Prophylactic Use of APRV Before Extubation in Morbidly Obese Patients After Cardiac Surgery. (NCT07409324) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Prophylactic Use of APRV Before Extubation in Morbidly Obese Patients After Cardiac Surgery.
180 participantsStarted 2026-02-01
Plain-language summary
Morbidly obese patients undergoing open heart surgery are at increased risk of breathing problems after removal of the breathing tube due to reduced lung function and chest wall restriction following surgery. These complications may result in poor oxygenation, respiratory failure, and prolonged ICU stay.
Airway Pressure Release Ventilation (APRV) is a mechanical ventilation mode that improves lung recruitment and oxygenation. This study aims to evaluate whether the prophylactic use of APRV after ICU admission, compared with conventional lung-protective mechanical ventilation, improves oxygenation, lung function, and ICU outcomes in morbidly obese patients undergoing elective cardiac surgery.
Patients will be randomly assigned to receive either APRV or conventional ventilation during postoperative mechanical ventilation, followed by standard weaning and extubation. Outcomes include oxygenation index, lung ultrasound findings, need for reintubation, and ICU clinical outcomes.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Adult patients aged 18-65 year of both sex.
Morbidly obese patients (body mass index ≥ 40 kg/m² or ≥ 35 kg/m² with obesity-related comorbidities)
Scheduled for elective cardiac surgery (CABG, valve, or combined) requiring cardiopulmonary bypass
Planned postoperative admission to the cardiac surgical intensive care unit
Patients eligible for mechanical ventilation with planned early extubation within 6-12 hours postoperatively
Ability to provide written informed consent
Exclusion Criteria:
Severe pulmonary disease (e.g., COPD GOLD III/IV, home oxygen therapy, and pulmonary fibrosis).
Patients with history of previous spontaneous pneumothorax or postoperative pneumothorax.
Intracranial hypertension or contraindication to APRV. Hemodynamically unstable on admission (MAP less than 65 mmHg) Vasopressor/inotropic score (VIS) more than 10 Requirement for postoperative extracorporeal membrane oxygenation (ECMO) or intra-aortic balloon pump (IABP).
Inability to obtain informed consent
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing a specific ventilator mode called APRV before removing the breathing tube in morbidly obese patients after cardiac surgery — is this something that might be relevant to my situation, and what does my care team currently do at that stage of my recovery?
2The trial is measuring something called the Oxygenation Index to see how well patients are breathing after surgery — can you explain what that number means for someone like me, and how my weight might affect my breathing risks after cardiac surgery?
3Since this study is listed as 'not yet recruiting,' it may not be available when I need surgery — are there other ventilation strategies or protocols already in use at this hospital that address breathing complications in heavier patients after heart surgery?
4This trial is listed as Phase NA, which often means it's studying a procedure or device rather than a drug — does that change anything about what's known regarding safety, and would participating in this kind of study affect the standard care I'd otherwise receive?
5Given that morbid obesity is a specific focus of this trial, how concerned are you about my respiratory recovery after cardiac surgery, and are there steps we should be planning for regardless of whether this trial becomes available to me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Oxygenation Index (OI)
Timeframe: o Immediately before APRV initiation o 1 hour before extubation o 1 hour post-extubation o 6 hours post extubation o 24 hours post extubation