Driving Pressure During General Anesthesia for Open Abdominal Surgery

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.

Conditions

• Postoperative Respiratory Complication

Interventions

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)

Sponsors & Collaborators

• Amsterdam UMC, location VUmc

  collaborator OTHER

• Noord West Ziekenhuizen location Alkmaar

  collaborator UNKNOWN

• University Medical Center Groningen

  collaborator OTHER

• Radboud University Medical Center

  collaborator OTHER

• HagaZiekenhuis

  collaborator OTHER

• Rijnstate Hospital

  collaborator OTHER

• Medical Center Haaglanden

  collaborator OTHER

• Bernhoven Hospital

  collaborator OTHER

• Onze Lieve Vrouwe Gasthuis

  collaborator OTHER

• Albert Schweitzer Hospital

  collaborator OTHER

• Frisius Medisch Centrum

  collaborator OTHER

• Leiden University Medical Center

  collaborator OTHER

• Maastricht University Medical Center

  collaborator OTHER

• Martini Hospital Groningen

  collaborator OTHER

• Erasmus Medical Center

  collaborator OTHER

• Spaarne Gasthuis

  collaborator OTHER

• University Hospital Carl Gustav Carus

  collaborator OTHER

• Bermanntrost BG Klinikum Halle

  collaborator UNKNOWN

• Heinrich-Heine University, Duesseldorf

  collaborator OTHER

• Ospedale Policlinico San Martino

  collaborator OTHER

• Jeroen Bosch Ziekenhuis

  collaborator OTHER

• Meander Medical Center

  collaborator OTHER

• Isala

  collaborator OTHER

• Alrijne Hospital

  collaborator OTHER

• Antoni van Leeuwenhoek Ziekenhuis

  collaborator UNKNOWN

• Medisch Spectrum Twente

  collaborator OTHER

• Campus Bio-Medico University

  collaborator OTHER

• Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale

  collaborator NETWORK

• University of Roma La Sapienza

  collaborator OTHER

• University of Campania Luigi Vanvitelli

  collaborator OTHER

• Hospital Universitario La Fe

  collaborator OTHER

• Medical University Innsbruck

  collaborator OTHER

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

  lead OTHER

Principal Investigators

• Marcus J. Schultz, MD PhD · Department of Intensive Care

• Markus W. Hollmann, MD PhD · Department of Anesthesiology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-04-23

Primary Completion

2025-03-11

Completion

2025-06-01

Countries

• Germany
• Italy
• Netherlands

Study Locations