A Prospective Trial of Elective Extubation in Brain Injured Patients.

Study Overview
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Brief Summary
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Identifying the optimal time of extubation in a brain injured population should improve patient outcome. Brain injured patients usually remain intubated due to concerns of airway maintenance. Current practice argues that unconscious patients need to remain intubated to protect their airways. More recent data however suggests that delaying extubation in this population increases pneumonias and worsens patient outcomes. We designed a safety and feasibility study of randomizing brain injured patients into early or delayed extubation. The purpose was to gain insight into patient safety concerns and to obtain estimates of sample size needed for a larger study.

Official Title
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A Prospective Trial of Elective Extubation in Brain Injured Patients Meeting Extubation Criteria for Ventilatory Support.

Conditions
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Brain Injury

Intervention / Treatment
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* Procedure: extubation
* Procedure: continued intubation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Resolution or improvement of any pulmonary process requiring mechanical ventilation. Adequate gas exchange. Adequate ventilation. Respiratory rate to tidal volume ratio <105. Core body temperature < 38 degrees celsius. Hemoglobin > 8 grams per deciliter. No sedative medications for 2 hours. Neurological requirements included: GCS ≤ 8. Intracranial pressure (ICP) < 15 cm of water and a cerebral perfusion pressure (CPP) > 60 mm Hg for patients with intracranial pressure monitors. Exclusion Criteria: Age < 18 years. Lack of informed consent by the patients' surrogate. Dependence on mechanical ventilation for at least two weeks prior to enrollment. Patients with tracheostomies. Intubation instituted for therapeutic hyperventilation. Planned surgical or radiological intervention within the next 72 hours. Anticipated neurological or medically worsening conditions (i.e develop cerebral edema or vasospasm). Patients intubated for airway preservation due to airway edema (cervical neck injuries or surgery) as opposed to airway protection.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: armA I<br>Patients remain intubated until the patients Glasgow coma score improves to greater than 8. | Procedure: continued intubation<br>* patients remain intubated until their Glasgow coma scores improve to greater than 8.<br>|
| Experimental: arm 2<br>Patients that meet standard airway and ventilatory criteria for extubation but have a Glasgow coma score of less than or equal to 8 are immediately extubated. | Procedure: extubation<br>* Brian injured patients that remained intubation solely because of a depressed level of consciousness were randomized into immediate extubation or delayed extubation until their level of consciousness improved.All patients met standard ventilatory, and airway criteria for extubation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Rankin Score |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nosocomial pneumonias |  | hospital discharge | 
| reintubations |  | hospital discharge | 
| ICU length of stay |  | hospital discharge | 
| hospital length of stay |  | hospital discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mechanical ventilation, extubation, outcomes, brain injury