2. Introduction
4th Edition of the BTF guidelines-
Living Guidelines model
Transitional
Not intend to produce a 5th Edition
A model of continuous monitoring of the literature, rapid updates to
the evidence review
Revisions to the recommendations as the evidence warrants
3. The Role of the BTF GUIDELINES
• A service organization dedicated to improving outcomes from TBI
• A evidence based guideline
The Scope of the Guidelines
• Address treatment interventions
• Monitoring
• Treatment thresholds that are particular to TBI or
• That address a risk that is higher in TBI patients
4. Methods
The development of guidelines encompasses two major activities:
• A systematic review and synthesis of evidence
• The derivation of recommendations
189 publications used for evidence-
5 Class 1,
46 Class 2,
136 Class 3 studies, and
2 meta-analyses
5. • Class 1:
Highest class and is limited to good-quality RCTs
• Class 2:
Moderate-quality RCTs and good-quality cohort or case-control
studies
• Class 3:
Lowest class and is given to low-quality RCTs
Moderate- to low-quality cohort or case control studies
Case series and other non-comparative designs
6. Level of Recommendation
• Determined by the assessment of the quality of the body of evidence,
rather than the class of the included studies
• Primarily based on the quality of the body of evidence
• Level I ( STANDARD) : high-quality - prospective RCTs
• Level II A ( GUIDELINE) : moderate-quality – well designed controlled
trials without randomization
• Level II B (GUIDELINE): low-quality- well designed cohort or case
controlled study
• Level III( OPTIONAL) : low-quality- case series, case reports, expert
opinion
7. Topics Included in This Edition
• The topics are organized in three categories that are specific to severe
TBI in adults:
1. Treatments
2. Monitoring
3. Thresholds
9. Major Changes for This Edition
SUMMARY:
• Cerebral Fluid Drainage (New topic)
• Decompressive Craniectomy (New topic)
• Deep Vein Thrombosis-
For risks that are TBI-specific
Direct evidence was not identified
Indirect evidence was identified and included
• Intracranial Pressure Technology- assessment is outside the scope of
management guidelines and no longer included
• Hyperventiliation-renamed “Ventilation Therapies”
10. Continu….
• Brain Oxygen Monitoring- renamed “Advanced Cerebral Monitoring”
• Infection Prophylaxis
Focus on Ventilator Associated Pneumonia (VAP)
External Ventricular Drain infections
Indirect evidence was identified and used
• Intracranial Pressure Monitoring, Cerebral Perfusion Pressure
Monitoring, Advanced Cerebral Monitoring
Divided into
(a) Benefits and risks of monitoring (Monitoring)
(b) Values to be targeted or avoided (Thresholds)
11. 1. Decompressive Craniectomy
INTRODUCTION:
• Cerebral edema can result from a combination of several pathological
mechanisms a/w primary and secondary injury patterns in TBI
• As pressure within the skull increases, brain tissue displacement can
lead to cerebral herniation, resulting in disability or death
• Surgical removal of a “portion of the skull” k/a decompressive
craniectomy (DC)
• Performed for the purpose of relieving elevated ICP with outcome
improvement in specific TBI patients
12. RECOMMENDATIONS
• Level I
• 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)
13. Changes from Prior Edition
• DC is a new topic for this 4th Edition
• DC had been included in the surgical guidelines
14. 2. Prophylactic Hypothermia
INTRODUCTION:
• Hypothermia is well recognized to preserve cells and tissue in the face
of metabolic challenge
• Evidence supports the administration of hypothermia as standard of
care for neuroprotection after cardiac arrest from acute coronary
syndromes
• In addition to suggested neuroprotective effects, hypothermia is well
known for its ability to reduce ICP
• Hypothermia bears risks, including coagulopathy and
immunosuppression
• Profound hypothermia bears the additional risk of cardiac dysrhythmia
and death
15. RECOMMENDATIONS
Level I and II A
Insufficient evidence to support a Level I or II A recommendation
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
16. Changes from Prior Edition In the 3rd Edition
• The studies that compared hypothermia to normothermia were
summarized in a meta-analysis
• For 4th Edition- 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
17. 3. Hyperosmolar Therapy
INTRODUCTION
• Mannitol was previously thought to reduce ICP through simple brain
dehydration
• Both mannitol and hypertonic saline work to reduce ICP
Reducing blood viscosity
Improved microcirculatory flow of blood constituents and
Consequent constriction of the pial arterioles
18. RECOMMENDATIONS
• Level I, II, and III
• 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 TBI
19. 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
20. 4. Cerebrospinal Fluid Drainage
INTRODUCTION:
• Management of external ventricular drainage (EVD) systems in
patients with TBI remains a controversial topic
• EVD in a closed position allows for monitoring of ICP
• EVD in open position allows drainage of CSF can occur
• EVD should be maintained in a closed or open position vary widely
based on a number of variables, including patient’s age, institutional
resources, and physician preferences
21. • A key variable in EVD management appears to be related to patient
age. In the pediatric population continuous CSF drainage is a relatively
common practice with evidence to support improvements in both ICP
management and injury biomarkers.
22. RECOMMENDATIONS
• 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 GCS<6 6
during the first 12 hours after injury may be considered
23. Changes from Prior Edition
• New topic, added to the 4th Edition as CSF drainage
• Potential treatment to lower ICP
24. 5. Ventilation Therapies
INTRODUCTION
• Patients with severe TBI require definitive airway protection
• They are at risk of pulmonary aspiration or compromised respiratory
drive and function
• May also require transient hyperventilation to treat cerebral
herniation
• Normal ventilation is currently the goal for severe TBI patients in the
absence of cerebral herniation and normal PaCO2 ranges(35-45 mm
Hg)
25. • CBF is linearly responsive to PaCO2
• Low PaCO2- results in low CBF and may result in cerebral ischemia
• High PaCO2- result in cerebral hyperemia and ICP
• Severe TBI patients receive mechanical ventilation, which can tightly
regulate PaCO2 levels through rate and tidal volume adjustments
26. Older studies suggested-
Cerebral hyperemia was more common than cerebral ischemia
Hyperventilation was recommended in the care of patients with TBI
More recent studies- after severe TBI, cerebral metabolic rate is not
always low and can be variable
In fact, cerebral ischemia has been documented in a number of studies
after severe TBI
Therefore, the high prevalence of cerebral ischemia in these patients
suggests safety in providing normoventilation so as to prevent further
cerebral ischemia and infarction
27. • Level I and II A
• Isufficient evidence to support a Level I or II A recommendation f
• Level II B
• Prolonged prophylactic hyperventilation with PaCO2 of 25 mm Hg or
less is not recommended
28. 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 ICP
• Hyperventilation should be avoided during the first 24 hours after injury
when 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
29. Changes from Prior Edition
• The title was changed from Hyperventilation to Ventilation Therapies.
30. 6. Anesthetics, Analgesics, and Sedatives
INTRODUCTION
• Anesthetics, analgesics, and sedatives are important and commonly-
used therapies in acute TBI for a variety of reasons
• Prophylaxis or control of IH and seizures
• To control ICP by preventing unnecessary movement, coughing, and
straining against tubes
• Barbiturates, may also improve coupling of regional blood flow to
metabolic demands resulting in higher brain oxygenation with lower
CBF, and decreased ICP from decreased CBV
• Other brain protective mechanisms- inhibition of oxygen radical
mediated lipid peroxidation
31. • Side effects-
Hypotension and decreased cardiac output, as well as increased
intrapulmonary shunting, which may lead to hypoxia
These may give rise to a paradoxical decrease in CPP which may negate
the benefits of decreased ICP
32. RECOMMENDATIONS
• Level I and II A
• There was insufficient evidence to support a Level I or Level IIA
recommendation
• Level II B
• Administration of barbiturates to induce burst suppression measured by
EEG as prophylaxis against the development of IH 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
• Propofol is recommended for the control of ICP and not recommended for
improvement in mortality or 6-month outcomes
• Caution is required as high-dose propofol can produce significant morbidity
33. Changes from Prior Edition
• No content changes from the 3rd Edition to the recommendations
34. 7. Steroids
INTRODUCTION
• Steroids were introduced in the early 1960s as a treatment for brain edema
• Experimental evidence accumulated that steroids were useful in the
restoration of altered vascular permeability in brain edema-
Reduction of CSF production
Attenuation of free radical production
• Glucocorticoids were found to be beneficial to patients with brain tumors
when administered in the perioperative period
• Based on this experience glucocorticoids became commonly administered
to patients undergoing a variety of neurosurgical procedures and became
commonplace in the treatment of severe TBI
• However, studies of severe TBI patients failed to find a benefit
(CRASH trial)
35. RECOMMENDATIONS
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.14 There were no
changes to the recommendations
36. Changes from Prior Edition
• The body of evidence was updated to include the 6-month outcomes
of the CRASH trial
• No changes to the recommendations
37. 8. Nutrition
INTRODUCTION
• Seminal work from the 1980s demonstrated that severe TBI was
associated with increased energy expenditure early after injury
• TBI itself causes an intrinsic increase in metabolism and requirement
for caloric support
38. RECOMMENDATIONS
• Level I
• There was insufficient evidence to support a Level I recommendation
• Level II A
• Feeding patients to attain basal caloric replacement at least by the
fifth day and, at most, by the seventh day post-injury is
recommended to decrease mortality
• Level II B
• Transgastric jejunal feeding is recommended to reduce the incidence
of ventilator associated pneumonia
39. Changes from Prior Edition
Additional evidence was identified and incorporated into revised
recommendations that emphasize
Early nutrition and
Address the method of feeding
40. 9. Infection Prophylaxis
INTRODUCTION
• Severe TBI can increase a patient’s susceptibility to infection-
• Necessary mechanical ventilation to prevent airway obstruction,
aspiration
• Infection risks –VAP and central line-associated bacteremias are
increased in all critically ill patients
• Patients undergoing ICP monitoring are reported to have related
infection rates as high as 27%
41. RECOMMENDATIONS
Level I
• There was insufficient evidence to support a Level I recommendation
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 VAP 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 EVD
42. 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
43. 10. Deep Vein Thrombosis Prophylaxis
INTRODUCTION
• Patients with TBI are at significant risk for developing venous
thromboembolism (VTE)
• TBI has been a/w up to 54% incidence of deep venous thrombosis
without prophylactic treatment
• 25% incidence in patients with isolated TBI treated with sequential
compression devices
• Reiff et al. demonstrated a three-to-four-fold increase in the DVT risk
in TBI despite use of mechanical and chemoprophylaxis
44. • Severe TBI patients can be at significant risk for VTE due to
hypercoagulability resulting from the primary brain injury, prolonged
periods of immobilization, and focal motor deficits
• If untreated, DVT can result in potentially debilitating or fatal
pulmonary embolism
45. RECOMMENDATIONS
• Level I and II
• There was insufficient evidence to support a Level I or II
recommendation
• 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
46. 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
47. 11. Seizure Prophylaxis
INTRODUCTION
• Acute symptomatic seizures may occur as a result of severe TBI
• Such post-traumatic seizures (PTS) are classified-
• Early within 7 days of injury
• Late after 7 days following injury
• Post-traumatic epilepsy (PTE) is defined as recurrent seizures more than 7
days following injury
• In patients with severe TBI, the rate of clinical PTS may be as high as 12%,
• while that of subclinical seizures detected on electroencephalography may
be as high as 20% to 25%
48. The risk factors for early PTS include
• GCS score of ≤10
• Immediate seizures
• Post-traumatic amnesia lasting longer than 30 minutes
• Linear or depressed skull fracture
• Penetrating head injury
• Subdural, epidural, or intracerebral hematoma
• Cortical contusion
• Age ≤65 years
• Chronic alcoholism
49. RECOMMENDATIONS
• 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 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
50. Changes from Prior Edition
• The recommendations have not changed for this update from the 3rd
Edition
51. 12. Intracranial Pressure Monitoring
INTRODUCTION
• A mainstay of the care of the patients with the most severe brain
injuries has been the monitoring treatment of ICP
• Because of its fundamental place in the care of patients with severe
TBI and its relationship to overall outcomes, ICP monitoring has been
included in every guideline for severe TBI published by the BTF
52. RECOMMENDATIONS
• Level I and II A
• There was insufficient evidence to support a Level I or II A
recommendation for ICP monitoring
• 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
53. Recommendations from the Prior (3rd) Edition Not
Supported by Evidence Meeting Current Standards
• Recommendations from the Prior (3rd) Edition Not Supported by Evidence
Meeting Current Standards
• ICP should be monitored in all salvageable patients with a severe TBI (GCS
3-8 after resuscitation) and an abnormal 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
SBP< 90 mm Hg
54. Changes from Prior Edition
• New Class 2 studies provide evidence for recommendations that
replace those of the 3rd Edition of these guidelines