Clinical trial NCT06101511: Driving Pressure During General Anesthesia for Minimally Invasive Abdominal Surgery (GENERATOR)
Official title: Driving Pressure During General Anesthesia for Minimally Invasive Abdominal Surgery (GENERATOR) - a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Complications
Surgery
Keywords: Minimally invasive abdominal surgery
Mechanical ventilation
Positive end-expiratory pressure
Driving pressure
Postoperative pulmonary complications
Recruitment maneuver
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Onze Lieve Vrouwe Gasthuis
name: HagaZiekenhuis
name: Dijklander Ziekenhuis
name: The Netherlands Cancer Institute
name: Isala
name: Maasstad Hospital
name: Medisch Spectrum Twente
name: University Medical Center Groningen
name: Leiden University Medical Center
name: Hospital Universitario La Fe
name: Ospedale Policlinico San Martino
name: University Hospital Carl Gustav Carus
name: Medical University Innsbruck
name: Spaarne Gasthuis
name: Zaans Medical Center
name: Alrijne Hospital
name: Albert Schweitzer Hospital
name: Maastricht University Medical Center
name: Noordwest Ziekenhuisgroep
First posted: 2023-10-26
Enrollment: 1806
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility criteria: Inclusion criteria:

1. age \> 18 years; AND
2. scheduled for minimally invasive abdominal surgery; AND
3. 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
4. signed written informed consent

Exclusion criteria:

1. planned for open abdominal surgery;
2. planned for surgery in lateral or prone position;
3. planned for combined abdominal and intra-thoracic surgery
4. confirmed pregnancy;
5. consent for another interventional trial during anesthesia;
6. having received invasive ventilation \> 30 minutes within the last five days;
7. any previous lung surgery;
8. 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;
9. history of acute respiratory distress syndrome (ARDS);
10. expected to require postoperative ventilation;
11. expected hemodynamic instability or intractable shock;
12. severe cardiac disease (New York Heart Association class III or IV, acute coronary syndrome or persistent ventricular tachyarrhythmia's).

Primary outcomes:
measure: Proportion of participants developing one or more postoperative pulmonary complications (PPCs)
timeFrame: The first 5 postoperative days
Secondary outcomes:
measure: Intraoperative complications
timeFrame: For the duration of general anesthesia, these outcomes are scored every hour up to a maximum of 18 hours
measure: Intraoperative fluid strategy
timeFrame: During general anesthesia
measure: Impaired wound healing
timeFrame: The first 5 postoperative days
measure: Postoperative extrapulmonary complications
timeFrame: The first 5 postoperative days
measure: Mortality
timeFrame: Postoperative day 5, day 30 and day 90
measure: Length of stay
timeFrame: Postoperatively until the end of the 90 day follow-up period
measure: Oxygen use
timeFrame: The first 5 postoperative days
measure: Antibiotics use
timeFrame: The first 5 postoperative days
measure: Thoracic imaging
timeFrame: The first 5 postoperative days
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam University Medical Center
state: Noordholland
Study officials:
affiliation: Amsterdam University Medical Center, location AMC
name: Marcus Schultz, Professor
role: STUDY_CHAIR
affiliation: Amsterdam University Medical Center, location AMC
name: Markus Hollmann, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Amsterdam University Medical Center, location AMC
name: David van Meenen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Amsterdam University Medical Center, location AMC
name: Sabrine Hemmes, PhD
role: PRINCIPAL_INVESTIGATOR
References: