Actively Recruiting
Driving Pressure During General Anesthesia for Minimally Invasive Abdominal Surgery (GENERATOR)
Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2025-01-30
1806
Participants Needed
1
Research Sites
194 weeks
Total Duration
On this page
Sponsors
A
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead Sponsor
O
Onze Lieve Vrouwe Gasthuis
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this international multicenter, patient and outcome-assessor blinded randomized controlled trial is to determine whether the application of an individualized high Positive End Expiratory Pressure (PEEP) strategy with recruitment maneuvers, aiming at avoiding an increase in the driving pressure during intraoperative ventilation, protects against the development of postoperative pulmonary complications in patients undergoing minimally invasive abdominal surgery.
CONDITIONS
Official Title
Driving Pressure During General Anesthesia for Minimally Invasive Abdominal Surgery (GENERATOR)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 18 years
- Scheduled for minimally invasive abdominal surgery
- At increased risk of postoperative pulmonary complications based on ARISCAT risk score (26 points or higher) or combination of age over 40 years, surgery longer than 2 hours, and planned intra-arterial blood pressure monitoring
- Signed written informed consent
You will not qualify if you...
- Planned open abdominal surgery
- Planned surgery in lateral or prone position
- Planned combined abdominal and intra-thoracic surgery
- Confirmed pregnancy
- Participation in another interventional trial during anesthesia
- Received invasive ventilation for more than 30 minutes in the last five days
- Previous lung surgery
- History of severe chronic obstructive pulmonary disease requiring home ventilation or oxygen therapy or frequent corticosteroid treatment
- History of acute respiratory distress syndrome
- Expected need for postoperative ventilation
- Expected hemodynamic instability or intractable shock
- Severe cardiac disease classified as New York Heart Association class III or IV, acute coronary syndrome, or persistent ventricular tachyarrhythmias
AI-Screening
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Trial Site Locations
Total: 1 location
1
Amsterdam University Medical Center
Amsterdam, Noordholland, Netherlands, 1105AZ
Actively Recruiting
Research Team
T
Tom Vermeulen, MD
CONTACT
G
Galina Dorland, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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