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Not Yet Recruiting
NCT07757880
Randomized Evaluation of Operating Room Extubation After Cardiac Surgery
Conditions: Cardiac Surgery
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 120
Sponsor: Massachusetts General Hospital
Location: Brigham and Women's Hospital Boston Massachusetts
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07757880). StuddyBuddy aggregates publicly available trial information.