Optimal Interval for Periodic Alveolar Recruitment Maneuvers Achieving 90% Lung Re-expansion During Intraoperative Mechanical Ventilation: A Randomized Biased-Coin Sequential Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- The effectiveness of recruitment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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%
排除标准
- •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
研究组 & 干预措施
PARM
干预措施: Different interval of PARM (Procedure)
结局指标
主要结局
The effectiveness of recruitment
时间窗: Intraoperative
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%.
次要结局
- The P/F ratio at the end of surgery,(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))
- Dead space rate(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))
- Air-breathing test(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))
- Intraoperative hypotension(During mechanical ventilation in the intraoperative period.)
- Intraoperative vasopressor use.(During intraoperative mechanical ventilation)
- Intraoperative mild hypoxemia(During intraoperative mechanical ventilation)
- Intraoperative severe hypoxemia(During intraoperative mechanical ventilation)
- Mechanical power 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)
- Time-weighted average mechanical power during surgery(During intraoperative mechanical ventilation)
- Lung ultrasound score (LUS) in the post-anesthesia care unit (PACU)(Awake with spontaneous breathing before discharge from the PACU)
- Rate of respiratory failure at post-anesthesia care unit (PACU)(Stay in the PACU for at least 20 minutes and at most 3 hours; assessed at 5 to 10 minutes before leaving PACU)
- Rate of postoperative respiratory failure(Day1 to 5 after surgery)
- Rate of sustained hypoxaemia(Day 1 to 5 after surgery)
- Postoperative pulmonary complications, Grades 1-4(Day 0 to 5 after surgery)
- Postoperative pulmonary complications, Grades 2-4(Day 0 to 5 after surgery)
- Pneumothorax(Day 0 to 7 after surgery)
- Postoperative hospitalization days(Day 0 to 30 after surgery)
- Unexpected admission to ICU(within 30 days after surgery)
- Death from any cause(Day 0 to 30 after surgery)