Driving Pressure During General Anesthesia for Open Abdominal Surgery (DESIGNATION)

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: Completed
• Conditions: Postoperative Respiratory Complication
• Intervention / Treatment: Procedure: Individualized high PEEP strategy

• Study Type: Interventional
• Enrollment (Actual): 1468
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Dresden, Germany
    • University Hospital Carl Gustav Carus
  • Düsseldorf, Germany
    • Heinrich-Heine University Hospital Dusseldorf
  • Halle, Germany
    • Bermanntrost BG Klinikum Halle
• Italy
  • Genoa, Italy
    • Ospedale Policlinico San Martino
  • Napoli, Italy
    • University hospital Napoli
• Netherlands
  • Alkmaar, Netherlands
    • Noordwest ziekenhuizengroep Alkmaar
  • Amsterdam, Netherlands
    • Onze Lieve Vrouwen Gasthuis
  • Amsterdam, Netherlands
    • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • Amsterdam, Netherlands
    • Amsterdam UMC location VUmc
  • Arnhem, Netherlands
    • Rijnstate Hospital
  • Dordrecht, Netherlands
    • Albert Schweitzer Ziekenhuis
  • Groningen, Netherlands
    • UMC Groningen
  • Groningen, Netherlands
    • Martini Hospital
  • Haarlem, Netherlands
    • Spaarne Gasthuis Hospital
  • Leeuwarden, Netherlands
    • Medical Center Leeuwarden
  • Leiden, Netherlands
    • Leiden UMC
  • Maastricht, Netherlands
    • Maastricht UMC
  • Nijmegen, Netherlands
    • Radboud UMC
  • Rotterdam, Netherlands
    • Erasmus Medisch Centrum
  • The Hague, Netherlands
    • Haga
  • The Hague, Netherlands
    • Haaglanden Medisch Centrum
  • Uden, Netherlands
    • Bernhoven Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 96 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Procedure: 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)
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)

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)	Severe respiratory failure; ARDS; Suspected pulmonary infection; Pulmonary infiltrate ; Pleural effusion; Atelectasis; Pneumothorax; Bronchospasm; Aspiration pneumonitis; Cardiopulmonary edema	The first 5 postoperative days

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Collaborators: Radboud University Medical Center; University of Roma La Sapienza; University Medical Center Groningen; Maastricht University Medical Center; Erasmus Medical Center; Heinrich-Heine University, Duesseldorf; Amsterdam UMC, location VUmc; Medical University Innsbruck; Leiden University Medical Center; Medical Center Haaglanden; Campus Bio-Medico University; Hospital Universitario La Fe; Albert Schweitzer Hospital; Rijnstate Hospital; Onze Lieve Vrouwe Gasthuis; Spaarne Gasthuis; Jeroen Bosch Ziekenhuis; Isala; Meander Medical Center; Ospedale Policlinico San Martino; Martini Hospital Groningen; Bernhoven Hospital; Medisch Spectrum Twente; University Hospital Carl Gustav Carus; Alrijne Hospital; Noord West Ziekenhuizen location Alkmaar; HagaZiekenhuis; Bermanntrost BG Klinikum Halle; Antoni van Leeuwenhoek Ziekenhuis; Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale; University of Campania Luigi Vanvitelli; Frisius Medisch Centrum
• 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

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

Study Major Dates

• Study Start (Actual): April 23, 2019
• Primary Completion (Actual): March 11, 2025
• Study Completion (Actual): June 1, 2025

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): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Mechanical ventilation; PEEP; Positive end-expiratory pressure; Recruitment maneuver; Open abdominal surgery; Driving pressure; Post-operative postoperative complications
• 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