Comparing ventilation methods during heart surgery to reduce lung complications

Effect of IntraoperatiVe High Positive End-ExpirAtory Pressure (PEEP) With ReCruitment MAneuveRs vs Low PEEP on Major Postoperative Pulmonary Complications and Death After On-pump Cardiac Surgery in High-risk Patients: the VACARM Study

This study is testing whether using different breathing methods during heart surgery can help high-risk patients avoid lung problems and recover better afterwards.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 440 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Rennes University Hospital (Academic / other)
• Locations: 10 sites (Amiens and 9 other locations)
• Trial ID: NCT04408495 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of two different intraoperative mechanical ventilation strategies on patients undergoing cardiac surgery who are at high risk for postoperative pulmonary complications. Participants will be randomly assigned to receive either high positive end-expiratory pressure (PEEP) with recruitment maneuvers or low PEEP without recruitment maneuvers during surgery. The primary goal is to assess the incidence of major postoperative complications and mortality within 28 days following surgery. This study aims to clarify the optimal ventilation approach to improve patient outcomes after cardiac procedures.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 years old undergoing cardiac surgery with a pulmonary risk score of 2 or higher.

Not a fit: Patients with severe obesity, significant heart dysfunction, or those undergoing emergency or specific types of cardiac surgeries may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved postoperative recovery and reduced complications for high-risk cardiac surgery patients.

How similar studies have performed: Previous studies have shown varying results regarding ventilation strategies in cardiac surgery, indicating that this approach may provide new insights into optimizing patient care.

Eligibility criteria

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

Where this trial is running

Amiens and 9 other locations

• CHU Amiens-Picardie — Amiens, France (Recruiting)
• CHRU Brest — Brest, France (Recruiting)
• CHU de Dijon — Dijon, France (Recruiting)
• CHU de Nancy — Nancy, France (Recruiting)
• CHU Poitiers — Poitiers, France (Not_yet_recruiting)
• CHU Rennes — Rennes, France (Recruiting)
• CHU de Rouen — Rouen, France (Recruiting)
• CHU Nantes — Saint-Herblain, France (Recruiting)
• CHU de Toulouse — Toulouse, France (Recruiting)
• CHRU Tours — Tours, France (Recruiting)

Study contacts

• Principal investigator: Nathalie DEMAURE — CHU Rennes
• Study coordinator: Nathalie DEMAURE

Conditions Postoperative Pulmonary Complications; recruitment maneuvers; Postoperative pulmonary complications; Peep; Cardiac surgery; Mortality