- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03884543
Driving Pressure During General Anesthesia for Open Abdominal Surgery (DESIGNATION)
January 12, 2024 updated by: Prof. Dr. Marcus J. Schultz, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Driving Pressure During General Anesthesia for Open Abdominal Surgery (DESIGNATION) - a Randomized Clinical Trial
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
1468
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sunny Nijbroek, MD
- Phone Number: +3120-56 62533
- Email: s.g.nijbroek@amc.nl
Study Contact Backup
- Name: Liselotte Hol, MD
- Phone Number: +3120-56 62533
- Email: l.hol@amc.nl
Study Locations
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Dresden, Germany
- Recruiting
- University Hospital Carl Gustav Carus
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Principal Investigator:
- Marcelo Gama de Abreu
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Contact:
- Marcelo Gama de Abreu
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Dusseldorf, Germany
- Recruiting
- Heinrich-Heine University Hospital Dusseldorf
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Contact:
- Ragnar Huhn
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Principal Investigator:
- Ragnar Ruhn
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Halle, Germany
- Recruiting
- Bermanntrost BG Klinikum Halle
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Contact:
- Herman Wrigge
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Principal Investigator:
- Herman Wrigge
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Genua, Italy
- Recruiting
- Ospedale Policlinico San Martino
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Contact:
- Denise Battaglini
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Principal Investigator:
- Paolo Pelosi
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Napoli, Italy
- Recruiting
- University hospital Napoli
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Contact:
- Pasquale Sansone
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Principal Investigator:
- Caterina Aurilio
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Alkmaar, Netherlands
- Recruiting
- Noordwest ziekenhuizengroep Alkmaar
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Contact:
- Gitara Edward-Rutten
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Principal Investigator:
- Johannes Zwijssen
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Amsterdam, Netherlands
- Recruiting
- Onze Lieve Vrouwen Gasthuis
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Contact:
- Bram Thiel
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Principal Investigator:
- Marc Godfried
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Amsterdam, Netherlands
- Recruiting
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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Principal Investigator:
- Marcus J Schultz, MD, PHD
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Contact:
- Sunny Nijbroek, MD
- Email: s.g.nijbroek@amc.uva.nl
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Contact:
- Liselotte Hol, MD
- Email: l.hol@amc.uva.nl
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Amsterdam, Netherlands
- Recruiting
- Amsterdam UMC Location VUMC
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Contact:
- Carolina Bulte
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Principal Investigator:
- Carolina Bulte
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Arnhem, Netherlands
- Recruiting
- Rijnstate Hospital
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Contact:
- Jose Geurts
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Principal Investigator:
- Myra Rynia
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Den Haag, Netherlands
- Recruiting
- Haaglanden Medisch Centrum
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Contact:
- Bernard Houweling
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Principal Investigator:
- Bas In 't Veld
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Den Haag, Netherlands
- Recruiting
- HAGA
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Contact:
- Mandana Rad
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Principal Investigator:
- Tim van der Zwan
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Dordrecht, Netherlands
- Recruiting
- Albert Schweitzer Ziekenhuis
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Contact:
- Gerda Kuijper
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Principal Investigator:
- André Stamkot
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Principal Investigator:
- Minke Kortekaas
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Groningen, Netherlands
- Recruiting
- UMC Groningen
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Contact:
- Miriam Zeillemaker
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Principal Investigator:
- Struys
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Groningen, Netherlands
- Not yet recruiting
- Martini Hospital
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Contact:
- Hans de Boer
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Principal Investigator:
- Hans de Boer
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Haarlem, Netherlands
- Not yet recruiting
- Spaarne Gasthuis Hospital
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Contact:
- Annemieke Boom
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Principal Investigator:
- Annemieke Boom
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Leeuwarden, Netherlands
- Not yet recruiting
- Medical Center Leeuwarden
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Contact:
- Tammo Brouwer
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Principal Investigator:
- Tammo Brouwer
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Leiden, Netherlands
- Recruiting
- Leiden UMC
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Contact:
- Hendrik Helmerhorst
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Contact:
- Ronald Akkerman
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Principal Investigator:
- Leon Aarts
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Maastricht, Netherlands
- Recruiting
- Maastricht UMC
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Contact:
- Dianne de Korte- de Boer
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Principal Investigator:
- Hans Ubben
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Nijmegen, Netherlands
- Recruiting
- Radboud UMC
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Contact:
- Jan Hofland
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Principal Investigator:
- Jan Hofland
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Rotterdam, Netherlands
- Recruiting
- Erasmus Medisch Centrum
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Contact:
- Felix van Lier
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Principal Investigator:
- Felix van Lier
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Uden, Netherlands
- Recruiting
- Bernhoven Hospital
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Contact:
- Hester Hoogenboom
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Principal Investigator:
- Hester Hoogenboom
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 98 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Scheduled for open abdominal surgery
- High or intermediate risk for postoperative pulmonary complications according to ARISCAT score [J.Canet et al, Anesthesiology 2010;113]
- General anesthesia
Exclusion Criteria:
- Laparoscopic surgery
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 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.
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Patients are randomized and intra-operatively ventilated with an individualized high PEEP strategy (Highest PEEP with the lowest driving pressure with recruitment maneuvers)
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No Intervention: 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)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of participants developing one or more postoperative pulmonary complications (PPCs)
Time Frame: The first 5 postoperative days
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Severe respiratory failure; ARDS; Suspected pulmonary infection; Pulmonary infiltrate ; Pleural effusion; Atelectasis; Pneumothorax; Bronchospasm; Aspiration pneumonitis; Cardiopulmonary edema
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The first 5 postoperative days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of mild respiratory failures
Time Frame: The first 5 postoperative days
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Defined as a PaO2 < 60 mmHg (or < 7.9 kPa) or SpO2 < 90% in room air, but responding to supplemental oxygen (excluding hypoventilation)
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The first 5 postoperative days
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Proportion of participants developing one or more post-operative extra-pulmonary complications
Time Frame: The first 5 postoperative days
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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])
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The first 5 postoperative days
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Rate of intra-operative complications
Time Frame: For the length of the anesthesia, which will be estimated 2 to 5 hours.
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For the length of the anesthesia, which will be estimated 2 to 5 hours.
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The total amount and type of intraoperative fluid administration
Time Frame: For the length of the anesthesia, which will be estimated 2 to 5 hours
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Type of fluids: colloids, crystalloids or blood products
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For the length of the anesthesia, which will be estimated 2 to 5 hours
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Rate of all-cause mortality and in-hospital mortality
Time Frame: Postoperative day 5, day 30 and day 90
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Postoperative day 5, day 30 and day 90
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Length of hospital stay
Time Frame: From the day of surgery until the day of discharge, up to day 90
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From the day of surgery until the day of discharge, up to day 90
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Number of participants with an unscheduled Intensive Care Unit (ICU) (re-) admission and length of stay in Intensive care unit
Time Frame: From the day of surgery until the day of discharged, up to day 90
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From the day of surgery until the day of discharged, up to day 90
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Assessment of postoperative wound healing
Time Frame: The first 5 postoperative days
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Visual inspection of the following: impairment of wound healing and/or wound infection;
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The first 5 postoperative days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Marcus J. Schultz, MD PhD, Department of Intensive Care
- Principal Investigator: Markus W. Hollmann, MD PhD, Department of Anesthesiology
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 23, 2019
Primary Completion (Estimated)
January 1, 2024
Study Completion (Estimated)
March 1, 2024
Study Registration Dates
First Submitted
November 2, 2018
First Submitted That Met QC Criteria
March 20, 2019
First Posted (Actual)
March 21, 2019
Study Record Updates
Last Update Posted (Estimated)
January 15, 2024
Last Update Submitted That Met QC Criteria
January 12, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- DESIGNATION
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Individualized high PEEP strategy
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Academisch Medisch Centrum - Universiteit van Amsterdam...University Medical Center Groningen; Maastricht University Medical Center; Medical... and other collaboratorsRecruitingPostoperative Complications | SurgeryNetherlands
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RWTH Aachen UniversityWithdrawnInvasive Mechanical Ventilation | Severe Acute Respiratory Distress Syndrome / Severe ARDS | Individualized PEEP Treatment Strategy
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Beth Israel Deaconess Medical CenterNational Heart, Lung, and Blood Institute (NHLBI)CompletedAcute Respiratory Distress SyndromeUnited States, Canada
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Peking Union Medical College HospitalCompleted
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Dionne PeacherWithdrawnLung Diseases | Obesity | One-Lung VentilationUnited States