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Randomized Evaluation of Operating Room Extubation After Cardiac Surgery

Randomized Evaluation of Operating Room Extubation After Cardiac Surgery

Recruiting
18 years and older
All
Phase N/A

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Overview

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.

Description

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

Eligibility

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 details
    Cardiac Surgery

NCT07757880

Massachusetts General Hospital

14 November 2026

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