Intraoperative Mechanical Ventilation and Postoperative Pulmonary Complications After On-pump Cardiac Surgery in High-risk Patients
Launched by RENNES UNIVERSITY HOSPITAL · May 25, 2020
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the effects of two different ways of using mechanical ventilation (a machine that helps patients breathe) during heart surgery. The goal is to find out which method leads to fewer breathing problems after surgery for patients who are at high risk for these complications. While it's common to use low tidal volumes (the amount of air delivered to the lungs), there is still debate about the best settings for pressure in the lungs and whether certain techniques to open the airways should be used.
To participate in this trial, patients need to be over 18 years old and scheduled for heart surgery, such as bypass surgery or valve replacement. They should have a higher risk for lung issues, as indicated by a specific scoring system. However, patients with certain conditions, like obesity or severe heart issues, may not be eligible. Those who join the study can expect to receive one of the two ventilation methods during their surgery, and their recovery will be monitored to see how well they do afterward. It's important for potential participants to know that they will need to give permission to be part of this study and that their safety and well-being will be a top priority throughout the process.
Gender
ALL
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
About Rennes University Hospital
Rennes University Hospital, a leading academic medical center in France, is dedicated to advancing healthcare through innovative clinical research and trials. With a strong emphasis on patient-centered care, the hospital integrates cutting-edge scientific research with clinical practice, fostering collaboration among multidisciplinary teams. Its commitment to excellence is reflected in its robust infrastructure and expertise in various medical fields, enabling the development and evaluation of novel therapies and treatment protocols. By participating in clinical trials, Rennes University Hospital aims to enhance patient outcomes and contribute to the global body of medical knowledge.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Poitiers, , France
Rennes, , France
Toulouse, , France
Toulouse, , France
Angers, , France
Rouen, , France
Nancy, , France
Dijon, , France
Tours, , France
Dijon, , France
Brest, , France
Amiens, , France
Nancy, , France
Saint Herblain, , France
Patients applied
Trial Officials
Nathalie DEMAURE
Principal Investigator
CHU Rennes
Nicolas NESSELER, MD
Principal Investigator
CHU Rennes
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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