An interventional study of Planned Operating-Room Extubation and Standard Early ICU Extubation in Mechanical Ventilation, Cardiac Surgery and Fast Track Program,(Enhanced Recovery After Surgery (ERAS)), sponsored by Nova Scotia Health Authority. Not yet recruiting at 2 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Nova Scotia Health Authority · Not applicable, Interventional, and Supportive care
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:
Participants will:
Nova Scotia Health Authority is the lead sponsor of 264 studies on the registry; 80 are open to participants now.
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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:
Standardized enhanced recovery after cardiac surgery anesthetic approach with patient extubated in the operating room once criteria for extubation are met
Procedure: Planned Operating-Room Extubation
Intubated patient transferred to ICU (or PACU); Extubated after leaving the OR, per usual enhanced recovery clinical practice (extubated within ≤ 6 h post-surgery).
Procedure: Standard Early ICU 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.
Also known as: ultra-fast track, Operating-Room Extubation (ORE)
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.
Organ Support-Free Hours to 72 Hours (OSFH-72)
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.
Time frame: First 72 hours after ICU admission following surgery
Safety-First Hierarchical Win Ratio
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.
Time frame: Through 30 days after surgery
Quality of Recovery-15 (QoR-15)
QoR-15 total score (range 0-150), with higher scores representing better postoperative recovery. Assessed preoperatively and at 48 ±12 hours after ICU admission.
Time frame: baseline and 48 ±12 h after ICU admission
Postoperative Pulmonary Complications
Time frame: index hospitalization
Delirium
Time frame: first 72 postoperative hours
Acute Kidney Injury / Renal Replacement Therapy
Time frame: index hospitalization
Time to First Mobilization
Time frame: index hospitalization
Time to Liberation From Supplemental Oxygen
Time frame: index hospitalization
Days Alive and Out of Hospital at 30 Days (DAOH-30)
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.
Time frame: 30 days
PROMIS-29
Patient-reported physical, mental and social health assessed using PROMIS-29 domain T-scores and pain intensity, collected preoperatively and 30 days after surgery.
Time frame: baseline and 30 days
Postoperative Atrial Fibrillation/Flutter
Time frame: index hospitalization
Major Adverse Cardiovascular Events at 30 Days
Time frame: 30 days
ICU Length of Stay
Time frame: Index hospitalization
Hospital Length of Stay
Time frame: Index hospitalization
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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