Single-step versus stepwise lung inflation after cardiopulmonary bypass
Comparison of Hemodynamic and Pulmonary Outcomes Between Single-Step and Stepwise Lung Recruitment Maneuvers After Cardiopulmonary Bypass: A Randomized Controlled Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Ondokuz Mayıs University Academic / other |
| Locations | 1 site (Samsun, Atakum) |
| Trial ID | NCT07432477 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Samsun, Atakum
- Ondokuz Mayıs University, Faculty of Medicine — Samsun, Atakum, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Burhan Dost, MD
- Email: burhandost@hotmail.com
- Phone: +903623121919
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.