A Prospective Trial of Elective Extubation in Brain Injured Patients.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2006-05-31

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.

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Detailed Description

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Conditions

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Brain Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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armA I

Patients remain intubated until the patients Glasgow coma score improves to greater than 8.

Group Type EXPERIMENTAL

continued intubation

Intervention Type PROCEDURE

patients remain intubated until their Glasgow coma scores improve to greater than 8.

arm 2

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.

Group Type EXPERIMENTAL

extubation

Intervention Type PROCEDURE

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.

Interventions

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extubation

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.

Intervention Type PROCEDURE

continued intubation

patients remain intubated until their Glasgow coma scores improve to greater than 8.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Resolution or improvement of any pulmonary process requiring mechanical ventilation.
2. Adequate gas exchange.
3. Adequate ventilation.
4. Respiratory rate to tidal volume ratio \<105.
5. Core body temperature \< 38 degrees celsius.
6. Hemoglobin \> 8 grams per deciliter.
7. No sedative medications for 2 hours.

Neurological requirements included:

1. GCS ≤ 8.
2. Intracranial pressure (ICP) \< 15 cm of water and a cerebral perfusion pressure (CPP) \> 60 mm Hg for patients with intracranial pressure monitors.

Exclusion Criteria

1. Age \< 18 years.
2. Lack of informed consent by the patients' surrogate.
3. Dependence on mechanical ventilation for at least two weeks prior to enrollment.
4. Patients with tracheostomies.
5. Intubation instituted for therapeutic hyperventilation.
6. Planned surgical or radiological intervention within the next 72 hours.
7. Anticipated neurological or medically worsening conditions (i.e develop cerebral edema or vasospasm).
8. Patients intubated for airway preservation due to airway edema (cervical neck injuries or surgery) as opposed to airway protection.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No