Randomized Evaluation of Operating Room Extubation After Cardiac Surgery

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type

Interventional

Phase

Not applicable

Age range

18 years - Not specified

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

120 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Random assignment

Masking

Double masked

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (2)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

2 locations

Study team and timeline

Lead sponsor

Massachusetts General Hospital

Study start

Nov 9, 2026 Estimated

Primary completion

2027-05 Estimated

Study completion

2027-06 Estimated

First posted

Aug 11, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts