Oral Extubation Right After Cardiac Surgery
Official title: Randomized Evaluation of Operating Room Extubation Versus Intensive Care Unit Extubation After Cardiac Surgery
Run by Massachusetts General Hospital · NCT07757880 · Data updated 2026-11-12
This trial tests whether waking patients and removing the breathing tube in the operating room after elective cardiac surgery helps recovery more quickly without added risk.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Status | Recruiting |
| Started | November 9, 2026 |
| Main results expected | May 2027 |
| Study ends | June 2027 |
| Registry record updated | November 10, 2026 |
| Trial ID | NCT07757880 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18+ undergoing elective cardiac surgery requiring cardiopulmonary bypass, with STS PROM ≤ 3%, and deemed suitable for OR extubation by their surgeon.
✕Probably not a fit
Patients with certain respiratory, pulmonary, or BMI factors, or those not eligible for OR extubation, may not benefit and could be excluded from the advantage of earlier extubation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pragmatic, randomized study compares extubation in the operating room to extubation in the ICU for adults undergoing elective cardiac surgery with bypass. Participants are adults 18 and older at low to moderate risk who are deemed suitable for OR extubation by their surgeon. The study aims to determine if OR extubation can improve recovery while keeping safety at the forefront. It is conducted at Massachusetts General Hospital and Brigham and Women’s Hospital.
Why it matters
Potential benefit: If successful, OR extubation could shorten recovery times and reduce ICU resources after cardiac surgery.
How similar studies have gone: Prior studies in similar settings have explored OR extubation messaging, with some showing potential benefits but mixed safety data in broader populations.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * BMI ≥ 35 * Obstructive sleep apnea with home CPAP or biPAP use or recommended use * Neuromuscular disease associated with respiratory muscle weakness including myasthenia gravis, Lambert-Eaton myasthenic syndrome, or muscular dystrophy * Airway abnormalities including tracheostomy, history of difficult mask ventilation, history of difficult intubation requiring fiberoptic rescue or multiple (\>2) attempts, known anatomic abnormalities including limited mouth opening (\< 3cm), severe micrognathia, tracheal stenosis, or tracheal compression due to mass or goiter We will also exclude patients undergoing the following procedures: * Transplant surgery * Pulmonary thromboendarterectomy * Implantation of mechanical circulatory support including LVAD, Impella, intra-aortic balloon pump, RVAD, or ECMO
Where it's running
-
Massachusetts General Hospital
Boston, Massachusetts, United States Recruiting -
Brigham and Women's Hospital
Boston, Massachusetts, United States Not yet recruiting
Study contacts
- Study coordinator: Lauren Gibson, MD
- Email: legibson@mgh.harvard.edu
- Phone: 617-726-3030
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.