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Randomized Evaluation of Operating Room Extubation After Cardiac Surgery

ConditionCardiac Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • OR extubation

    Procedure/Surgery

    Immediate extubation in the operating room (OR) at the conclusion of cardiac surgery

  • ICU extubation

    Procedure/Surgery

    Extubation in the intensive care unit (ICU) within 6 hours of leaving the operating room after cardiac surgery

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: OR extubationActive comparator 1 intervention
Group B: ICU extubationPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Hierarchical composite endpoint, ordered by clinical priority

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.

Time frame
15 days postoperatively

Secondary outcomes

1

Postoperative ICU length of stay

Cumulative length of stay (hours) in an intensive care unit (ICU) following cardiac surgery

Time frame
30 days
2

Postoperative hospital length of stay

Length of index hospitalization (hours) following cardiac surgery

Time frame
30 days
3

Use of non-invasive respiratory support

Use of non-invasive respiratory support such as biPAP, CPAP, or high flow oxygen after OR exit

Time frame
48 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

Brigham and Women's Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: