A Prospective Trial of Elective Extubation in Brain Injured Patients.

Phase 1

Completed

• Conditions: Brain Injury
• Interventions: Procedure: continued intubation; Procedure: extubation

• Registration Number: NCT00729261
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2004-08
• Primary Completion: 2006-05
• Study Completion: 2006-05
• Status Verified: 2008-08
• Study First Submitted: 2008-08-01
• Study First Submitted QC: 2008-08-01
• Study First Posted: 2008-08-07
• Last Update Submitted: 2015-04-27
• Last Update Posted: 2015-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
armA I	continued intubation	Patients remain intubated until the patients Glasgow coma score improves to greater than 8.
arm 2	extubation	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.

Primary Outcome Measures

Name	Time	Method
Modified Rankin Score	6 months

Secondary Outcome Measures

Name	Time	Method
reintubations	hospital discharge
ICU length of stay	hospital discharge
nosocomial pneumonias	hospital discharge
hospital length of stay	hospital discharge

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States