An interventional study of OR extubation and ICU extubation in Cardiac Surgery, sponsored by Massachusetts General Hospital. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment
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.
Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.
Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Sep 28, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
We will also exclude patients undergoing the following procedures:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Extubation in the operating room (OR) at the conclusion of cardiac surgery
Procedure: OR extubation
Extubation in the intensive care unit (ICU) within 6 hours of leaving the OR
Procedure: ICU extubation
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
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
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for May 2027, 6 months later.
Start moved twice since we started tracking on Sep 25, 2026: Aug 2026 → Nov 2026, last on Nov 10, 2026.
Primary completion moved twice since we started tracking on Sep 25, 2026: Feb 2027 → May 2027, last on Nov 10, 2026.
Completion moved once since we started tracking on Sep 25, 2026: Mar 2027 → Jun 2027, on Sep 28, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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