Driving Pressure During General Anesthesia for Minimally Invasive Abdominal Surgery (GENERATOR) (NCT06101511) | Clinical Trial Compass
RecruitingNot Applicable
Driving Pressure During General Anesthesia for Minimally Invasive Abdominal Surgery (GENERATOR)
Netherlands1,806 participantsStarted 2023-12-11
Plain-language summary
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.
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
. age \> 18 years; AND
. scheduled for minimally invasive abdominal surgery; AND
. at increased (i.e., intermediate or high) risk of PPCs according to the 'Assess Respiratory risk in Surgical Patients in Catalonia' (ARISCAT) risk score (≥ 26 points, see Appendix I); OR at increased risk of PPCs based on the combination of age \> 40 years, scheduled surgery lasting \> 2 hours and planned to receive an intra-arterial catheter for blood pressure monitoring during the surgery; AND
. signed written informed consent
Exclusion criteria
. planned for open abdominal surgery;
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 IDNCT06101511
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
. planned for surgery in lateral or prone position;
. planned for combined abdominal and intra-thoracic surgery
. confirmed pregnancy;
. consent for another interventional trial during anesthesia;
. having received invasive ventilation \> 30 minutes within the last five days;
. any previous lung surgery;
. history of previous severe chronic obstructive pulmonary disease (COPD) with (noninvasive) ventilation or oxygen therapy at home or repeated systemic corticosteroid therapy for acute exacerbations of COPD;