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

Rennes University Hospital

Status: Active, not recruiting

Conditions: Postoperative Pulmonary Complications

Treatments: Procedure: Intervention group_MRA; Procedure: Control group

Study type: Interventional

Funder types: Other

Identifiers

NCT04408495

35RC18_8854_VACARM

Details and patient eligibility

About

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

Full description

In this randomized controlled trial, cardiac surgery patients at risk of postoperative pulmonary complications will be assigned to intraoperative ventilation with high PEEP and RM or intraoperative mechanical ventilation with low PEEP and without RM. The primary endpoint will be a composite endpoint including major postoperative complications within the first postoperative week and death within the 28 days after surgery

Enrollment: 440 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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440 participants in 2 patient groups

Intervention group_MRA

Experimental group

Description:

Recruitment maneuvers and high PEEP

Treatment:

Procedure: Intervention group_MRA

Control group

Active Comparator group

Description:

No recruitment maneuvers and low PEEP

Treatment:

Procedure: Control group