NCT00729261

A Prospective Trial of Elective Extubation in Brain Injured Patients.

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Brain Injury

Interventions

Type	Name	Description
PROCEDURE	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.
PROCEDURE	continued intubation	patients remain intubated until their Glasgow coma scores improve to greater than 8.

Timeline

• Start date: 2004-08-01
• Primary completion: 2006-05-01
• Completion: 2006-05-01
• First posted: 2008-08-07
• Last updated: 2015-04-28

Locations

1 site across 1 country: United States