Driving Pressure During General Anesthesia for Minimally Invasive Abdominal Surgery (GENERATOR)
NCT ID: NCT06101511
Last Updated: 2025-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1806 participants
INTERVENTIONAL
2023-12-11
2027-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Individualized high PEEP strategy with recruitment maneuvers
The intervention is intraoperative ventilation using the available ventilator with individualized high positive end-expiratory pressure (PEEP) titrated to the lowest driving pressure (ΔP) with recruitment maneuvers (RMs). After abdominal insufflation, patients randomized to the individualized high PEEP with RMs group will receive a RM followed by a 'decremental PEEP trial'. This is followed by a second RM after which PEEP is set at the level indicated by the decremental PEEP trial.
Intraoperative ventilation with individualized high PEEP titrated to the lowest ΔP with RMs
The intervention is intraoperative ventilation using the available ventilator with individualized high PEEP titrated to the lowest ΔP with RMs. After abdominal insufflation, patients randomized to the individualized high PEEP with RMs group will receive a RM followed by a 'decremental PEEP trial'. This is followed by a second RM after which PEEP is set at the level indicated by the decremental PEEP trial
Standard low PEEP strategy without recruitment maneuvers
Patients randomized to the standard low PEEP group will receive 5 cm H2O PEEP for the complete duration of general anesthesia. They will neither receive one of the planned RMs nor a decremental PEEP trial.
No interventions assigned to this group
Interventions
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Intraoperative ventilation with individualized high PEEP titrated to the lowest ΔP with RMs
The intervention is intraoperative ventilation using the available ventilator with individualized high PEEP titrated to the lowest ΔP with RMs. After abdominal insufflation, patients randomized to the individualized high PEEP with RMs group will receive a RM followed by a 'decremental PEEP trial'. This is followed by a second RM after which PEEP is set at the level indicated by the decremental PEEP trial
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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).
18 Years
100 Years
ALL
No
Sponsors
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Onze Lieve Vrouwe Gasthuis
OTHER
HagaZiekenhuis
OTHER
Dijklander Ziekenhuis
OTHER
The Netherlands Cancer Institute
OTHER
Isala
OTHER
Maasstad Hospital
OTHER
Medisch Spectrum Twente
OTHER
University Medical Center Groningen
OTHER
Leiden University Medical Center
OTHER
Hospital Universitario La Fe
OTHER
Ospedale Policlinico San Martino
OTHER
University Hospital Carl Gustav Carus
OTHER
Medical University Innsbruck
OTHER
Spaarne Gasthuis
OTHER
Zaans Medical Center
OTHER
Alrijne Hospital
OTHER
Albert Schweitzer Hospital
OTHER
Maastricht University Medical Center
OTHER
Noordwest Ziekenhuisgroep
OTHER
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Responsible Party
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Prof. Dr. Marcus J. Schultz
Professor of Intensive Care Medicine, Principal Investigator
Principal Investigators
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Marcus Schultz, Professor
Role: STUDY_CHAIR
Amsterdam University Medical Center, location AMC
Markus Hollmann, Professor
Role: PRINCIPAL_INVESTIGATOR
Amsterdam University Medical Center, location AMC
David van Meenen, PhD
Role: PRINCIPAL_INVESTIGATOR
Amsterdam University Medical Center, location AMC
Sabrine Hemmes, PhD
Role: PRINCIPAL_INVESTIGATOR
Amsterdam University Medical Center, location AMC
Locations
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Amsterdam University Medical Center
Amsterdam, Noordholland, Netherlands
Countries
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Central Contacts
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Facility Contacts
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References
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GENERATOR-investigators. Driving pressure during general anesthesia for minimally invasive abdominal surgery (GENERATOR)-study protocol of a randomized clinical trial. Trials. 2024 Oct 26;25(1):719. doi: 10.1186/s13063-024-08479-x.
Other Identifiers
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NL82971.018.23
Identifier Type: -
Identifier Source: org_study_id
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