Randomized Evaluation of Operating Room Extubation After Cardiac Surgery

NCT07757880 | Not Yet Recruiting

• 1 other identifier: 2026P000935
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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

Keywords

Extubation; Cardiac surgery; Cardiac surgery recovery

Outcome Measures

Primary Outcomes (1)

• Hierarchical composite endpoint, ordered by clinical priority

  1. Death by postoperative day 15; 2. Unplanned reintubation or cumulative mechanical ventilation \> 12 hours from OR exit, assessed through 48 hours postoperatively; 3. 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.

  15 days postoperatively

Secondary Outcomes (3)

• Postoperative ICU length of stay

  30 days

• Postoperative hospital length of stay

  30 days

• Use of non-invasive respiratory support

  48 hours

Study Arms (2)

OR extubation

ACTIVE COMPARATOR

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

Procedure: OR extubation

ICU extubation

PLACEBO COMPARATOR

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

Procedure: ICU extubation

Interventions

OR extubation PROCEDURE

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

OR extubation

ICU extubation PROCEDURE

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

ICU extubation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Brigham and Women's Hospital: collaborator

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02141, United States

Location

MeSH Terms

Interventions

Airway Extubation

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Investigative Techniques

Central Study Contacts

Lauren Gibson, MD

CONTACT

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

Jordan Bloom, MD, MPH

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiac anesthesiologist

Model Details: Participants will be randomly assigned to either: * Arm 1 (OR extubation): Extubation in the operating room within 1 hour of procedure completion, unless prespecified intraoperative contraindications are met (see below); * Arm 2 (ICU extubation): Extubation in the ICU within 6 hours of leaving the operating room, consistent with current STS quality-metric standards, unless prespecified exclusion criteria are met.

Study Record Dates

• First Submitted: August 6, 2026
• First Posted: August 11, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: August 11, 2026

Record last verified: 2026-08

Locations

US (2)