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Completed

NCT Number: NCT03884543

Driving Pressure During General Anesthesia for Open Abdominal Surgery

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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Key information

Conditions

Postoperative Respiratory Complication

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University hospital Carl Gustav Carus, Dresden, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  1. 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

Secondary outcomes

  1. Rate of mild respiratory failures

    Time frame: The first 5 postoperative days

    Defined as a PaO2 < 60 mmHg (or < 7.9 kPa) or SpO2 < 90% in room air, but responding to supplemental oxygen (excluding hypoventilation)

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

    Time frame: The first 5 postoperative days

    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])

  3. Rate of intra-operative complications

    Time frame: For the length of the anesthesia, which will be estimated 2 to 5 hours.

  4. 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

    Type of fluids: colloids, crystalloids or blood products

  5. Rate of all-cause mortality and in-hospital mortality

    Time frame: Postoperative day 5, day 30 and day 90

  6. Length of hospital stay

    Time frame: From the day of surgery until the day of discharge, up to day 90

  7. 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

  8. Assessment of postoperative wound healing

    Time frame: The first 5 postoperative days

    Visual inspection of the following: impairment of wound healing and/or wound infection;

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

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

Registry information

Official study title

Driving Pressure During General Anesthesia for Open Abdominal Surgery (DESIGNATION) - a Randomized Clinical Trial

Acronym: DESIGNATION

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Mar 21, 2019
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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