Could waking up in the operating room speed heart surgery recovery?

NCT ID NCT07757880

Disease control Sponsor: Massachusetts General Hospital Source: ClinicalTrials.gov ↗

First seen Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time

Summary

This trial is testing whether removing the breathing tube in the operating room right after cardiac surgery, instead of waiting until the patient is in the intensive care unit, can improve recovery. The study will include 120 adults at low risk undergoing elective heart surgery with a heart-lung machine. Participants will be randomly assigned to have their breathing tube removed either in the operating room or in the ICU within six hours, and researchers will compare outcomes like complications, time on a ventilator, and days spent at home after surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: A procedure comparing immediate breathing-tube removal in the operating room versus removal in the intensive care unit within 6 hours after cardiac surgery.
What this could lead to: If removing the breathing tube in the operating room proves safer and speeds recovery, it could become a standard practice for low-risk cardiac surgery patients, leading to shorter hospital stays and fewer complications.
What could go wrong: This is a relatively small, early-stage trial, and the results may not apply to all cardiac surgery patients. There is a risk that immediate extubation in the operating room could lead to breathing difficulties or other complications in some individuals.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 * 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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiac surgery

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

2 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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Could waking up in the operating room speed heart surgery recovery?

What the study statuses mean