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

  • STATUS
    Recruiting
  • End date
    Jul 8, 2024
  • participants needed
    440
  • sponsor
    Rennes University Hospital
Updated on 22 July 2021

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 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

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

Details
Condition Postoperative Pulmonary Complications
Treatment Control group, Intervention group_MRA
Clinical Study IdentifierNCT04408495
SponsorRennes University Hospital
Last Modified on22 July 2021

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note