A Prospective Trial of Elective Extubation in Brain Injured Patients.
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|ClinicalTrials.gov Identifier: NCT00729261|
Recruitment Status : Completed
First Posted : August 7, 2008
Last Update Posted : April 28, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain Injury||Procedure: extubation Procedure: continued intubation||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Prospective Trial of Elective Extubation in Brain Injured Patients Meeting Extubation Criteria for Ventilatory Support.|
|Study Start Date :||August 2004|
|Actual Primary Completion Date :||May 2006|
|Actual Study Completion Date :||May 2006|
Experimental: armA I
Patients remain intubated until the patients Glasgow coma score improves to greater than 8.
Procedure: continued intubation
patients remain intubated until their Glasgow coma scores improve to greater than 8.
Experimental: 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.
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.
- Modified Rankin Score [ Time Frame: 6 months ]
- nosocomial pneumonias [ Time Frame: hospital discharge ]
- reintubations [ Time Frame: hospital discharge ]
- ICU length of stay [ Time Frame: hospital discharge ]
- hospital length of stay [ Time Frame: hospital discharge ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00729261
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Study Director:||Edward M. Manno, M.D.||Mayo Clinic|