Randomized Evaluation of Operating Room Extubation After Cardiac Surgery
ConditionCardiac Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
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.
Eligibility criteria
Qualifiers
Adults (age 18+) scheduled for elective cardiac surgery requiring cardiopulmonary bypass
Low perioperative risk defined as STS Predicted Risk of Mortality (PROM) ≤ 3% based on the latest STS Adult Cardiac Surgery Database (ACSD) Risk Calculator
Deemed appropriate for OR extubation preoperatively by the attending cardiac surgeon
Able to provide informed consent
Disqualifiers
Underlying pulmonary disease requiring use of home supplemental oxygen
Pre-capillary pulmonary hypertension (mPAP ≥ 25 mmHg or PVR > 2 Wood units) on most recent right heart catheterization for any patient for which there is suspicion for pulmonary hypertension at the time of preoperative evaluation
Preoperative right ventricular dysfunction greater than mild on most recent echocardiogram
Obstructive sleep apnea with home CPAP or biPAP use or recommended use
Trial design
Treatments tested in this trial
- OR extubation
- ICU extubation
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
Massachusetts General Hospital
Lead sponsor
Brigham and Women's Hospital
Collaborator
Source ClinicalTrials.gov