Planned Operating-Room Extubation After Cardiac Surgery

NCT07874607 · tracked via the Priya Life Science Canada tracker

Sponsor

Nova Scotia Health Authority

Phase

Not applicable

Started

2026-11-01

Last updated

2026-10-15

Condition(s) studied

Mechanical VentilationCardiac SurgeryFast Track Program,(Enhanced Recovery After Surgery (ERAS))

Investigational drug(s) / intervention(s)

Planned Operating-Room ExtubationStandard Early ICU Extubation

Planned Operating-Room Extubation: 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: 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.

Study summary

The goal of this clinical trial is to learn whether removing the breathing tube in the operating room after cardiac surgery helps adults recover faster than removing the breathing tube later in the intensive care unit (ICU), without increasing the risk of complications. The main questions it aims to answer are:

* Does planned operating-room extubation increase the amount of time patients are alive and free from breathing-machine support and significant blood-pressure or heart-support medications during the first 72 hours after surgery?
* Is planned operating-room extubation as safe as standard early ICU extubation with respect to important complications such as death, stroke, reoperation for bleeding, breathing failure requiring additional support or reintubation, and unplanned ICU readmission? Researchers will compare planned operating-room extubation with standard enhanced-recovery care in which patients remain intubated when leaving the operating room and are extubated in the ICU, with a target of within 6 hours after surgery when clinically appropriate.

Participants will:

* Provide informed consent before surgery
* Be randomly assigned to one of the two extubation strategies
* Receive otherwise standard cardiac surgical, anesthesia, and ICU care
* Have routine clinical information collected during the first 72 hours after surgery and through hospital discharge
* Complete a short questionnaire about their recovery on postoperative day 2
* Have their health status followed to 30 days after surgery If a participant assigned to operating-room extubation develops a clinical concern that makes immediate extubation unsafe, the treating team may keep the breathing tube in place and transfer the participant to the ICU while continuing standard care.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

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.

Trial sites (2)

Facility	City	Region	Status
QEII Health Sciences Centre	Halifax	Nova Scotia
St. Michael's Hospital	Toronto	Ontario

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07874607 on ClinicalTrials.gov ↗ ← All trials in Canada