Status:
RECRUITING
Driving Pressure During General Anesthesia for Minimally Invasive Abdominal Surgery (GENERATOR)
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborating Sponsors:
Onze Lieve Vrouwe Gasthuis
HagaZiekenhuis
Conditions:
Postoperative Complications
Surgery
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief 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 Positive End Expirator...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- age \> 18 years; AND
- scheduled for minimally invasive abdominal surgery; AND
- at increased (i.e., intermediate or high) risk of PPCs according to the 'Assess Respiratory risk in Surgical Patients in Catalonia' (ARISCAT) risk score (≥ 26 points, see Appendix I); OR at increased risk of PPCs based on the combination of age \> 40 years, scheduled surgery lasting \> 2 hours and planned to receive an intra-arterial catheter for blood pressure monitoring during the surgery; AND
- signed written informed consent
- Exclusion criteria:
- planned for open abdominal surgery;
- planned for surgery in lateral or prone position;
- planned for combined abdominal and intra-thoracic surgery
- confirmed pregnancy;
- consent for another interventional trial during anesthesia;
- having received invasive ventilation \> 30 minutes within the last five days;
- any previous lung surgery;
- history of previous severe chronic obstructive pulmonary disease (COPD) with (noninvasive) ventilation or oxygen therapy at home or repeated systemic corticosteroid therapy for acute exacerbations of COPD;
- history of acute respiratory distress syndrome (ARDS);
- expected to require postoperative ventilation;
- expected hemodynamic instability or intractable shock;
- severe cardiac disease (New York Heart Association class III or IV, acute coronary syndrome or persistent ventricular tachyarrhythmia's).
Exclusion
Key Trial Info
Start Date :
December 11 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
1806 Patients enrolled
Trial Details
Trial ID
NCT06101511
Start Date
December 11 2023
End Date
September 1 2027
Last Update
January 30 2025
Active Locations (1)
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1
Amsterdam University Medical Center
Amsterdam, Noordholland, Netherlands, 1105AZ