Driving Pressure During General Anesthesia for Open Abdominal Surgery
NCT ID: NCT03884543
Last Updated: 2025-11-19
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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COMPLETED
NA
1468 participants
INTERVENTIONAL
2019-04-23
2025-06-01
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
Recruitment maneuver (performed after induction of anesthesia, after any disconnection from the mechanical ventilator, and before extubation) followed by the decremental PEEP trial to determine the highest level of PEEP resulting in the lowest driving pressure. This is again followed by a recruitment maneuver, after which PEEP is set at the level indicated by the decremental PEEP trial.
Individualized high PEEP strategy
Patients are randomized and intra-operatively ventilated with an individualized high PEEP strategy (Highest PEEP with the lowest driving pressure with recruitment maneuvers)
Standard low PEEP strategy
PEEP at maximum 5cm H2O. No recruitment maneuvers. Patients are randomized and intraoperatively ventilated with conventional strategy. (PEEP at maximum 5cm H2O without recruitment maneuvers)
No interventions assigned to this group
Interventions
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Individualized high PEEP strategy
Patients are randomized and intra-operatively ventilated with an individualized high PEEP strategy (Highest PEEP with the lowest driving pressure with recruitment maneuvers)
Eligibility Criteria
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Inclusion Criteria
* High or intermediate risk for postoperative pulmonary complications according to ARISCAT score \[J.Canet et al, Anesthesiology 2010;113\]
* General anesthesia
Exclusion Criteria
* 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
18 Years
100 Years
ALL
No
Sponsors
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Amsterdam UMC, location VUmc
OTHER
Noord West Ziekenhuizen location Alkmaar
UNKNOWN
University Medical Center Groningen
OTHER
Radboud University Medical Center
OTHER
HagaZiekenhuis
OTHER
Rijnstate Hospital
OTHER
Medical Center Haaglanden
OTHER
Bernhoven Hospital
OTHER
Onze Lieve Vrouwe Gasthuis
OTHER
Albert Schweitzer Hospital
OTHER
Frisius Medisch Centrum
OTHER
Leiden University Medical Center
OTHER
Maastricht University Medical Center
OTHER
Martini Hospital Groningen
OTHER
Erasmus Medical Center
OTHER
Spaarne Gasthuis
OTHER
University Hospital Carl Gustav Carus
OTHER
Bermanntrost BG Klinikum Halle
UNKNOWN
Heinrich-Heine University, Duesseldorf
OTHER
Ospedale Policlinico San Martino
OTHER
Jeroen Bosch Ziekenhuis
OTHER
Meander Medical Center
OTHER
Isala
OTHER
Alrijne Hospital
OTHER
Antoni van Leeuwenhoek Ziekenhuis
UNKNOWN
Medisch Spectrum Twente
OTHER
Campus Bio-Medico University
OTHER
Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
NETWORK
University of Roma La Sapienza
OTHER
University of Campania Luigi Vanvitelli
OTHER
Hospital Universitario La Fe
OTHER
Medical University Innsbruck
OTHER
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Responsible Party
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Prof. Dr. Marcus J. Schultz
Principal Investigator
Principal Investigators
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Marcus J. Schultz, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Intensive Care
Markus W. Hollmann, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Anesthesiology
Locations
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University hospital Carl Gustav Carus
Dresden, , Germany
Heinrich-Heine University Hospital Dusseldorf
Düsseldorf, , Germany
Bermanntrost BG Klinikum Halle
Halle, , Germany
Ospedale Policlinico San Martino
Genoa, , Italy
University hospital Napoli
Napoli, , Italy
Noordwest ziekenhuizengroep Alkmaar
Alkmaar, , Netherlands
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Amsterdam, , Netherlands
Amsterdam UMC location VUmc
Amsterdam, , Netherlands
Onze Lieve Vrouwen Gasthuis
Amsterdam, , Netherlands
Rijnstate Hospital
Arnhem, , Netherlands
Albert Schweitzer Ziekenhuis
Dordrecht, , Netherlands
Martini Hospital
Groningen, , Netherlands
UMC Groningen
Groningen, , Netherlands
Spaarne Gasthuis Hospital
Haarlem, , Netherlands
Medical Center Leeuwarden
Leeuwarden, , Netherlands
Leiden UMC
Leiden, , Netherlands
Maastricht UMC
Maastricht, , Netherlands
Radboud UMC
Nijmegen, , Netherlands
Erasmus Medisch Centrum
Rotterdam, , Netherlands
Haaglanden Medisch Centrum
The Hague, , Netherlands
HAGA
The Hague, , Netherlands
Bernhoven Hospital
Uden, , Netherlands
Countries
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References
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Mehta RL, Kellum JA, Shah SV, Molitoris BA, Ronco C, Warnock DG, Levin A; Acute Kidney Injury Network. Acute Kidney Injury Network: report of an initiative to improve outcomes in acute kidney injury. Crit Care. 2007;11(2):R31. doi: 10.1186/cc5713.
DESIGNATION-investigators. Driving Pressure During General Anesthesia for Open Abdominal Surgery (DESIGNATION): study protocol of a randomized clinical trial. Trials. 2020 Feb 18;21(1):198. doi: 10.1186/s13063-020-4075-z.
Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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DESIGNATION
Identifier Type: -
Identifier Source: org_study_id
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