CompletedNot Applicable

Intraoperative Protective Mechanical Ventilation in Patients Requiring Emergency Abdominal Surgery

France707 participantsStarted 2021-02-18

Plain-language summary

The aim of this study is to compare the effects of a strategy aimed at increasing alveolar recruitment (high PEEP levels adjusted according to driving pressure and recruitment maneuvers) with that of a strategy aimed at minimizing alveolar distension (low PEEP level without recruitment maneuver) on postoperative respiratory failure and mortality in patients receiving low VT ventilation during emergency abdominal surgery.

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) * Patients requiring emergency (defined by the need to proceed to surgery within a few hours after diagnosis) * Laparoscopic or non-laparoscopic abdominal surgery under general anesthesia and with an expected duration of at least two hours Exclusion Criteria: * Patients already receiving mechanical ventilation for more than 12 hours before enrollment * Intracranial hypertension * Chronic respiratory disease requiring oxygen therapy or mechanical ventilation at home * Undrained pneumothorax or subcutaneous emphysema * Patients for which death is deemed imminent and inevitable or patients with an underlying disease process with a life expectancy of less than 3 month * Body mass index (BMI) \>40 kg/m2 * Pregnant or breastfeeding women * Patients already enrolled in the IMPROVE-2 trial * Participation in a confounding trial with mortality or PRF as the main endpoint * Patient's or relative's refusal to participate * Guardianship or trusteeship patient * No affiliation to the Social Security system

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

Postoperative respiratory failure

Timeframe: Hospital discharge - Up to day 30

Trial details

NCT IDNCT03987789

SponsorUniversity Hospital, Clermont-Ferrand

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-07-29

View on ClinicalTrials.gov More Emergency Abdominal Surgery trials