Driving Pressure During General Anesthesia for Minimally Invasive Abdominal Surgery (GENERATOR) - a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,806
- 试验地点
- 2
- 主要终点
- Proportion of participants developing one or more postoperative pulmonary complications (PPCs)
研究概览
简要总结
The purpose of this international multicenter, patient and outcome-assessor blinded randomized controlled trial is to determine whether the application of an individualized high Positive End Expiratory Pressure (PEEP) strategy with recruitment maneuvers, aiming at avoiding an increase in the driving pressure during intraoperative ventilation, protects against the development of postoperative pulmonary complications in patients undergoing minimally invasive abdominal surgery.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Proportion of participants developing one or more postoperative pulmonary complications (PPCs)
时间窗: The first 5 postoperative days
A composite of the following pulmonary complications: mild respiratory failure; severe respiratory failure; bronchospasm; suspected pulmonary infection; pulmonary infiltrate; aspiration pneumonitis; atelectasis; acute respiratory distress syndrome (ARDS); pleural effusion; cardiopulmonary edema; pneumothorax
次要结局
- Intraoperative complications(For the duration of general anesthesia, these outcomes are scored every hour up to a maximum of 18 hours)
- Intraoperative fluid strategy(During general anesthesia)
- Antibiotics use(The first 5 postoperative days)
- Length of stay(Postoperatively until the end of the 90 day follow-up period)
- Thoracic imaging(The first 5 postoperative days)
- Oxygen use(The first 5 postoperative days)
- Impaired wound healing(The first 5 postoperative days)
- Postoperative extrapulmonary complications(The first 5 postoperative days)
- Mortality(Postoperative day 5, day 30 and day 90)
研究者
Prof. Dr. Marcus J. Schultz
Professor of Intensive Care Medicine, Principal Investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)