NCT03884543

Brief 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 postoperative pulmonary complications.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,468

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2019

Longer than P75 for not_applicable

Geographic Reach
3 countries

22 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2018

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 21, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

April 23, 2019

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

5.9 years

First QC Date

November 2, 2018

Last Update Submit

November 17, 2025

Conditions

Postoperative Respiratory Complication

Keywords

Mechanical ventilationPositive end-expiratory pressureDriving pressurePost-operative postoperative complicationsOpen abdominal surgeryRecruitment maneuverPEEP

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (8)

  • Rate of mild respiratory failures

    The first 5 postoperative days

  • Proportion of participants developing one or more post-operative extra-pulmonary complications

    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

    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

  • +3 more secondary outcomes

Study Arms (2)

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.

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)

Interventions

Individualized high PEEP strategyPROCEDURE

Patients are randomized and intra-operatively ventilated with an individualized high PEEP strategy (Highest PEEP with the lowest driving pressure with recruitment maneuvers)

Individualized high PEEP strategy

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

University hospital Carl Gustav Carus

Dresden, Germany

Location

Heinrich-Heine University Hospital Dusseldorf

DĂ¼sseldorf, Germany

Location

Bermanntrost BG Klinikum Halle

Halle, Germany

Location

Ospedale Policlinico San Martino

Genoa, Italy

Location

University hospital Napoli

Napoli, Italy

Location

Noordwest ziekenhuizengroep Alkmaar

Alkmaar, Netherlands

Location

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Amsterdam, Netherlands

Location

Amsterdam UMC location VUmc

Amsterdam, Netherlands

Location

Onze Lieve Vrouwen Gasthuis

Amsterdam, Netherlands

Location

Rijnstate Hospital

Arnhem, Netherlands

Location

Albert Schweitzer Ziekenhuis

Dordrecht, Netherlands

Location

Martini Hospital

Groningen, Netherlands

Location

UMC Groningen

Groningen, Netherlands

Location

Spaarne Gasthuis Hospital

Haarlem, Netherlands

Location

Medical Center Leeuwarden

Leeuwarden, Netherlands

Location

Leiden UMC

Leiden, Netherlands

Location

Maastricht UMC

Maastricht, Netherlands

Location

Radboud UMC

Nijmegen, Netherlands

Location

Erasmus Medisch Centrum

Rotterdam, Netherlands

Location

Haaglanden Medisch Centrum

The Hague, Netherlands

Location

HAGA

The Hague, Netherlands

Location

Bernhoven Hospital

Uden, Netherlands

Location

Related Publications (3)

  • 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.

    PMID: 17331245RESULT

  • 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. 2025 Dec 3:e2523373. doi: 10.1001/jama.2025.23373. Online ahead of print.

    PMID: 41334859DERIVED

  • 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.

    PMID: 32070400DERIVED

Study Officials

  • Marcus J. Schultz, MD PhD

    Department of Intensive Care

    PRINCIPAL INVESTIGATOR

  • Markus W. Hollmann, MD PhD

    Department of Anesthesiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 2, 2018

First Posted

March 21, 2019

Study Start

April 23, 2019

Primary Completion

March 11, 2025

Study Completion

June 1, 2025

Last Updated

November 19, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

Locations

NL(17)DE(3)IT(2)