Cardiac Surgery
Conditions
Keywords
Extubation, Cardiac surgery, Cardiac surgery recovery
Brief 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.
Detailed description
This is a pragmatic, randomized controlled trial comparing OR extubation versus ICU extubation among adults undergoing elective cardiac surgery.
Interventions
PROCEDUREOR extubation
Immediate extubation in the operating room (OR) at the conclusion of cardiac surgery
PROCEDUREICU extubation
Extubation in the intensive care unit (ICU) within 6 hours of leaving the operating room after cardiac surgery
Sponsors
Massachusetts General Hospital
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hierarchical composite endpoint, ordered by clinical priority | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative ICU length of stay | 30 days | Cumulative length of stay (hours) in an intensive care unit (ICU) following cardiac surgery |
| Postoperative hospital length of stay | 30 days | Length of index hospitalization (hours) following cardiac surgery |
| Use of non-invasive respiratory support | 48 hours | Use of non-invasive respiratory support such as biPAP, CPAP, or high flow oxygen after OR exit |
Countries
United States
Contacts
CONTACTLauren Gibson, MD
CONTACTJordan Bloom, MD, MPH
Outcome results
None listed