NCT03884543已完成不适用
Driving Pressure During General Anesthesia for Open Abdominal Surgery (DESIGNATION) - a Randomized Clinical Trial
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)36 个研究点 分布在 3 个国家目标入组 1,468 人开始时间: 2019年4月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,468
- 试验地点
- 36
- 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 PEEP strategy, aiming at avoiding an increase in the driving pressure during intraoperative ventilation, protects against the development of postoperative pulmonary complications.
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
- •Scheduled for open abdominal surgery
- •High or intermediate risk for postoperative pulmonary complications according to ARISCAT score [J.Canet et al, Anesthesiology 2010;113]
- •General anesthesia
排除标准
- •Laparoscopic surgery
- •Surgery in prone or lateral position
- •Combined procedure with open abdominal and intrathoracic surgery
- •Body mass index > 40 kg/m2;
- •Reported pregnancy;
- •Mechanical ventilation > than 30 minutes (e.g., in cases of general anesthesia because of surgery) within last 30 days;
- •Any major previous lung surgery;
- •History of previous severe chronic obstructive pulmonary disease (COPD) GOLD III or IV, or with (noninvasive) ventilation and/or oxygen therapy at home;
- •(previous) acute respiratory distress syndrome (ARDS);
- •Expected to require postoperative mechanical ventilation;
- •Persistent hemodynamic instability or intractable shock;
- •Severe cardiac disease (New York Heart Association class III or IV, or acute coronary syndrome, or persistent ventricular tachyarrhythmia's);
- •Consented for another interventional study during anesthesia or refusal to participate in the study
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
Severe respiratory failure; ARDS; Suspected pulmonary infection; Pulmonary infiltrate ; Pleural effusion; Atelectasis; Pneumothorax; Bronchospasm; Aspiration pneumonitis; Cardiopulmonary edema
次要结局
- Rate of mild respiratory failures(The first 5 postoperative days)
- Number of participants with an unscheduled Intensive Care Unit (ICU) (re-) admission and length of stay in Intensive care unit(From the day of surgery until the day of discharged, up to day 90)
- Assessment of postoperative wound healing(The first 5 postoperative days)
- Length of hospital stay(From the day of surgery until the day of discharge, up to day 90)
- Rate of intra-operative complications(For the length of the anesthesia, which will be estimated 2 to 5 hours.)
- The total amount and type of intraoperative fluid administration(For the length of the anesthesia, which will be estimated 2 to 5 hours)
- Proportion of participants developing one or more post-operative extra-pulmonary complications(The first 5 postoperative days)
- Rate of all-cause mortality and in-hospital mortality(Postoperative day 5, day 30 and day 90)
研究者
Prof. Dr. Marcus J. Schultz
Principal Investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
研究点 (36)
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