Driving Pressure During General Anesthesia for Open Abdominal Surgery (DESIGNATION)

  • STATUS
    Recruiting
  • End date
    Mar 11, 2023
  • participants needed
    1468
  • sponsor
    Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Updated on 11 March 2022

Summary

The purpose of this international multicenter, patient and outcome-assessor blinded randomized controlled trial is to determine whether the application of an individualized high PEEP strategy, aiming at avoiding an increase in the driving pressure during intraoperative ventilation, protects against the development of postoperative pulmonary complications.

Details
Condition Postoperative Respiratory Complication
Treatment Individualized high PEEP strategy
Clinical Study IdentifierNCT03884543
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Last Modified on11 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Scheduled for open abdominal surgery
High or intermediate risk for postoperative pulmonary complications according to ARISCAT score [J.Canet et al, Anesthesiology 2010;113]
General anesthesia

Exclusion Criteria

Laparoscopic surgery
Surgery in prone or lateral position
Combined procedure with open abdominal and intrathoracic surgery
Body mass index > 40 kg/m2
Reported pregnancy
Mechanical ventilation > than 30 minutes (e.g., in cases of general anesthesia because of surgery) within last 30 days
Any major previous lung surgery
History of previous severe chronic obstructive pulmonary disease (COPD) GOLD III or IV, or with (noninvasive) ventilation and/or oxygen therapy at home
(previous) acute respiratory distress syndrome (ARDS)
Expected to require postoperative mechanical ventilation
Persistent hemodynamic instability or intractable shock
Severe cardiac disease (New York Heart Association class III or IV, or acute coronary syndrome, or persistent ventricular tachyarrhythmia's)
Consented for another interventional study during anesthesia or refusal to participate in the study
Clear my responses

How to participate?

Step 1 Connect with a study center
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

Primary Contact

site

0/250

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