Cardiac SurgeryNCT07757880
Randomized Evaluation of Operating Room Extubation After Cardiac Surgery
A study testing OR extubation and ICU extubation in people with Cardiac Surgery, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
We are studying whether waking patients up and removing the breathing tube (also known as "extubation") in the operating room after cardiac surgery improves postoperative recovery without causing harm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- OR extubation and ICU extubation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2026to Jun 2027
- 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
- Adults (age 18+) scheduled for elective cardiac surgery requiring cardiopulmonary bypass
- Low perioperative risk defined as STS Predicted Risk of Mortality (PROM) ≤ 3% based on the latest STS Adult Cardiac Surgery Database (ACSD) Risk Calculator
- Deemed appropriate for OR extubation preoperatively by the attending cardiac surgeon
- Able to provide informed consent
Who cannot join
- Underlying pulmonary disease requiring use of home supplemental oxygen
- Pre-capillary pulmonary hypertension (mPAP ≥ 25 mmHg or PVR > 2 Wood units) on most recent right heart catheterization for any patient for which there is suspicion for pulmonary hypertension at the time of preoperative evaluation
- Preoperative right ventricular dysfunction greater than mild on most recent echocardiogram
- BMI ≥ 35
- Obstructive sleep apnea with home CPAP or biPAP use or recommended use
- Neuromuscular disease associated with respiratory muscle weakness including myasthenia gravis, Lambert-Eaton myasthenic syndrome, or muscular dystrophy
Show all 11Show fewer
- Airway abnormalities including tracheostomy, history of difficult mask ventilation, history of difficult intubation requiring fiberoptic rescue or multiple (>2) attempts, known anatomic abnormalities including limited mouth opening (< 3cm), severe micrognathia, tracheal stenosis, or tracheal compression due to mass or goiter
- We will also exclude patients undergoing the following procedures:
- Transplant surgery
- Pulmonary thromboendarterectomy
- Implantation of mechanical circulatory support including LVAD, Impella, intra-aortic balloon pump, RVAD, or ECMO
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Jordan Bloom, MD, MPH, 617-643-6058, jpbloom@mgh.harvard.edu
Lauren Gibson, MD, legibson@mgh.harvard.edu
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Chinyere Archie, MBBS, 617-732-8210, carchie1@bwh.harvard.edu
Margaret Connolly, MD, mrconnolly@mgb.org
About this study
Official title: Randomized Evaluation of Operating Room Extubation Versus Intensive Care Unit Extubation After Cardiac Surgery
We are studying whether waking patients up and removing the breathing tube (also known as "extubation") in the operating room after cardiac surgery improves postoperative recovery without causing harm.
Read the detailed description
This is a pragmatic, randomized controlled trial comparing OR extubation versus ICU extubation among adults undergoing elective cardiac surgery.
- Conditions
- Cardiac Surgery
- Being tested
- OR extubation, ICU extubation
- Keywords
- Extubation, Cardiac surgery, Cardiac surgery recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OR extubationProcedure or surgery
Immediate extubation in the operating room (OR) at the conclusion of cardiac surgery
ICU extubationProcedure or surgery
Extubation in the intensive care unit (ICU) within 6 hours of leaving the operating room after cardiac surgery
| Study group | Role | What they receive |
|---|---|---|
| OR extubation | Active comparator | Extubation in the operating room (OR) at the conclusion of cardiac surgery Receives: Procedure: OR extubation |
| ICU extubation | Placebo comparator | Extubation in the intensive care unit (ICU) within 6 hours of leaving the OR Receives: Procedure: ICU extubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hierarchical composite endpoint, ordered by clinical priority
- Death by postoperative day 15;
- Unplanned reintubation or cumulative mechanical ventilation > 12 hours from OR exit, assessed through 48 hours postoperatively;
- Days at home through postoperative day 15 (DAH-15). DAH-15 will be measured from the time of post-operative ICU admission and will subtract any time spent in a hospital (index hospitalization or readmission), rehabilitation center, or nursing facility.
Measured: 15 days postoperatively
Secondary outcomes (3)
Postoperative ICU length of stay
Cumulative length of stay (hours) in an intensive care unit (ICU) following cardiac surgery
Measured: 30 days
Postoperative hospital length of stay
Length of index hospitalization (hours) following cardiac surgery
Measured: 30 days
Use of non-invasive respiratory support
Use of non-invasive respiratory support such as biPAP, CPAP, or high flow oxygen after OR exit
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study startOct 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to either: * Arm 1 (OR extubation): Extubation in the operating room within 1 hour of procedure completion, unless prespecified intraoperative contraindications are met (see below); * Arm 2 (ICU extubation): Extubation in the ICU within 6 hours of leaving the operating room, consistent with current STS quality-metric standards, unless prespecified exclusion criteria are met.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Responsible party
- Principal investigator, Lauren E Gibson, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07757880
- Sponsor's protocol ID
- 2026P000935
- Status last verified
- Oct 2026
- First submitted
- 6 Aug 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- 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 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Evaluation of Operating Room Extubation Versus Intensive Care Unit Extubation After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT07757880
- Acronym / sponsor ID
- 2026P000935
- Conditions
- Cardiac Surgery
- Keywords
- Extubation, Cardiac surgery, Cardiac surgery recovery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Study start
- Oct 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 11 Aug 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.
We are studying whether waking patients up and removing the breathing tube (also known as "extubation") in the operating room after cardiac surgery improves postoperative recovery without causing harm.
Detailed description
This is a pragmatic, randomized controlled trial comparing OR extubation versus ICU extubation among adults undergoing elective cardiac surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either: * Arm 1 (OR extubation): Extubation in the operating room within 1 hour of procedure completion, unless prespecified intraoperative contraindications are met (see below); * Arm 2 (ICU extubation): Extubation in the ICU within 6 hours of leaving the operating room, consistent with current STS quality-metric standards, unless prespecified exclusion criteria are met.
| Arm | Type | Receives |
|---|---|---|
| OR extubation | Active comparator | Procedure: OR extubationExtubation in the operating room (OR) at the conclusion of cardiac surgery |
| ICU extubation | Placebo comparator | Procedure: ICU extubationExtubation in the intensive care unit (ICU) within 6 hours of leaving the OR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults (age 18+) scheduled for elective cardiac surgery requiring cardiopulmonary bypass
- Low perioperative risk defined as STS Predicted Risk of Mortality (PROM) ≤ 3% based on the latest STS Adult Cardiac Surgery Database (ACSD) Risk Calculator
- Deemed appropriate for OR extubation preoperatively by the attending cardiac surgeon
- Able to provide informed consent
Key exclusion criteria (11 listed)
- Underlying pulmonary disease requiring use of home supplemental oxygen
- Pre-capillary pulmonary hypertension (mPAP ≥ 25 mmHg or PVR > 2 Wood units) on most recent right heart catheterization for any patient for which there is suspicion for pulmonary hypertension at the time of preoperative evaluation
- Preoperative right ventricular dysfunction greater than mild on most recent echocardiogram
- BMI ≥ 35
- Obstructive sleep apnea with home CPAP or biPAP use or recommended use
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 |
|---|---|---|
| OR extubationImmediate extubation in the operating room (OR) at the conclusion of cardiac surgery | Procedure or surgery | OR extubation |
| ICU extubationExtubation in the intensive care unit (ICU) within 6 hours of leaving the operating room after cardiac surgery | Procedure or surgery | ICU extubation |
Primary outcome
Hierarchical composite endpoint, ordered by clinical priority
Time frame: 15 days postoperatively
1. Death by postoperative day 15; 2. Unplanned reintubation or cumulative mechanical ventilation > 12 hours from OR exit, assessed through 48 hours postoperatively; 3. Days at home through postoperative day 15 (DAH-15). DAH-15 will be measured from the time of post-operative ICU admission and will subtract any time spent in a hospital (index hospitalization or readmission), rehabilitation center, or nursing facility.
3 secondary outcomes
Postoperative ICU length of stay
Time frame: 30 days
Postoperative hospital length of stay
Time frame: 30 days
Use of non-invasive respiratory support
Time frame: 48 hours
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 29 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OR extubation and ICU extubation in people with Cardiac Surgery, run by Massachusetts General Hospital at 2 sites in United States.
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 4 inclusion and 11 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 29 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 United States. 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. Some participants in this study may receive a placebo. 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 Lauren Gibson, MD (617-726-3030, legibson@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hierarchical composite endpoint, ordered by clinical priority (time frame: 15 days postoperatively). 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 29 Oct 2026.