The Influence of Individualized Intraoperative PEEP After Alveolar Recruitment Maneuvres on the Incidence of Postoperative Respiratory Complications Following Laparoscopic Abdominal Surgery. A Prospective Randomized Controlled Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- Respiratory complications
研究概览
简要总结
Patients ASA I-III, undergoing laparoscopic abdominal surgery will be randomly assigned, into one of two groups, namely group C-PEEP , that will be the control group ; and group I-PEEP, where alveolar recruitment maneuvres will take place in order to identify each patient's individualized optimal PEEP. All patients will receive a standardized anesthesia regimen. The lung ultrasound score will be evaluated in all patients in the PACU and then respiratory complications will be recorded on the 24th hour, 48th hour, 7th day and 30the day, postoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I-III Laparoscopic abdominal surgery
排除标准
- •Severe kidney dysfunction Severe hepatic dysfunction Severe respiratory disease Severe cardiac disease Severe neuromuscular disease BMI>30 Severe intraoperative hemorrage Severe intraoperative hemodynamic instability
结局指标
主要结局
Respiratory complications
时间窗: 30 days
Postoperative complications (atelectasis, bronchospasm, pneumonia, respiratory failure, ARDS, prolonged mechanical ventilations, reintubation, pleural infusion, COPD exacerbation)
次要结局
- Pplat(intraoperatively)
- SpO2(intraoperatively)
- PCO2(intraoperatively)
- PaO2/FiO2(intraoperatively)
- Cdyn(intraoperatively)
- MAP(intraoperatively)
- Ppeak(intraoperatively)
- heart rate(intraoperatively)
- LUS score(Preoperatively and 30 minutes postoperatively)
研究者
Alexandros Makris
Senior Consultant Anesthesiologist
Asklepieion Voulas General Hospital