Mechanical VentilationNCT07874607
Planned Operating-Room Extubation After Cardiac Surgery
A study testing Planned Operating-Room Extubation and Standard Early ICU Extubation in people with Mechanical Ventilation and Cardiac Surgery, run by Nova Scotia Health Authority at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation, Cardiac Surgery, Fast Track Program,(Enhanced Recovery After Surgery (ERAS))
- What is being tested?
- Planned Operating-Room Extubation and Standard Early ICU Extubation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 336 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Nov 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Isolated coronary artery bypass grafting (CABG), with or without MAZE procedure, pulmonary vein isolation (PVI), and/or left atrial appendage (LAA) occlusion.
- Isolated valve surgery (aortic, mitral, tricuspid, or pulmonary; repair or replacement), with or without MAZE/PVI/LAA occlusion.
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Ahmad Alli, MD contact
Canada2 sites
QEII Health Sciences Centre
Halifax, Nova Scotia, B3L 2Z5
Pieter de Jager, MD, 902-473-7736, Pieter.deJager@nshealth.ca
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Ahmad Alli, (416) 360-4000, ahmad.alli@unityhealth.to
About this study
Official title: BREATHE Trial: A Multicenter Randomized Trial of Planned Operating-Room Extubation and Early Postoperative Recovery After Cardiac Surgery
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.
Read more
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.
- Conditions
- Mechanical Ventilation, Cardiac Surgery, Fast Track Program,(Enhanced Recovery After Surgery (ERAS))
- Being tested
- Planned Operating-Room Extubation, Standard Early ICU Extubation
- Keywords
- Operating-room extubation, Early extubation, Cardiac surgery, Enhanced Recovery After Surgery, Organ support-free hours, Postoperative recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Planned Operating-Room ExtubationProcedure or surgery
Also called 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 ExtubationProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| Arm A: Planned Operating-Room Extubation (ORE) | Experimental | Standardized enhanced recovery after cardiac surgery anesthetic approach with patient extubated in the operating room once criteria for extubation are met Receives: Procedure: Planned Operating-Room Extubation |
| Arm B: Standard Early ICU Extubation | Active comparator | Intubated patient transferred to ICU (or PACU); Extubated after leaving the OR, per usual enhanced recovery clinical practice (extubated within ≤ 6 h post-surgery). Receives: Procedure: Standard Early ICU Extubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: First 72 hours after ICU admission following surgery
Secondary outcomes (1)
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.
Measured: Through 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completionNov 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 336 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Collaborators
- Unity Health Toronto
- Responsible party
- Sponsor
- Investigators
- David Mazer, Study director, Departments of Anesthesiology and Pain Medicine, Physiology, and Pharmacology and Toxicology at the University of TorontoSubodh Verma, MD PhD, Study director, Departments of Surgery, and Pharmacology and Toxicology at the University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07874607
- Sponsor's protocol ID
- BREATHE
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BREATHE Trial: A Multicenter Randomized Trial of Planned Operating-Room Extubation and Early Postoperative Recovery After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT07874607
- Acronym / sponsor ID
- BREATHE
- Conditions
- Mechanical Ventilation, Cardiac Surgery, Fast Track Program,(Enhanced Recovery After Surgery (ERAS))
- Keywords
- Operating-room extubation, Early extubation, Cardiac surgery, Enhanced Recovery After Surgery, Organ support-free hours, Postoperative recovery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 336 participants (estimated)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Collaborators
- Unity Health Toronto
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 15 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Planned Operating-Room Extubation (ORE) | Experimental | Procedure: Planned Operating-Room ExtubationStandardized enhanced recovery after cardiac surgery anesthetic approach with patient extubated in the operating room once criteria for extubation are met |
| Arm B: Standard Early ICU Extubation | Active comparator | Procedure: Standard Early ICU ExtubationIntubated patient transferred to ICU (or PACU); Extubated after leaving the OR, per usual enhanced recovery clinical practice (extubated within ≤ 6 h post-surgery). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- Isolated coronary artery bypass grafting (CABG), with or without MAZE procedure, pulmonary vein isolation (PVI), and/or left atrial appendage (LAA) occlusion.
Key exclusion criteria (12 listed)
- 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%.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Planned Operating-Room ExtubationAlso: 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. | Procedure or surgery | Arm A: Planned Operating-Room Extubation (ORE) |
| Standard Early ICU ExtubationParticipants 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. | Procedure or surgery | Arm B: Standard Early ICU Extubation |
Primary outcome
Organ Support-Free Hours to 72 Hours (OSFH-72)
Time frame: 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.
1 secondary outcome
Safety-First Hierarchical Win Ratio
Time frame: Through 30 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Mechanical Ventilation
Recruiting
Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Meconium Exposure
Neonatal Respiratory Distress Related Conditions, Meconium
Not yet recruitingObservational study
Intra-Abdominal Pressure, Respiratory Mechanics, and Ventilator Liberation After Emergency Major Laparotomy
Intra-Abdominal Hypertension, Respiratory Mechanics
Recruiting
Behavioral Economic & Staffing Strategies in the ICU
Implementation Science, Delirium
Not yet recruiting
Modified Inhaled Nitric Oxide in Ventilated Patients With Acute Respiratory Failure
Acute Respiratory Failure (ARF), Nitric Oxide
Recruiting
Titration of PS Guided by FI : A Pilot Study
Mechanical Ventilation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ahmad Alli, MD contact
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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Planned Operating-Room Extubation and Standard Early ICU Extubation in people with Mechanical Ventilation and Cardiac Surgery, run by Nova Scotia Health Authority at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pieter de Jager, MD (902-473-7736, Pieter.deJager@nshealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Organ Support-Free Hours to 72 Hours (OSFH-72) (time frame: First 72 hours after ICU admission following surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.