Single-step versus stepwise lung inflation after cardiopulmonary bypass
Official title: Comparison of Hemodynamic and Pulmonary Outcomes Between Single-Step and Stepwise Lung Recruitment Maneuvers After Cardiopulmonary Bypass: A Randomized Controlled Trial
Run by Ondokuz Mayıs University · NCT07432477 · Data updated 2026-11-12
This study will test whether a single sustained lung inflation or a gradual stepwise inflation better preserves cardiac output and re-expands collapsed lung areas in adults undergoing elective open-heart surgery with cardiopulmonary bypass.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 52 (estimated) |
| Sponsor | Ondokuz Mayıs University Academic / other |
| Locations | 1 site (Samsun) |
| Status | Recruiting |
| Started | February 15, 2026 |
| Main results expected | February 1, 2027 |
| Study ends | May 1, 2027 |
| Registry record updated | July 1, 2026 |
| Trial ID | NCT07432477 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18–80 undergoing elective coronary artery bypass grafting or valve replacement with ASA II–IV, left ventricular ejection fraction ≥35%, and no severe chronic lung disease or hemodynamic instability.
✕Probably not a fit
Patients undergoing emergency surgery or with severe heart failure, low ejection fraction, high pulmonary artery pressure, significant chronic lung disease, pneumothorax, or ongoing hemodynamic instability are unlikely to benefit and are excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In this randomized controlled trial, adult patients having elective open-heart surgery with cardiopulmonary bypass will be randomized after separation from bypass to receive either a single-step sustained inflation recruitment maneuver or a stepwise incremental recruitment maneuver, both combined with 8 cmH2O positive end-expiratory pressure. Hemodynamic variables, primarily cardiac index, will be measured immediately before and after the recruitment maneuver to capture acute effects on cardiac output. Pulmonary effects will be evaluated with lung ultrasound atelectasis scoring and arterial blood gas analysis. The goal is to identify which recruitment strategy restores lung aeration effectively while preserving hemodynamic stability in this high-risk postoperative population.
Why it matters
Potential benefit: If successful, the preferred maneuver could reduce postoperative atelectasis while avoiding harmful drops in cardiac output, potentially improving oxygenation and clinical recovery after cardiac surgery.
How similar studies have gone: Lung recruitment maneuvers have shown benefit for aeration and oxygenation in perioperative settings, but evidence on hemodynamic safety after cardiopulmonary bypass is limited and direct comparisons of single-step versus stepwise approaches are sparse.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-80 years * ASA (American Society of Anesthesiologists) II-IV * Patients undergoing elective cardiac surgery (coronary artery bypass grafting, mitral valve replacement, aortic valve replacement) Exclusion Criteria: * Emergency surgery * Presence of perioperative arrhythmia * \<35% left ventricular ejection fraction * \>50 mmHg systolic pulmonary artery pressure * Known chronic obstructive pulmonary disease or interstitial lung disease * Pneumothorax * Mean arterial pressure \<60 mmHg during recruitment maneuver * New York Heart Association (NYHA) class III-IV heart failure * Advanced cardiomyopathy or severe mitral regurgitation * Cross-clamp time longer than 2 hours * Requirement for high-dose inotropic or vasopressor support * Patients who cannot be extubated after postoperative 24 hours
Where it's running
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Ondokuz Mayıs University, Faculty of Medicine
Samsun, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: Burhan Dost, MD
- Email: burhandost@hotmail.com
- Phone: +903623121919
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.