CompletedNot Applicable

Intraoperative Mechanical Ventilation and Postoperative Pulmonary Complications After On-pump Cardiac Surgery in High-risk Patients

France441 participantsStarted 2021-07-08

Plain-language summary

Controversies remain concerning the best intraoperative mechanical ventilation regimen for major cardiac surgery. While the use of intra operative low tidal volumes is now standard practice, the optimal level of positive end-expiratory pressure (PEEP) and the use of recruitment maneuvers (RM) remain controversial. The aim of this study is to compare two regimens of intraoperative mechanical ventilation on postoperative outcomes in cardiac surgery patients at risk of postoperative pulmonary complications

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients older than 18 years-old, * Evaluated before cardiopulmonary bypass for any cardiac surgical procedure (e.g. coronary artery bypass grafting, valve, aorta, or combined procedures), * With a pulmonary risk score ≥ 2 * Who gave written informed consent * affiliated to a social security system Exclusion Criteria: * BMI \> 40kg/m2 ; * Left Ventricular Ejection Fraction \< 35% ; * Preoperative shock ; * Aortic surgery with planned circulatory arrest ; * Minimally invasive cardiac surgery ; * Emergency surgery with patient unable to give written informed consent * Heart transplantation * Mechanical circulatory support surgery * Pregnant or lactating women * Adults legally protected (under judicial protection, guardianship, or supervision), persons deprived of their liberty

What they're measuring

Rate of major pulmonary complications and death

Timeframe: 28 days after surgery

Trial details

NCT IDNCT04408495

SponsorRennes University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-16