We are studying whether waking patients up and removing the breathing tube (also known as "extubation") in the operating room after cardiac surgery improves postoperative recovery without causing harm.
This is a pragmatic, randomized controlled trial comparing OR extubation versus ICU extubation among adults undergoing elective cardiac surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
Immediate extubation in the operating room (OR) at the conclusion of cardiac surgery
Extubation in the intensive care unit (ICU) within 6 hours of leaving the operating room after cardiac surgery
Brigham and Women's Hospital
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Hierarchical composite endpoint, ordered by clinical priority
1. Death by postoperative day 15; 2. Unplanned reintubation or cumulative mechanical ventilation \> 12 hours from OR exit, assessed through 48 hours postoperatively; 3. Days at home through postoperative day 15 (DAH-15). DAH-15 will be measured from the time of post-operative ICU admission and will subtract any time spent in a hospital (index hospitalization or readmission), rehabilitation center, or nursing facility.
Time frame: 15 days postoperatively
Postoperative ICU length of stay
Cumulative length of stay (hours) in an intensive care unit (ICU) following cardiac surgery
Time frame: 30 days
Postoperative hospital length of stay
Length of index hospitalization (hours) following cardiac surgery
Time frame: 30 days
Use of non-invasive respiratory support
Use of non-invasive respiratory support such as biPAP, CPAP, or high flow oxygen after OR exit
Time frame: 48 hours
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