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| Name | Class |
|---|---|
| Amsterdam UMC, location VUmc | OTHER |
| Noord West Ziekenhuizen location Alkmaar | UNKNOWN |
| University Medical Center Groningen | OTHER |
| Radboud University Medical Center |
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The purpose of this international multicenter, patient and outcome-assessor blinded randomized controlled trial is to determine whether the application of an individualized high PEEP strategy, aiming at avoiding an increase in the driving pressure during intraoperative ventilation, protects against the development of postoperative pulmonary complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individualized high PEEP strategy | Experimental | 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. |
|
| Standard low PEEP strategy | No Intervention | 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) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Individualized high PEEP strategy | Procedure | Patients are randomized and intra-operatively ventilated with an individualized high PEEP strategy (Highest PEEP with the lowest driving pressure with recruitment maneuvers) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants developing one or more postoperative pulmonary complications (PPCs) | Severe respiratory failure; ARDS; Suspected pulmonary infection; Pulmonary infiltrate ; Pleural effusion; Atelectasis; Pneumothorax; Bronchospasm; Aspiration pneumonitis; Cardiopulmonary edema | The first 5 postoperative days |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of mild respiratory failures | Defined as a PaO2 < 60 mmHg (or < 7.9 kPa) or SpO2 < 90% in room air, but responding to supplemental oxygen (excluding hypoventilation) | The first 5 postoperative days |
| Proportion of participants developing one or more post-operative extra-pulmonary complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marcus J. Schultz, MD PhD | Department of Intensive Care | Principal Investigator |
| Markus W. Hollmann, MD PhD | Department of Anesthesiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University hospital Carl Gustav Carus | Dresden | Germany | ||||
| Heinrich-Heine University Hospital Dusseldorf |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17331245 | Result | 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. | |
| 41334859 | Derived | Writing and Steering Committees for the DESIGNATION-Investigators; Dorland G, Gama de Abreu M, Hemmes SNT, Hol L, Hollmann MW, van Meenen DMP, Nijbroek SGLH, Schultz MJ, Serpa Neto A, Vermeulen TD. Intraoperative Driving Pressure-Guided High PEEP vs Standard Low PEEP for Postoperative Pulmonary Complications. JAMA. 2026 Feb 24;335(8):693-702. doi: 10.1001/jama.2025.23373. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 12, 2025 | Jan 13, 2025 |
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| 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 |
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Including sepsis (according to the SEPSIS-3 definition), septic shock (defined as sepsis with persisting hypotension requiring vasopressors to maintain MAP ≥ 65mmHg and having a serum lactate level >2 mmol/L despite adequate volume resuscitation), extra-pulmonary infection (including wound infection and any other infection), anastomic leak and acute renal failure (as defined by AKIN [Mehta RL., et al., Acute Kidney Injury Network: report of an initiative to improve outcomes in acute kidney injury. Crit Care, 2007]) |
| The first 5 postoperative days |
| Rate of intra-operative complications | For the length of the anesthesia, which will be estimated 2 to 5 hours. |
| The total amount and type of intraoperative fluid administration | Type of fluids: colloids, crystalloids or blood products | For the length of the anesthesia, which will be estimated 2 to 5 hours |
| Rate of all-cause mortality and in-hospital mortality | Postoperative day 5, day 30 and day 90 |
| Length of hospital stay | From the day of surgery until the day of discharge, up to day 90 |
| Number of participants with an unscheduled Intensive Care Unit (ICU) (re-) admission and length of stay in Intensive care unit | From the day of surgery until the day of discharged, up to day 90 |
| Assessment of postoperative wound healing | Visual inspection of the following: impairment of wound healing and/or wound infection; | The first 5 postoperative days |
| Düsseldorf |
| Germany |
| Bermanntrost BG Klinikum Halle | Halle | Germany |
| Ospedale Policlinico San Martino | Genoa | Italy |
| University hospital Napoli | Naples | 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 |
| 32070400 | Derived | 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. |
| SAP_001.pdf |