ClinConnect ClinConnect Logo
Search / Trial NCT04408495

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

Recruitment Maneuvers Postoperative Pulmonary Complications Peep Cardiac Surgery Mortality

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.

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

0 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

Similar Trials