Mechanical Power for Ventilatory Settings in Operating Room (NCT07620132) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Mechanical Power for Ventilatory Settings in Operating Room
490 participantsStarted 2026-06-01
Plain-language summary
Postoperative respiratory failure (PRF) is a dreaded complication that imposes a significant burden through unplanned admission to the ICU, post discharge disability and mortality. Despite widespread implementation of intraoperative lung-protective ventilation strategies over the past decade, results remain inconsistent. Interventions targeting individual parameters like tidal volume or positive end-expiratory pressure (PEEP) have shown equivocal results. The use of high PEEP and recruitment maneuvers raises safety concerns by possible negative hemodynamic effects. Recent studies suggest that individualizing ventilation strategies based on mechanical power-a composite parameter integrating tidal volume, plateau pressure, PEEP, and ventilator frequency-may better predict and help prevent PRF, independently of patients' baseline respiratory system compliance. These studies identified this parameter as interventional targets to reduce lung injury during mechanical ventilation. However, no multicenter randomized controlled trial has been performed in the field of ventilatory settings titration during invasive mechanical ventilation in operating room.
The investigators hypothesize that a ventilation strategy aimed at decreasing mechanical power will reduce the incidence of PRF and mortality in patients undergoing abdominal surgery, compared with a standard strategy using fixed tidal volume and PEEP
Who can participate
Age range
18 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:
* Adult (≥ 18 years)
* Laparoscopic or non-laparoscopic abdominal surgery
* With an expected duration of at least 2 hours
Exclusion Criteria:
* Patients already receiving mechanical ventilation \> 12 hours before surgery;
* Chronic respiratory disease requiring oxygen therapy or mechanical ventilation at home;
* Undrained pneumothorax or subcutaneous emphysema;
* Intracranial hypertension;
* Patients for which death is deemed imminent and inevitable or patients with an underlying disease process with a life expectancy of less than 3 months;
* Patients already enrolled in the IMPROVE III trial;
* Pregnancy in progress or planned during the study period or breastfeeding women (Art. L1121-5 of the French Public Health Code);
* Patients protected by law (Art. L1121-6 to L1121-8 of the French Public Health Code): Individuals deprived of their liberty by judicial or administrative decision, vulnerable persons, minors, adults under guardianship or curatorship;
* Patients not covered by a French social security scheme and not benefiting from such a scheme;
* Absence of free and informed oral consent from the patient before inclusion (except in emergency situation where the patient is unable to provide consent), or absence of written informed consent from his/her proxy if present in an emergency situation (except in life-threatening emergency, where inclusion without consent from the patient or his/her proxy is permitted), in which case consent will be obtained …
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
Composite of postoperative respiratory failure
Timeframe: Up to 12 hours after surgery
2
Composite of postoperative respiratory failure
Timeframe: Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
3
Composite of postoperative respiratory failure
Timeframe: Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
4
All-cause mortality
Timeframe: Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30