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.
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of participants developing one or more postoperative pulmonary complications (PPCs)
Timeframe: The first 5 postoperative days
Trial details
NCT IDNCT03884543
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)