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NCT Number: NCT07757880

Randomized Evaluation of Operating Room Extubation After Cardiac Surgery

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital, Boston, Massachusetts, United States

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About this study

This is a pragmatic, randomized controlled trial comparing OR extubation versus ICU extubation among adults undergoing elective cardiac surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OR extubation

Procedure

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

ICU extubation

Procedure

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

Primary outcomes

  1. Hierarchical composite endpoint, ordered by clinical priority

    Time frame: 15 days postoperatively

    • Death by postoperative day 15;
    • Unplanned reintubation or cumulative mechanical ventilation > 12 hours from OR exit, assessed through 48 hours postoperatively;
    • 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.

Secondary outcomes

  1. Postoperative ICU length of stay

    Time frame: 30 days

    Cumulative length of stay (hours) in an intensive care unit (ICU) following cardiac surgery

  2. Postoperative hospital length of stay

    Time frame: 30 days

    Length of index hospitalization (hours) following cardiac surgery

  3. Use of non-invasive respiratory support

    Time frame: 48 hours

    Use of non-invasive respiratory support such as biPAP, CPAP, or high flow oxygen after OR exit

Study contacts

Contact information is provided by the study sponsor or research team.

Jordan Bloom, MD, MPH

CONTACT

[email protected]

617-643-6058

Lauren Gibson, MD

CONTACT

[email protected]

617-726-3030

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Brigham and Women's Hospital

Registry information

Official study title

Randomized Evaluation of Operating Room Extubation Versus Intensive Care Unit Extubation After Cardiac Surgery

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 11, 2026
Registry last updated
Aug 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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