Postoperative Respiratory ComplicationDESIGNATIONNCT03884543
Driving Pressure During General Anesthesia for Open Abdominal Surgery
A study testing Individualized high PEEP strategy in people with Postoperative Respiratory Complication, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 22 sites in 3 countries.
Trial 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 PEEP strategy, aiming at avoiding an increase in the driving pressure during intraoperative ventilation, protects against the development of… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Postoperative Respiratory Complication
- What is being tested?
- Individualized high PEEP strategy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,468 participants
- Where
- 22 sitesin 3 countries
- Study dates
- 23 Apr 2019to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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
Trial locations and contacts
22 sites in 3 countries.
22 sites in 3 countries
Netherlands17 sites
Noordwest ziekenhuizengroep Alkmaar
Alkmaar
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Amsterdam
Amsterdam UMC location VUmc
Amsterdam
Onze Lieve Vrouwen Gasthuis
Amsterdam
Rijnstate Hospital
Arnhem
Albert Schweitzer Ziekenhuis
Dordrecht
Martini Hospital
Groningen
UMC Groningen
Groningen
Spaarne Gasthuis Hospital
Haarlem
Medical Center Leeuwarden
Leeuwarden
Leiden UMC
Leiden
Maastricht UMC
Maastricht
Radboud UMC
Nijmegen
Erasmus Medisch Centrum
Rotterdam
Haaglanden Medisch Centrum
The Hague
HAGA
The Hague
Bernhoven Hospital
Uden
Germany3 sites
University hospital Carl Gustav Carus
Dresden
Heinrich-Heine University Hospital Dusseldorf
Düsseldorf
Bermanntrost BG Klinikum Halle
Halle
Italy2 sites
Ospedale Policlinico San Martino
Genoa
University hospital Napoli
Naples
About this study
Official title: 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.
- Conditions
- Postoperative Respiratory Complication
- Being tested
- Individualized high PEEP strategy
- Keywords
- Mechanical ventilation, Positive end-expiratory pressure, Driving pressure, Post-operative postoperative complications, Open abdominal surgery, Recruitment maneuver, PEEP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized high PEEP strategyProcedure or surgery
Patients are randomized and intra-operatively ventilated with an individualized high PEEP strategy (Highest PEEP with the lowest driving pressure with recruitment maneuvers)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Individualized high PEEP strategy |
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: The first 5 postoperative days
Secondary outcomes (8)
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)
Measured: The first 5 postoperative days
Proportion of participants developing one or more post-operative extra-pulmonary complications
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])
Measured: The first 5 postoperative days
Rate of intra-operative complications
Measured: 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
Measured: For the length of the anesthesia, which will be estimated 2 to 5 hours
Rate of all-cause mortality and in-hospital mortality
Measured: Postoperative day 5, day 30 and day 90
Length of hospital stay
Measured: 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
Measured: 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;
Measured: The first 5 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start23 Apr 2019
- Primary completion11 Mar 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative Respiratory ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,468 participants (actual)
Sponsor and investigators
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Sponsor type
- University, hospital or other
- Collaborators
- Amsterdam UMC, location VUmc, Noord West Ziekenhuizen location Alkmaar, University Medical Center Groningen, Radboud University Medical Center, HagaZiekenhuis, Rijnstate Hospital, Medical Center Haaglanden, Bernhoven Hospital, Onze Lieve Vrouwe Gasthuis, Albert Schweitzer Hospital, Frisius Medisch Centrum, Leiden University Medical Center, Maastricht University Medical Center, Martini Hospital Groningen, Erasmus Medical Center, Spaarne Gasthuis, University Hospital Carl Gustav Carus, Bermanntrost BG Klinikum Halle, Heinrich-Heine University, Duesseldorf, Ospedale Policlinico San Martino, Jeroen Bosch Ziekenhuis, Meander Medical Center, Isala, Alrijne Hospital, Antoni van Leeuwenhoek Ziekenhuis, Medisch Spectrum Twente, Campus Bio-Medico University, Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale, University of Roma La Sapienza, University of Campania Luigi Vanvitelli, Hospital Universitario La Fe, Medical University Innsbruck
- Responsible party
- Principal investigator, Prof. Dr. Marcus J. Schultz, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Marcus J. Schultz, MD PhD, Principal investigator, Department of Intensive CareMarkus W. Hollmann, MD PhD, Principal investigator, Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03884543
- Sponsor's protocol ID
- DESIGNATION
- Acronym
- DESIGNATION
- Status last verified
- Nov 2025
- First submitted
- 2 Nov 2018
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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.
PubMed 17331245Writing 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.
PubMed 41334859DESIGNATION-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.
PubMed 32070400
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Driving Pressure During General Anesthesia for Open Abdominal Surgery (DESIGNATION) - a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03884543
- Acronym / sponsor ID
- DESIGNATION / DESIGNATION
- Conditions
- Postoperative Respiratory Complication
- Keywords
- Mechanical ventilation, Positive end-expiratory pressure, Driving pressure, Post-operative postoperative complications, Open abdominal surgery, Recruitment maneuver, PEEP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,468 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Amsterdam UMC, location VUmc, Noord West Ziekenhuizen location Alkmaar, University Medical Center Groningen, Radboud University Medical Center, HagaZiekenhuis, Rijnstate Hospital, Medical Center Haaglanden, Bernhoven Hospital, Onze Lieve Vrouwe Gasthuis, Albert Schweitzer Hospital, Frisius Medisch Centrum, Leiden University Medical Center, Maastricht University Medical Center, Martini Hospital Groningen, Erasmus Medical Center, Spaarne Gasthuis, University Hospital Carl Gustav Carus, Bermanntrost BG Klinikum Halle, Heinrich-Heine University, Duesseldorf, Ospedale Policlinico San Martino, Jeroen Bosch Ziekenhuis, Meander Medical Center, Isala, Alrijne Hospital, Antoni van Leeuwenhoek Ziekenhuis, Medisch Spectrum Twente, Campus Bio-Medico University, Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale, University of Roma La Sapienza, University of Campania Luigi Vanvitelli, Hospital Universitario La Fe, Medical University Innsbruck
- Study start
- 23 Apr 2019 (actual)
- Primary completion
- 11 Mar 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 21 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individualized high PEEP strategy | Experimental | Procedure: Individualized high PEEP strategyRecruitment 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) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- Laparoscopic surgery
- Surgery in prone or lateral position
- Combined procedure with open abdominal and intrathoracic surgery
- Body mass index > 40 kg/m2;
- Reported pregnancy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized high PEEP strategyPatients are randomized and intra-operatively ventilated with an individualized high PEEP strategy (Highest PEEP with the lowest driving pressure with recruitment maneuvers) | Procedure or surgery | Individualized high PEEP strategy |
Primary outcome
Proportion of participants developing one or more postoperative pulmonary complications (PPCs)
Time frame: The first 5 postoperative days
Severe respiratory failure; ARDS; Suspected pulmonary infection; Pulmonary infiltrate ; Pleural effusion; Atelectasis; Pneumothorax; Bronchospasm; Aspiration pneumonitis; Cardiopulmonary edema
8 secondary outcomes
Rate of mild respiratory failures
Time frame: The first 5 postoperative days
Proportion of participants developing one or more post-operative extra-pulmonary complications
Time frame: The first 5 postoperative days
Rate of intra-operative complications
Time frame: For the length of the anesthesia, which will be estimated 2 to 5 hours.
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
Rate of all-cause mortality and in-hospital mortality
Time frame: Postoperative day 5, day 30 and day 90
Length of hospital stay
Time frame: 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
Time frame: From the day of surgery until the day of discharged, up to day 90
Assessment of postoperative wound healing
Time frame: The first 5 postoperative days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Results publication: PubMed 17331245Mehta 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.
- Derived from this study: PubMed 41334859Writing 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.
- Derived from this study: PubMed 32070400DESIGNATION-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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcus J. Schultz, MD PhD principal investigator
Department of Intensive Care
Markus W. Hollmann, MD PhD principal investigator
Department of Anesthesiology
22 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized high PEEP strategy in people with Postoperative Respiratory Complication, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 22 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Netherlands, Germany, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants developing one or more postoperative pulmonary complications (PPCs) (time frame: The first 5 postoperative days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03884543, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.