A Prospective Trial of Elective Extubation in Brain Injured Patients.
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.
|Brain Injury||Procedure: extubation Procedure: continued intubation||Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Prospective Trial of Elective Extubation in Brain Injured Patients Meeting Extubation Criteria for Ventilatory Support.|
- 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 ]
|Study Start Date:||August 2004|
|Study Completion Date:||May 2006|
|Primary Completion Date:||May 2006 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00729261
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Study Director:||Edward M. Manno, M.D.||Mayo Clinic|