๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-08-06

Randomized Evaluation of Operating Room Extubation After Cardiac Surgery (NCT07757880)

๐ŸŸก Not Yet Recruiting Observational / Diagnostic ๐Ÿฉบ Clinical Procedure Protocol Sponsor: Massachusetts General Hospital

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (10 items).

Location: Brigham and Women's Hospital โ€” Boston, Massachusetts

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Underlying pulmonary disease requiring use of home supplemental oxygen
  • Pre-capillary pulmonary hypertension (mPAP โ‰ฅ 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

๐Ÿ” Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

๐Ÿ“ All Participating Trial Locations (2 Sites)

  • Brigham and Women's Hospital โ€” Boston, Massachusetts
  • Massachusetts General Hospital โ€” Boston, Massachusetts

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
๐Ÿ›๏ธ View Official NIH Record โ†—