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Vilon

KE, L-Lys-L-Glu, lysylglutamic acid

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Studies 40
Trials 100
Not Yet Recruiting NA INTERVENTIONAL NCT07239557

Optimal Interval for Periodic Alveolar Recruitment Maneuvers Achieving 90% Lung Re-expansion During Intraoperative Ventilation

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

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.

Detailed Description

This study is designed to evaluate the optimal interval of periodic alveolar recruitment maneuvers (PARM) to achieve effective lung re-expansion (defined as LUS ≤1 and shunt fraction \<10%) in 90% of elderly patients undergoing laparoscopic anterior resection in low Trendelenburg position. This is a single-arm, biased-coin sequential design study. The initial PARM interval is 30 min, adjusted in 10 min increments based on response. The primary outcome is recruitment efficacy. Secondary outcomes include intraoperative mechanical power, P/F ratio, postoperative pulmonary complications, and length of hospital stay. This study aims to inform optimal RM intervals in protective ventilation protocols.

Interventions

Name: Different interval of PARM
Type: PROCEDURE
Description: The initial time interval of PARM was 0.5 hours/time, and the different interval of PARM was assigned by random partial coin sequential method.If the previous patient did not respond to postoperative assessment of lung opening, the interval between expansion of the lungs was shortened by 10 minutes for the next patient; If lung opening is effective, there is an 11% chance that the next patient will have an 10-minute expansion interval and an 89% chance that the time interval will remain unchanged.

Primary Outcomes

Measure: The effectiveness of recruitment
TimeFrame: Intraoperative
Description: The effectiveness of recruitment assessed by a combination of lung ultrasound scores and shunt fraction。At the end of surgery (with the patient in the supine position, after at least 5 minutes of apnea under mechanical ventilation without spontaneous breathing, and at the specified interval since the last recruitment maneuver), a lung ultrasound examination was performed. Lung re-expansion was considered effective if the 12-zone lung ultrasound score (LUS) was ≤1 per zone and the shunt fraction was \<10%.

Trial Information

NCT ID

NCT07239557

Status

Not Yet Recruiting

Study Type

INTERVENTIONAL

Phases

NA

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Last Updated

December 15, 2025