparable
groups.
32
The following
research
questions
were
addressed:
What nursing
interventions:
(a) maintain
or decrease,
(b) maintain
adequate
CPP or
increase, (c)
prevent DVT,
(d) promote
adequate
nutrition, (e)
prevent
hyperglycemi
a, prevent
seizures in
patients with
severe TBI
and What
monitoring
modalities can
successfully
guide nursing
interventions
in severe TBI.
possible to
determine the
method of
randomization
or masking
distribution of
patient groups
from the trial
report. These
trials were
excluded from
the review.
N/A
N/A
Purpose of the
CPG is to
provide
recommendation
s based on
current evidence
in the care of
adults with
severe TBI.
BTF (2008)
issued new
level 3
recommendatio
n for optimal
and cautious
use of induced
hypothermia in
adults. The
analysis
suggests that
hypothermia
maintained for
more than 48
hours reduces
mortality and
results
in favorable
neurological
outcomes when
they are
measured 1–2
years
postinjury. Of
interest was
the finding that
hypothermia
was of
significant
benefit only to
patients who
did not receive
barbiturates.
Induced
hypothermia is
associated with
complications.
Pneumonia
Strengths:
- CPG
reviewed
annually for
with targeted
review of
newly
published
literature.
- Cited 15
articles, BTF,
and
Cochraine
Library
review.
Limitations:
- Supports
induction of
hypothermia;
however
cautions ICU
nurse to be
aware of
potential
complications.
SEVERE TRAUMATIC BRAIN INJURY
5.
Saxena, M., Andrews, P., &
Cheng, A. (2008). Modest
Cooling Therapies (35oC to
37.5oC) for traumatic brain injury
(Review). Cochrane Database of
Systematic Reviews. doi:
10.1002/14651858.CD006811.pu
b2
Systematic
Review
There were 10
studies included
in the review. The
authors were
unable to find any
randomized,
placebocontrolled trials of
modest cooling
therapies after
TBI.
33
The major
variables
studied were:
1. Modest
cooling
therapies
reduce the
risk of a poor
outcome after
TBI (poor
outcome is
defined as the
composite
end-point of
death or
severe
disability).
2. Modest
cooling
therapies
increase the
risk of
intracranial
bleeding and
extracranial
For
dichotomous
outcomes:
results
expressed as
RR with 95%
CI. Data
pooled using
the randomeffects model
but the fixedmethod model
would also be
analyzed to
ensure
robustness of
the models
chosen and
susceptibility
to outliers.
For
continuous
scales of
measurement
to assess
Of the 10,
none were
found to meet
all the
inclusion
criteria. In
nine,
information
was provided
on physiologic
end-points
only, without
reference to
patient
outcomes. All
10 were
RCTs but only
4 were
placebocontrolled.
Three of the
four had
mixed
neurological
patient
The authors
sought to assess
the effects of
modest cooling
therapies
(defined as any
drug or physical
therapy aimed at
maintaining
body
temperature
between 35oC
and 37.5oC)
when applied to
patients in the
first week after
TBI.
rates as high as
40%–45% have
been reported
in hypothermia
trials;
a Cochrane
Library review
cited the odds
of patients
developing
pneumonia with
hypothermia
were nearly
double than the
odds for
normothermic
patients. The
2008
metaanalysis
warns the
increased risk
of pneumonia
may offset
the benefits of
hypothermia.
The authors
were unable to
find any
randomized,
placebocontrolled trials
of modest
cooling
therapies after
TBI. Therefore,
concluded that
there was no
evidence that
interventions
aimed at
reducing body
temperature
improved
patient
outcomes.
Strength:
Randomized,
placebocontrolled
trials or
controlled
clinical trials
would
represent the
best form of
evidence to
determine
whether a
particular
therapy
works,
because they
limit the error
that may be
introduced
into a study.
Limitation:
The inability
to find these
SEVERE TRAUMATIC BRAIN INJURY
6.
Zhao, Q.-J., Zhang, X.-G., &
Wang, L.-X. (2011). Mild
hypothermia therapy reduces
blood glucose and lactate and
improves neurologic outcomes in
patients with severe traumatic
brain injury. Journal of Critical
Care, 26, 311-315. doi:
10.1016/j.jcrc.2010.08.014
RCT with
randomization
The study was
conducted in
neurosurgical
units at
Liaocheng
People’s Hospital
in China between
Jan 2006 and
June 2009. Eight
one patients with
severe TBI were
selected that met
the following
criteria: (a) older
than 16 years, (b)
admission within
6 hours of
nonpenetrating
brain injury, (c) a
score on the
GCS between 3
and 8 after
resuscitation, (d)
no other chronic
34
bleeding.
3. Modest
cooling
therapies
increase the
risk of
pneumonia or
other serious
infections.
effectiveness
of treatment,
weighted
mean
difference, or
the
standardized
mean
difference.
Analysis of
heterogeneity
using a Chisquared test
on N-1
degrees of
freedom, with
an alpha of
0.05.
Main
variables: In
patients with
severe TBI.
Blood
glucose,
lactate,
hypothermia,
and
normothermia
.
Arterial blood
was used to
monitor the
level of
glucose and
lactate before
and after the
hypothermia
therapy. The
same blood
tests were
performed in
the
normothermia
group in the
same fashion.
GCS was
used to
assess
patient’s
condition
immediately
after
randomization
cohorts with
physiological
end-points as
the sole
outcome.
There was
one
randomized,
placebocontrolled
study that
included a
group of TBI
patients with
modest
temperature
intervention.
Follow up
contact with
the authors
was made
and the study
was excluded
because of
methodologic
al issues.
Blood glucose
of 10 mmol/L
or higher was
an
independent
predictor of
poor outcome
(GOS 2-3)
(adjusted RR,
5.7; 95% CI,
1.4-13.2; P >
.05).
Hypothermia
was an
independent
predictor for a
favorable
outcome
(GOS 4-5)
(RR, 4.9; 95%
CI, 1.0-15.6;
P < .05).
types of
studies
indicates that
there is no
satisfactory
evidence that
shows this
therapy is
safe and
effective.
Main objective of
this study was to
investigate the
association
between blood
glucose or
lactate and the
outcomes of
severe TBI, and
to evaluate the
effect mild
hypothermia
therapy on the
blood levels of
glucose and
lactate
No significant
difference in
the mean time
from injury to
randomization
in the 2 groups
(4.3 ± 0.9 vs.
4.5 ± 1.1 hours,
P > .05).
No significant
difference in
age, sex, prehospital
hypotension, or
hypoxemia (P >
.05). Baseline
GCS were
similar between
2 groups. More
patients in the
hypothermia
group required
mechanical
ventilation than
Strengths:
- Prospective
randomized
control trial.
- Clear
descriptions
of variables
and
measurement
outcomes.
- Included
clinical
outcomes 3
months post
injury.
- Well defined
treatment
protocols.
Limitations:
- Small
population (n
= 81), in
single medical
SEVERE TRAUMATIC BRAIN INJURY
illnesses before
the injury.
Patients were
randomly divided
in to
normothermia
group (n=41) and
hypothermia
group (n=40).
Patients with life
threatening
injuries to other
organs or systolic
BP <70mmHg
were excluded.
35
. GOS was
assessed 3
months after
the injury.
SPSS
software was
used for
statistical
analysis. Data
was presented
as means ±
SD. ANOVA
was used for
comparison of
means among
groups.
Categorical
data were
analyzed by
Fisher exact
test.
Correlations
were
calculated by
Spearman
rank
correlation
test.
Multivariate
associations
were analyzed
using Cox
proportional
hazards
model. The
associations
were
quantified with
RRs and 95%
CI. Two-tailed
P < .05 was
considered
statistically
significant.
in the
normothermia
(P > .05).
Hypothermia
was achieved
in 7.2 ± 2.9
hours after
injury &
maintained for
72.2 ± 2.1
hours (mean
body temp:
32.7oC ± 0.8oC.
No significant
difference in
baseline ICP (P
> .05). Mean
ICP in the
hypothermia
group was
lower than
normothermia
group 72 hrs
after treatment
(P < .01). Mean
glucose &
lactate levels
similar at
baseline, but
lower in
hypothermia
group after
treatment (P <
.05).
Three months
after treatment.
Patients in the
hypothermia
group had a
more favorable
recovery (GOS
4-5, 75% vs.
51.2%, P =
.038).
Percentage of
poor recovery
was
significantly
lower in the
hypothermia
center.
SEVERE TRAUMATIC BRAIN INJURY
7.
Peterson, K., Carson, S., &
Carney, N. (2008). Hypothermia
treatment for traumatic brain
injury: A systematic review and
meta-analysis. Journal of
Neurotrauma, 25, 62-71. doi:
10.1089/neu.2007.0424
Systematic
Review &
Meta-analysis
Although 13 trials
met eligibility
criteria, variations
in methodological
quality resulted in
analyses of 8
trials that
demonstrated the
lowest potential
for bias. A total
of 781 patients
were randomized
across trials
36
The major
variables:
Englishlanguage
publications of
RCTs that
compared the
benefit and
harms of
hypothermia
to standard
care upon
hospital
admission in
adults with
TBI. The
primary
effectiveness
outcome was
all-cause
mortality, the
secondary
outcome was
favorable
neurological
response
Outcome
measure for
primary
effectiveness
is mortality
(either alive or
not).
Favorable
neurological
response is
measured
using the
Glascow
Outcome
Scale at
various time
points
Pooled
relative risks
and
associated
95%
confidence
intervals were
calculated for
all variables
using
randomeffects
models.
Statistical
heterogeneity
was
calculated
using the chisquared test.
The pooled
study results
were unable
to produce a
statistically
significant
single effect
N/A
group (GOS 23, 25% vs.
48.8%, P =
.038).
Glucose was
inversely
correlated with
GOS scores in
both
hypothermia
and
normothermia
groups (r = 0.562, P > .01
vs. r = -0.677,
P < .01
respectively).
Lactate were
also inversely
related (r = 0.302, P < .05
vs. r = -0.366,
P < .05
respectively).
The best
available
limited
evidence
suggests that
hypothermic
therapy may
reduce the risk
of mortality and
improve
prospects for a
favorable
neurological
outcome in
certain
populations.
Ultimately, the
meta-analysis
didn’t resolve
existing
uncertainties
concerning
effectiveness of
hypothermia for
TBI, therefore
until more
Strength:
-evidence
derived from
RCTs
- A study
sensitivity
analysis
identified a
patient
population
where
hypothermia
treatment is
detrimental
(almost
threefold
increased risk
of pneumonia
associated
with
hypothermia
and
concomitant
barbiturate
use)
SEVERE TRAUMATIC BRAIN INJURY
37
measure for
either
outcome
when looking
at the whole
population.
However,
subgroup
analyses
confirmed
hypothermia
offered the
greatest
benefit to
decrease
mortality risk
when cooling
was
maintained for
more than 48
hours (RR
0.51, 95% CI
0.33, 0.79)
and when
barbiturate
medication
was not coadministered
with
hypothermia
therapy (RR
0.58, 95%, CI
0.40, 0.85).
Subgroup
analyses also
showed use
of
hypothermia
therapy
increased the
likelihood of a
favorable
neurological
outcome
when a)
hypothermia
was
maintained for
greater than
48 hours
evidence from
well conducted
trails becomes
available,
clinicians
should exercise
caution when
considering
hypothermia
therapy
Limitation:
-relatively
small number
of trials with
low potential
for bias
-inadequate
details
provided by
the trails
regarding
important
aspects of
trial design
and patient
characteristic
s
-inability to
assess the full
extent of
potential
harms due to
underreportin
g of adverse
event
outcomes
-outcome
measure of
neurological
response did
not take into
account more
specific
aspects of
recovery such
as return to
work, driving
and
independent
living
SEVERE TRAUMATIC BRAIN INJURY
8.
McIntyre, L., Ferfusson, D.,
Hebert, P., Moher, D. &
Hutchison, J. (2003). Prolonged
therapeutic hypothermia after
traumatic brain injury in adults: A
systematic review. Journal of the
American Medical Association
289(22), 2992-2999.
Systematic
Review
12 RCTs met
inclusion criteria.
There was a total
of 1069 patients:
543 in the
therapeutic
hypothermia
group and 526
patients in the
control
(normothermia)
group
38
All
randomized
controlled
trials of
therapeutic
hypothermia
for at least 24
hours vs
normothermia
in adults with
TBI
Primary
outcome
measure was
all cause
mortality at
the end of the
trial follow up
period. The
secondary
outcome
measure was
neurologic
outcome at
the end of the
trial follow-up
as measured
by Glasgow
Outcome
Scale
(RR1.91; 95%
CI 1.28, 2.85);
b) barbiturate
therapy was
not a
component of
ICP
management
(RR 1.79,
95% CI 1.27.
2.52); and c)
when trials
followed
patients for a
year or longer
after initial
injury (RR
1.72, 95%, CI
1.24, 2.38).
Data were
combined to
estimate the
pooled
relative risk
and 95%
confidence
intervals with
a randomeffects model.
Evidence of
publication
bias was
evaluated
with an
inverted
funnel plot,
presence of
statistical
heterogeneity
between
studies was
evaluated
using the
Cochran Q
test of
homogeneity
Pooled RR of
death
conferred a
protective
N/A
These study
results suggest
the greatest
clinical benefit
may be derived
when patients
are cooled to a
target temp of
32oC to 33oC,
with a
durationiof
greater than 48
hours, and
them rewarmed
within 24 hours
after
discontinuation
of hypothermia.
Although
therapeutic
hypothermia
may reduce the
risks of
mortality and
poor neurologic
outcome in
adults with TBI
in certain
situations, the
evidence is not
yet sufficient to
Strength:
-evidence
derived from
RCTs
Limitations:
-analysis
included a
small number
of high-quality
trials
-sources of
heterogeneity
(such as
intensity and
quality of care
delivered,
time from
injury to
initiation of
hypothermia,
cointervention
s for TBI
treatment and
adherence to
hypothermia
interventions
may have
affected
clinical
outcome
SEVERE TRAUMATIC BRAIN INJURY
9.
Puccio, A., Fisher, M., Jankowitz,
B., Yonas, H., Darby, J., &
Cohort study
A comparative
cohort study of
21 adult patients
39
Major
variables
studied:
Outcome
criteria were
all
effect of
therapeutic
hypothermia.
The greatest
reduction in
risk of death
occurred in
patients
cooled for
greater than
48 hours (RR
0.70, 95% CI
0.56, 0.87).
Pooled RR for
a poor
neurological
outcome
showed a
protective
effect of
hypothermia
in patients
with induced
moderate
hypothermia
(32oC to
33oC) and
rewarming
within 24
hours after
discontinuatio
n of
hypothermia
were
associated
with a
reduction in
the risk of a
poor
neurologic
outcome (RR
0.61; 95% CI,
0.45, 0.83)
and RR 0.79;
95% CI, 0.63,
0.98,
respectively)
The study
estimated the
percentage of
An induced
normothermia
protocol, utilizing
recommend
routine use of
therapeutic
hypothermia
assessments
Induced
hypothermia
(maintaining
Limitations:
-study only
measured the
SEVERE TRAUMATIC BRAIN INJURY
Okonkwo, D. (2009). Induced
normothermia attenuates
intracranial hypertension and
reduces fever burden after
traumatic brain injury.
Neurocritical Care 11, 82-87.
doi:10.1007/s12028-009-9213-0
with severe TBI
(GCS less than
8) treated with
induced
normothermia
using an
intravascular
cooling catheter
were matched by
age, gender and
severity of injury
to 21 historical
control severe
TBI patients
treated with
conventional
fever control
methods.
40
Comparison
of rectal core
temp and ICP
readings over
a three day
period
between
intervention
group
receiving
fever
prophylaxis
via
intravenous
cooling
catheter and
control group
that was
aggressively
managed with
conventional
fever
treatment
physiological
measures;
therefore,
assuming
proper
calibration and
maintenance
of the
equipment,
the outcome
criteria are
sourced by
objective
measurement
s. All the
physiological
data were
continuously
monitored and
downloaded
from the
bedside
monitor to a
patient data
server in
minute
increments.
Wilcoxon
signed rank
tests (nonparametric
rank tests)
were
performed for
each set of
parameters.
time within
the fever
range (rectal
temp greater
than 38oC
over the 72
hour
monitoring
period) for the
induced
normothermia
group verses
the control
group was
significantly
less (1.6%
versus 10.6%,
respectively).
Wilcox Signed
Rank test
resulted in a
significant
difference of
(p = 0.034)
between the
two groups.
The study
estimated the
average/mea
n ICP value
over the 72
hour
monitoring
period was
lower for the
induced
normothermia
group verses
the control
group (12.74
+ 4.0 and
16.37+ 6.9).
The Wilcox
Signed Rank
test resulted
in a significant
difference of
(p = 0.027)
between the
two groups
intravascular
cooling will be
more effective in
reducing fever
incidence and
intracranial
pressure
readings in
patients with
severe TBI
core body
temperature
between 36
and 36.5oC)
using an
intravascular
cooling catheter
(verses fever
reducing
protocols using
anit-pyretics
and cooling
blankets) is
effective in
reducing fever
burden and
reducing the
intracranial
pressure
readings.
Although core
body
temperatures in
the intervention
group never
reached
hypothermic
ranges, the
study validated
the efficacy of
intravascular
cooling over
conventional
cooling
techniques;
ultimately
endorsing the
use of an
intravascular
cooling catheter
as the best
method for
controlling core
body
temperature.
difference
between the
two group’s
intracranial
pressure
(ICP) and
temperature
readings for a
3 day period;
therefore long
term
outcomes
were not
detected
SEVERE TRAUMATIC BRAIN INJURY
41
The study
estimated the
percentage of
time the ICP
value was >
25mmHg for
the induced
normothermia
group verses
the control
group was
less (2.3 +
2.8% and 9.4
+ 11.4%,
respectively).
Wilcox Signed
Rank test
resulted in a
significant
difference of
(p = 0.03)
between the
two groups
SEVERE TRAUMATIC BRAIN INJURY
42
Appendix B – Levels and Types of Evidence Table
Levels and Types of Evidence
Level 1
Meta-analysis or meta-syntheses from Cochrane Review
Level 2
RCT with randomization
1
2
3
X
4
X
5
6
X
X
7
X
8
9
X
X
Level 3
RCT without randomization
Level 4
Case control or cohort study
X
Level 5
Systematic review of qualitative or descriptive study
Level 6
Single or individual qualitative or descriptive study Clinical
practice guidelines
X
Level 7
Expert opinion or state of the science report
1 = Clifton G, et al. (2011); 2 = Henderson WR, et al. (2003); 3 = Sydenham E, et al. (2009); 4 = AANN (2008); 5 =
Saxena M, et al. (2008); 6 = Zhao Q, et al. (2011); 7 = Peterson K, et al. (2008); 8 = McIntyre L, et al. (2003); 9 = Puccio
A, et al. (2009)
SEVERE TRAUMATIC BRAIN INJURY
43
APPENDIX C – Quality of Evidence
STUDY NUMBER
LEVEL OF EVIDENCE
QUALITY OF EVIDENCE
1 = Randomization
2 = Control of extraneous variables
3 = Credible instrumentation
SCORE
LxQ
DESIGN
3 = Poorly designed,
flawed
2 = Good design,
small sample or other
issues
1 = Great design,
large sample, no
major issues
1
2
3
6
2
2
1
N/A
N/A
N/A
3
1
N/A
N/A
N/A
4
6
N/A
N/A
N/A
5
1
N/A
N/A
N/A
6
2
3
6
2
7
1
N/A
N/A
N/A
8
1
N/A
N/A
N/A
9
4
2
8
2
1 = Clifton G, et al. (2011); 2 = Henderson WR, et al. (2003); 3 = Sydenham E, et al. (2009); 4 = AANN (2008); 5 =
Saxena M, et al. (2008); 6 = Zhao Q, et al. (2011); 7 = Peterson K, et al. (2008); 8 = McIntyre L, et al. (2003); 9 = Puccio
A, et al. (2009)
SEVERE TRAUMATIC BRAIN INJURY
44
Appendix D
SEVERE TRAUMATIC BRAIN INJURY
45
Appendix E