Planned Operating-Room Extubation After Cardiac Surgery

• Planned Operating-Room Extubation (Procedure), also known as ultra-fast track, Operating-Room Extubation (ORE): Planned operating-room extubation following adult cardiac surgery, delivered within an enhanced-recovery pathway. Participants will be extubated before leaving the operating room when routine clinical readiness criteria are met; if immediate extubation is considered unsafe, a prespecified safety override allows transfer to the ICU while remaining intubated.
• Standard Early ICU Extubation (Procedure): Participants randomized to the control arm will leave the operating room intubated and undergo tracheal extubation after transfer to the ICU or postoperative care unit according to usual enhanced-recovery practice. Extubation will be targeted within 6 hours after surgery when clinically appropriate. Sedation, analgesia, respiratory support, hemodynamic management, and other perioperative care will remain clinician-directed according to local practice.

Primary outcomes

• Organ Support-Free Hours to 72 Hours (OSFH-72) [First 72 hours after ICU admission following surgery]: Total number of hours during the first 72 hours after ICU admission that the participant is alive and free from qualifying respiratory support and clinically significant vasoactive or inotropic support. Qualifying respiratory support includes invasive mechanical ventilation and rescue NIV or HFNO used for respiratory failure. Hemodynamic support is considered present when the Vasoactive-Inotropic Score (VIS) is ≥5. Each fixed 60-minute epoch is classified as support present if qualifying respiratory or hemodynamic support is present for at least 30 minutes. Participants who die within the first 72 hours are assigned OSFH-72 = 0. Higher values indicate faster recovery.

Secondary outcomes

• Safety-First Hierarchical Win Ratio [Through 30 days after surgery]: Pairwise comparison of participants randomized to planned operating-room extubation versus standard ICU extubation using the following prespecified hierarchy: (1) all-cause death within 30 days; (2) stroke within 7 days or during the index hospitalization; (3) reoperation for bleeding or cardiac tamponade within 7 days or during the index hospitalization; (4) extubation failure due to respiratory failure within 72 hours of extubation, defined as unplanned reintubation or rescue NIV/HFNO; (5) unplanned ICU readmission within 7 days or during the index hospitalization; and (6) OSFH-72 if all higher-priority tiers are tied. The overall effect will be summarized as a stratified win ratio with 95% confidence intervals.

Other outcomes

• Quality of Recovery-15 (QoR-15) [baseline and 48 ±12 h after ICU admission]: QoR-15 total score (range 0-150), with higher scores representing better postoperative recovery. Assessed preoperatively and at 48 ±12 hours after ICU admission.
• Postoperative Pulmonary Complications [index hospitalization]
• Delirium [first 72 postoperative hours]
• Acute Kidney Injury / Renal Replacement Therapy [index hospitalization]
• Time to First Mobilization [index hospitalization]
• Time to Liberation From Supplemental Oxygen [index hospitalization]
• Days Alive and Out of Hospital at 30 Days (DAOH-30) [30 days]: Number of days during the first 30 days after surgery that the participant is alive and not hospitalized. Participants who die within 30 days are assigned a value of 0. Range 0-30; higher values are favorable.
• PROMIS-29 [baseline and 30 days]: Patient-reported physical, mental and social health assessed using PROMIS-29 domain T-scores and pain intensity, collected preoperatively and 30 days after surgery.
• Postoperative Atrial Fibrillation/Flutter [index hospitalization]
• Major Adverse Cardiovascular Events at 30 Days [30 days]
• ICU Length of Stay [Index hospitalization]
• Hospital Length of Stay [Index hospitalization]

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Age ≥18 years.
* Decision-making capacity and ability to provide written informed consent.
* Elective or urgent non-salvage cardiac surgery at a participating centre.

Undergoing an eligible cardiac surgical procedure requiring cardiopulmonary bypass via median sternotomy, including:

i) Isolated coronary artery bypass grafting (CABG), with or without MAZE procedure, pulmonary vein isolation (PVI), and/or left atrial appendage (LAA) occlusion.

ii) Isolated valve surgery (aortic, mitral, tricuspid, or pulmonary; repair or replacement), with or without MAZE/PVI/LAA occlusion.

iii) Combined CABG and valve surgery. iv) Selected limited aortic procedures, including Bentall procedure, valve-sparing root surgery, or isolated ascending aortic repair, with or without MAZE/PVI/LAA occlusion.

Exclusion Criteria:

* Emergent salvage surgery, including ongoing cardiopulmonary resuscitation, refractory cardiogenic shock requiring immediate surgery, or preoperative mechanical circulatory support.
* Preoperative invasive mechanical ventilation.
* Severe baseline respiratory disease making early extubation unlikely to be safe, including: i) Home oxygen use. ii) Known chronic hypercapnia. iii) COPD exacerbation requiring hospital or emergency department assessment, systemic corticosteroids, and/or antibiotics within the preceding 6 weeks.
* Anticipated difficult airway requiring planned awake intubation or advanced airway technique.
* Left ventricular ejection fraction <30%.
* Clinical Frailty Scale ≥5.
* Severe neurologic impairment that would preclude safe early extubation or reliable postoperative delirium assessment.
* Inability to complete core outcome assessments because of language or communication barriers when no interpreter is available.
* Surgery involving the aortic arch, deep hypothermic circulatory arrest, antegrade or retrograde cerebral perfusion, thoracoabdominal aortic aneurysm repair, mechanical circulatory support implantation, or heart transplantation.
* Minimally invasive cardiac surgery.
* Cardiac surgery not requiring cardiopulmonary bypass (off-pump surgery).
* Pregnancy.

• David Mazer, Study director, Departments of Anesthesiology and Pain Medicine, Physiology, and Pharmacology and Toxicology at the University of Toronto
• Subodh Verma, MD PhD, Study director, Departments of Surgery, and Pharmacology and Toxicology at the University of Toronto