Optimal Interval for Periodic Alveolar Recruitment Maneuvers Achieving 90% Lung Re-expansion During Intraoperative Ventilation
Enrolling by invitation · Not applicable
Conditions studied: Major Abdominal Surgery, Atelectasis, Lung-protective Ventilation, Lung Ultrasound Score, Postoperative Pulmonary Complications
In brief
This study aims to determine the optimal interval for periodic alveolar recruitment maneuvers (PARM) that can achieve effective lung re-expansion in 90% of patients undergoing intraoperative mechanical ventilation during abdominal laparoscopic surgery in the low Trendelenburg position. Identifying the most effective frequency of PARM is crucial for establishing lung-protective ventilation strategies, with the ultimate goal of reducing intraoperative atelectasis, decreasing postoperative pulmonary complications, and accelerating recovery. Patients are randomized using a biased-coin sequential design. PARM is initially applied every 0.5 hours, and the effectiveness of lung re-expansion is evaluated before the end of surgery. The primary outcome is the effectiveness of recruitment, assessed by a combination of lung ultrasound scores and shunt fraction. Secondary outcomes include mechanical power at the end of surgery, time-weighted average mechanical power during ventilation, postoperative P/F ratio, dead space fraction, air test results, intraoperative adverse events, incidence of respiratory failure in the PACU and postoperative period, and postoperative length of stay. This trial is expected to provide robust evidence for defining the optimal RM interval in protective ventilation protocols for patients undergoing laparoscopic abdominal surgery, thereby contributing to improved perioperative respiratory outcomes.
Key facts
- Study ID
- NCT07239557
- Run by
- Sixth Affiliated Hospital, Sun Yat-sen University
- People needed
- 52
- Starts
- 2025-12-10
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-05-15
Who can join
Age: 65 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 65-80 years
- Undergoing elective laparoscopic anterior resection (expected mechanical ventilation duration 2-5 hours)
- Intermediate risk for postoperative pulmonary complications
- Room air SpO₂ ≥94%
You may not qualify if…
- History of pneumonia within 1 month or mechanical ventilation ≥1 hour
- Preoperative 12-zone LUS with any single zone score ≥2
- Preoperative shunt fraction ≥10%
- Progressive neuromuscular disease
- Severe emphysema/COPD or subpleural bullae ≥2 cm
- Intracranial hypertension
- Participation in other studies or refusal to participate
Where it is running
- SixthSunYetSen — Guangzhou, Guangdong, China
Full record on ClinicalTrials.gov
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