Individualized Selection of PEEP in Patients Affected by Expiratory Flow Limitation: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,536
- 主要终点
- Postoperative pulmonary complications
研究概览
简要总结
The goal of this clinical trial is to compare different mechanical ventilation settings in Patients undergoing laparoscopic surgery and affected by Expiratory flow limitation. The main question[s] it aims to answer are:
- If individualizing mechanical ventilation on expiratory flow limitation can reduce pulmonary postoperative complications;
- If patients with expiratory flow limitation have a higher incidence of pulmonary postoperative complications as compared to patients with no expiratory flow limitation;
Participants will be screened for expiratory fow limitation and patients with positive screening will be randomized into two groups. Each group will receive a different intraoperative mechanical ventilation:
- Personalized positive end-expiratory pressure based on EFL
- Standard of care positive end-expiratory pressure
Researchers will then compare the two groups to see if the incidence of pulmonary postoperative complications in the first 7 days after surgery is different.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages between 18 and 90 years old;
- •Patients undergoing laparoscopic, robotic surgery
- •Surgery performed in elective regimen;
- •Length of mechanical ventilation more than 120 minutes;
- •Presence of invasive pressure monitoring for clinical purposes;
排除标准
- •Age < 18 or > 90;
- •Severe chronic obstructive pulmonary disease with GOLD stage 3 or 4;
- •Length of mechanical ventilation less than 120 minutes;
- •Unplanned conversion to laparotomy surgery;
- •Refusal to participate by the patient;
- •Anesthesia maintenance using Desflurane.
结局指标
主要结局
Postoperative pulmonary complications
时间窗: First 7 days after surgery
The investigators will evaluate the number of Pulmonary postoperative complications in the first 7 days after surgery
次要结局
- Need for intubation or non-invasive ventilation(First 7 days after surgery)
- Need for Intensive Care admission(From hospital entrance to hospital discharge, assessed up to 30 days)
- Postoperative Oxygenation(Within 2 hours after surgery)
- Days of hospitalization(From hospital entrance to hospital discharge, assessed up to 30 days)
- Length of stay in ICU(From intensive care entrance to intensive care discharge, assessed up to 30 days)
研究者
Savino Spadaro
Principal investigator
Università degli Studi di Ferrara