Recruiting

Observational Study

Sponsor:

Massachusetts General Hospital

Code:

NCT07757880

Conditions

Cardiac Surgery

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

OR extubation

ICU extubation

Study Details

Brief summary:

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.

Conditions

Cardiac Surgery

Study ID

NCT07757880

Start date

Nov 9, 2026

Status verified date

Oct, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: OR extubation

Extubation in the operating room (OR) at the conclusion of cardiac surgery

placebo comparator: ICU extubation

Extubation in the intensive care unit (ICU) within 6 hours of leaving the OR

Interventions

OR extubation

Immediate extubation in the operating room (OR) at the conclusion of cardiac surgery

ICU extubation

Extubation in the intensive care unit (ICU) within 6 hours of leaving the operating room after cardiac surgery

Primary outcome measure

  • Hierarchical composite endpoint, ordered by clinical priority [ Time Frame: 15 days postoperatively ]

Central Contacts and Locations

Central contacts

Lauren Gibson, MD

617-726-3030legibson@mgh.harvard.edu

Jordan Bloom, MD, MPH

617-643-6058jpbloom@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Jordan Bloom, MD, MPH

617-643-6058jpbloom@mgh.harvard.edu

Lauren Gibson, MD

legibson@mgh.harvard.edu

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Nov 10, 2026

Last verified

Oct, 2026

Keywords

  • Extubation
  • Cardiac surgery
  • Cardiac surgery recovery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-11. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-11-10. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.