Driving Pressure During General Anesthesia for Minimally Invasive Abdominal Surgery (GENERATOR)

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 Positive End Expiratory Pressure (PEEP) strategy with recruitment maneuvers, aiming at avoiding an increase in the driving pressure during intraoperative ventilation, protects against the development of postoperative pulmonary complications in patients undergoing minimally invasive abdominal surgery.

Conditions

• Postoperative Complications
• Surgery

Interventions

PROCEDURE

Intraoperative ventilation with individualized high PEEP titrated to the lowest ΔP with RMs

The intervention is intraoperative ventilation using the available ventilator with individualized high PEEP titrated to the lowest ΔP with RMs. After abdominal insufflation, patients randomized to the individualized high PEEP with RMs group will receive a RM followed by a 'decremental PEEP trial'. This is followed by a second RM after which PEEP is set at the level indicated by the decremental PEEP trial

Sponsors & Collaborators

• Onze Lieve Vrouwe Gasthuis

  collaborator OTHER

• HagaZiekenhuis

  collaborator OTHER

• Dijklander Ziekenhuis

  collaborator OTHER

• The Netherlands Cancer Institute

  collaborator OTHER

• Isala

  collaborator OTHER

• Maasstad Hospital

  collaborator OTHER

• Medisch Spectrum Twente

  collaborator OTHER

• University Medical Center Groningen

  collaborator OTHER

• Leiden University Medical Center

  collaborator OTHER

• Hospital Universitario La Fe

  collaborator OTHER

• Ospedale Policlinico San Martino

  collaborator OTHER

• University Hospital Carl Gustav Carus

  collaborator OTHER

• Medical University Innsbruck

  collaborator OTHER

• Spaarne Gasthuis

  collaborator OTHER

• Zaans Medical Center

  collaborator OTHER

• Alrijne Hospital

  collaborator OTHER

• Albert Schweitzer Hospital

  collaborator OTHER

• Maastricht University Medical Center

  collaborator OTHER

• Noordwest Ziekenhuisgroep

  collaborator OTHER

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

  lead OTHER

Principal Investigators

• Marcus Schultz, Professor · Amsterdam University Medical Center, location AMC

• Markus Hollmann, Professor · Amsterdam University Medical Center, location AMC

• David van Meenen, PhD · Amsterdam University Medical Center, location AMC

• Sabrine Hemmes, PhD · Amsterdam University Medical Center, location AMC

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

2023-12-11

Primary Completion

2027-06-01

Completion

2027-09-01

Countries

• Netherlands

Study Locations