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NCT07874607

Planned Operating-Room Extubation After Cardiac Surgery

Sponsor: Nova Scotia Health Authority

View on ClinicalTrials.gov

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.

Official title: BREATHE Trial: A Multicenter Randomized Trial of Planned Operating-Room Extubation and Early Postoperative Recovery After Cardiac Surgery

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

336

Start Date

2026-11-01

Completion Date

2028-12

Last Updated

2026-10-15

Healthy Volunteers

Conditions

Mechanical Ventilation Cardiac Surgery Fast Track Program,(Enhanced Recovery After Surgery (ERAS))

Interventions

PROCEDURE

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.

PROCEDURE

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.

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.

Locations (2)

QEII Health Sciences Centre

Halifax, Nova Scotia, Canada

St. Michael's Hospital

Toronto, Ontario, Canada