Status:
ACTIVE_NOT_RECRUITING
Intraoperative Mechanical Ventilation and Postoperative Pulmonary Complications After On-pump Cardiac Surgery in High-risk Patients
Lead Sponsor:
Rennes University Hospital
Conditions:
Postoperative Pulmonary Complications
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 optim...
Detailed 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 me...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
440 Patients enrolled
Trial Details
Trial ID
NCT04408495
Start Date
July 8 2021
End Date
September 30 2026
Last Update
September 17 2025
Active Locations (10)
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1
CHU Amiens-Picardie
Amiens, France
2
CHRU Brest
Brest, France
3
CHU de Dijon
Dijon, France
4
CHU de Nancy
Nancy, France