Guidelines for the Management of Severe TBI, 4th Edition
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LEVEL I
There was insufficient evidence to support a Level I recommendation for this topic.
LEVEL II A
Bifrontal DC is not recommended to improve outcomes as measured by the Glasgow Outcome Scale – Extended (GOS-E) score at 6 months post-injury in severe TBI patients with diffuse injury (without mass lesions), and with ICP elevation to values >20 mm Hg for more than 15 minutes within a 1-hour period that are refractory to first-tier therapies. However, this procedure has been demonstrated to reduce ICP and to minimize days in the intensive care unit (ICU).
A large frontotemporoparietal DC (not less than 12 x 15 cm or 15 cm diameter) is recommended over a small frontotemporoparietal DC for reduced mortality and improved neurologic outcomes in patients with severe TBI.
*The committee is aware that the results of the RESCUEicp trial may be released soon after the publication of these Guidelines. The results of this trial may affect these recommendations and may need to be considered by treating physicians and other users of these Guidelines. We intend to update these recommendations after the results are published if needed. Updates will be available here.
Changes from Prior Edition
DC is a new topic for the 4th Edition. DC had been included in the surgical guidelines.
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LEVEL I AND II A
There was insufficient evidence to support a Level I or II A recommendation for this topic.
LEVEL II B
Early (within 2.5 hours), short-term (48 hours post-injury) prophylactic hypothermia is not recommended to improve outcomes in patients with diffuse injury.
Changes from Prior Edition
In the 3rd Edition, the studies that compared hypothermia to normothermia were summarized in a meta-analysis. For this 4th Edition we re-examined the underlying assumptions of our prior work in light of the current standards for meta-analysis and decided not to repeat the meta-analysis because the hypothermia interventions in the higher-quality studies (Class 2 or better) differed across the studies in clinically important ways. More detail is provided in Appendix I.
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LEVEL I, II, AND III
Although hyperosmolar therapy may lower intracranial pressure, there was insufficient evidence about effects on clinical outcomes to support a specific recommendation, or to support use of any specific hyperosmolar agent, for patients with severe traumatic brain injury.
The Level II and III recommendations from the 3rd Edition of these guidelines are not supported by evidence meeting current standards because they were derived from studies that do not meet Class 3 criteria for this topic. While there is increasing use of hypertonic saline as an alternative hyperosmotic agent there is insufficient evidence available from comparative studies to support a formal recommendation. The Committee thus chose to re-state here the 3rd Edition recommendations. The rationale for doing so is to maintain sufficient recognition of the potential need for hyperosmolar therapy to reduce intracranial pressure, while acknowledging that more research is needed to inform more specific recommendations.
RECOMMENDATIONS FROM THE PRIOR (3RD) EDITION NOT SUPPORTED BY EVIDENCE MEETING CURRENT STANDARDS
Mannitol is effective for control of raised intracranial pressure (ICP) at doses of 0.25 g/kg to 1 g/kg body weight. Arterial hypotension (systolic blood pressure <90 mm Hg) should be avoided.
Restrict mannitol use prior to ICP monitoring to patients with signs of transtentorial herniation or progressive neurological deterioration not attributable to extracranial causes.
Changes from Prior Edition
The Committee is universal in its belief that hyperosmolar agents are useful in the care of patients with severe TBI. However, the literature does not currently support recommendations that meet the strict criteria for contemporary evidenced-based medicine approaches for guideline development.
The recommendations in the 3rd Edition of these guidelines about administration of hyperosmolar agents were based on one Class 2 study and nine Class 3 studies. The study included as Class 2 study was not a comparative study for this topic (it is a Class 2 trial about the use of barbiturates), and six of the studies that were rated as Class 3 studies were not comparative, and therefore did not meet current inclusion criteria.
In this 4th Edition we focused the search for new evidence explicitly on the comparative effectiveness of different hyperosmolar agents and means of administration.
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LEVEL I AND II
There was insufficient evidence to support a Level I or II recommendation for this topic.
LEVEL III
An EVD system zeroed at the midbrain with continuous drainage of CSF may be considered to lower ICP burden more effectively than intermittent use.
Use of CSF drainage to lower ICP in patients with an initial Glasgow Coma Scale (GCS) <6 during the first 12 hours after injury may be considered.
Changes from Prior Edition
This new topic, which was added to the 4th Edition as Cerebrospinal Fluid (CSF) drainage, is a potential treatment to lower intracranial pressure.
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LEVEL I AND II A
There was insufficient evidence to support a Level I or II A recommendation for this topic.
LEVEL II B
Prolonged prophylactic hyperventilation with partial pressure of carbon dioxide in arterial blood (PaCO2) of 25 mm Hg or less is not recommended.
As noted below, the Level III recommendations from the 3rd Edition of these guidelines were not carried forward because they were derived from case series studies. While no evidence is available from comparative studies to support a formal recommendation, the Committee chose to re-state here the 3rd Edition Level III recommendations. The rationale for doing so is to maintain sufficient recognition of the potential need for hyperventilation as a temporizing measure. (Refer to the 3rd Edition for summary of supporting studies.)
RECOMMENDATIONS FROM THE PRIOR (3RD) EDITION NOT SUPPORTED BY EVIDENCE MEETING CURRENT STANDARDS
Hyperventilation is recommended as a temporizing measure for the reduction of elevated intracranial pressure (ICP).
Hyperventilation should be avoided during the first 24 hours after injury when cerebral blood flow (CBF) is often critically reduced.
If hyperventilation is used, jugular venous oxygen saturation (SjO2) or brain tissue O2 partial pressure (BtpO2) measurements are recommended to monitor oxygen delivery.
Changes from Prior Edition
The title of this section was changed from Hyperventilation to Ventilation Therapies for the 4th Edition.
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LEVEL I AND II A
There was insufficient evidence to support a Level I or Level IIA recommendation for this topic.
LEVEL II B
Administration of barbiturates to induce burst suppression measured by EEG as prophylaxis against the development of intracranial hypertension is not recommended.
High-dose barbiturate administration is recommended to control elevated ICP refractory to maximum standard medical and surgical treatment. Hemodynamic stability is essential before and during barbiturate therapy.
Although propofol is recommended for the control of ICP, it is not recommended for improvement in mortality or 6-month outcomes. Caution is required as high-dose propofol can produce significant morbidity.
Changes from Prior Edition
There are no changes in content to the 3rd Edition recommendations (although revisions to wording have been made). Newly identified Class 3 studies have been added to the evidence but did not change the recommendations.
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LEVEL I
The use of steroids is not recommended for improving outcome or reducing ICP. In patients with severe TBI, high-dose methylprednisolone was associated with increased mortality and is contraindicated.
Changes from Prior Edition
The body of evidence was updated to include the 6-month outcomes of the CRASH trial. There were no changes to the recommendations for this topic.
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LEVEL I
There was insufficient evidence to support a Level I recommendation for this topic.
LEVEL II A
Feeding patients to attain basal caloric replacement at least by the 5th day and at most by the 7th day post-injury is recommended to decrease mortality.
LEVEL II B
Transgastric jejunal feeding is recommended to reduce the incidence of ventilator-associated pneumonia.
Changes from Prior Edition
Additional evidence was identified and incorporated into revised recommendations that emphasize early nutrition and address the method of feeding.
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LEVEL I
There was insufficient evidence to support a Level I recommendation for this topic.
LEVEL II A
Early tracheostomy is recommended to reduce mechanical ventilation days when the overall benefit is felt to outweigh the complications associated with such a procedure. However, there is no evidence that early tracheostomy reduces mortality or the rate of nosocomial pneumonia.
The use of povidone-iodine (PI) oral care is not recommended to reduce ventilator-associated pneumonia and may cause an increased risk of acute respiratory distress syndrome.
LEVEL III
Antimicrobial-impregnated catheters may be considered to prevent catheter-related infections during external ventricular drainage.
Changes from Prior Edition
The Level II recommendation from the 3rd Edition of these guidelines that stated “Periprocedural antibiotics for intubation should be administered to reduce the incidence of pneumonia” has not been carried forward. This was based one Class 2 study (still listed in the evidence table) that reported reductions in pneumonia but no improvement in mortality or function. The recommendation was not carried forward as the evidence of benefit is not strong and general critical care practice has established protocols to prevent VAP while infectious disease policies do not endorse this use of antibiotics.
Two questions are addressed in the 4th Edition of these guidelines for this topic. The question of prevention of VAP was maintained from the 3rd Edition because the rates of VAP are higher in TBI patients than non-TBI patients. Also, the question of prevention of infection associated with EVD was maintained. The recommendations from the 3rd Edition were revised due to new evidence.
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LEVEL I AND II
There was insufficient evidence to support a Level I or II recommendation for treatment of deep vein thrombosis (DVT) in severe TBI patients.
LEVEL III
Low molecular weight heparin (LMWH) or low-dose unfractioned heparin may be used in combination with mechanical prophylaxis. However, there is an increased risk for expansion of intracranial hemorrhage.
In addition to compression stockings, pharmacologic prophylaxis may be considered if the brain injury is stable and the benefit is considered to outweigh the risk of increased intracranial hemorrhage. There is insufficient evidence to support recommendations regarding the preferred agent, dose, or timing of pharmacologic prophylaxis for deep vein thrombosis.
Changes from Prior Edition
The Level 3 recommendation supporting use of compression stockings has been incorporated in the recommendation about pharmacologic prophylaxis, as mechanical treatments such as stockings are the general standard of care and there is not a body of evidence or issues that are TBI-specific. DVT pharmacologic prophylaxis is both a topic in general trauma and ICU care and a topic with issues specific to TBI, so the issues specific to TBI are the focus of the recommendations.
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LEVEL I
There was insufficient evidence to support a Level I recommendation for this topic.
LEVEL II A
Prophylactic use of phenytoin or valproate is not recommended for preventing late post traumatic seizures (PTS).
Phenytoin is recommended to decrease the incidence of early PTS (within 7 days of injury), when the overall benefit is felt to outweigh the complications associated with such treatment. However, early PTS have not been associated with worse outcomes.
At the present time there is insufficient evidence to recommend levetiracetam over phenytoin regarding efficacy in preventing early post-traumatic seizures and toxicity.
Changes from Prior Edition
The recommendations have not changed for this update from the 3rd Edition. Two new Class 2 studies and four new Class 3 studies were added as evidence, but these and the Class 3 studies included from the 3rd Edition did not provide sufficient evidence to inform new recommendations.
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LEVEL I AND II A
There was insufficient evidence to support a Level I or II A recommendation for this topic.
LEVEL II B
Management of severe TBI patients using information from ICP monitoring is recommended to reduce in-hospital and 2-week post-injury mortality.
The Level II and III recommendations from the 3rd Edition of these guidelines are not supported by evidence meeting current standards because they were derived from descriptive studies, or from studies that do not meet the current inclusion criteria for this topic. While no evidence is available from comparative studies to support a formal recommendation, the Committee chose to re-state here the 3rd Edition recommendations. The rationale for doing so is to maintain sufficient recognition of the patient characteristics associated with risk of increased intracranial pressure.
RECOMMENDATIONS FROM THE PRIOR (3RD) EDITION NOT SUPPORTED BY EVIDENCE MEETING CURRENT STANDARDS
Intracranial pressure (ICP) should be monitored in all salvageable patients with a severe traumatic brain injury (TBI) (GCS 3-8 after resuscitation) and an abnormal computed tomography (CT) scan. An abnormal CT scan of the head is one that reveals hematomas, contusions, swelling, herniation, or compressed basal cisterns.
ICP monitoring is indicated in patients with severe TBI with a normal CT scan if two or more of the following features are noted at admission: age over 40 years, unilateral or bilateral motor posturing, or systolic blood pressure (BP) <90 mm Hg.
Changes from Prior Edition
New Class 2 studies provide evidence for recommendations that replace those of the 3rd Edition of these guidelines.
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LEVEL I AND IIA
There was insufficient evidence to support a Level I and Level IIA recommendation for this topic.
LEVEL II B
Management of severe TBI patients using guidelines-based recommendations for CPP monitoring is recommended to decrease 2-week mortality.
Changes from Prior Edition
In the 3rd Edition of these guidelines, CPP monitoring and thresholds were combined into one section. In this edition they are reported separately with new evidence added. The recommendations from the 3rd Edition were about thresholds and are addressed in that topic in this 4th Edition.
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LEVEL I AND II
There was insufficient evidence to support a Level I or II recommendation for this topic.
(Although patients with desaturations identified with advanced cerebral monitoring have poorer outcomes, Level II evidence showed no improvement in outcomes for monitored patients.)
LEVEL III
Jugular bulb monitoring of arteriovenous oxygen content difference (AVDO2), as a source of information for management decisions, may be considered to reduce mortality and improve outcomes at 3 and 6 months post-injury.
Changes from Prior Edition
In the 3rd Edition of these guidelines, monitoring and thresholds were combined into one section. In this 4th Edition they are reported separately, and this topic has been renamed Advanced Cerebral Monitoring (ACM). The Level III recommendation about monitoring AVDO2 from the 3rd Edition was articulated as a statement, not a recommendation, and thus has been revised. The Level III recommendation about brain tissue oxygen monitoring has been removed because of higher-quality, contradictory evidence acquired since the 3rd Edition of these guidelines.
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LEVEL I AND II
There was insufficient evidence to support a Level I or II recommendation for this topic.
LEVEL III
Maintaining SBP at ≥100 mm Hg for patients 50 to 69 years old or at ≥110 mm Hg or above for patients 15 to 49 or over 70 years old may be considered to decrease mortality and improve outcomes.
Changes from Prior Edition
Recommendations from prior editions have been revised due to new evidence. The focus in this topic has been narrowed to concerns specific and different for TBI patients. Monitoring blood pressure and avoiding hypotension is considered general good trauma and ICU care and are not included. Brain tissue oxygenation is included in the Advanced Cerebral Monitoring section.
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LEVEL I AND II A
There was insufficient evidence to support a Level I or II A recommendation for this topic.
LEVEL II B
Treating ICP above 22 mm Hg is recommended because values above this level are associated with increased mortality.
LEVEL III
A combination of ICP values and clinical and brain CT findings may be used to make management decisions.
*The committee is aware that the results of the RESCUEicp trial may be released soon after the publication of these Guidelines. The results of this trial may affect these recommendations and may need to be considered by treating physicians and other users of these Guidelines. We intend to update these recommendations after the results are published if needed. Updates will be available here.
Changes from Prior Edition
A new Class 2 study provides evidence for the current recommendation which replaces the Level II recommendation in the 3rd Edition of these guidelines. The study that supported the 3rd Edition recommendation was found to be Class 3 in relation to the ICP Monitoring topic. (It remains Class 2 in relation to barbiturates. See Part II. Monitoring for details.)
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LEVEL I AND II A
There was insufficient evidence to support a Level I or II A recommendation for this topic.
LEVEL II B
The recommended target cerebral perfusion pressure (CPP) value for survival and favorable outcomes is between 60 and 70 mm Hg. Whether 60 or 70 mm Hg is the minimum optimal CPP threshold is unclear and may depend upon the patient’s autoregulatory status.
LEVEL III
Avoiding aggressive attempts to maintain CPP above 70 mm Hg with fluids and pressors may be considered because of the risk of adult respiratory failure.
Changes from Prior Edition
In the 3rd Edition of these guidelines, CPP monitoring and thresholds were combined into one section. In this edition they are reported separately with new evidence added.
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LEVEL I AND II
There was insufficient evidence to support Level I or II recommendation for this topic.
LEVEL III
Jugular venous saturation of <50% may be a threshold to avoid in order to reduce mortality and improve outcomes.
Changes from Prior Edition
In the 3rd Edition of these guidelines, monitoring and thresholds were combined into one section. In this 4th Edition they are reported separately, and this topic has been renamed Advanced Cerebral Monitoring (ACM) Thresholds. The Level III recommendation from the 3rd Edition about jugular venous saturation has been maintained. The Level III recommendation from the 3rd Edition about brain tissue oxygen monitoring has been revised based on reconsideration of the body of evidence.