Informations générales (source: ClinicalTrials.gov)

NCT04408495 En recrutement
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 (VACARM)
Interventional
N/A
Rennes University Hospital (Voir sur ClinicalTrials)
juillet 2021
juillet 2026
04 avril 2025
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
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Etablissements

Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CHRU Brest - Brest - France Jean-Ferréol OILLEAU, MD En recrutement Contact (sur clinicalTrials)
CHRU Tours - Tours - France Fabien ESPITALIER, MD En recrutement Contact (sur clinicalTrials)
CHU Nantes - Saint-Herblain - France Bertrand ROZEC, MD En recrutement Contact (sur clinicalTrials)
CHU Poitiers - Poitiers - France Thomas KERFONE, MD Recrutement non commencé Contact (sur clinicalTrials)
CHU Rennes - Rennes - France Nathalie DEMAURE En recrutement Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CHU Amiens-Picardie - Amiens - France Osama ABOU ARAB, MD En recrutement Contact (sur clinicalTrials)
CHU de Dijon - Dijon - France Pierre-Grégoire GUINOT, MD En recrutement Contact (sur clinicalTrials)
CHU de Nancy - Nancy - France Philippe GUERCI, MD En recrutement Contact (sur clinicalTrials)
CHU de Rouen - Rouen - France Emmanuel BESNIER, MD En recrutement Contact (sur clinicalTrials)
CHU de Toulouse - Toulouse - France François LABASTE, MD En recrutement Contact (sur clinicalTrials)

Critères

Tous
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



- 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