Welcome to the GENERATOR study page

The “Driving Pressure During General Anesthesia for Minimally Invasive Abdominal Surgery (GENERATOR)” study is a multicenter international RCT. On this webpage you can find study information for participating researchers and interested parties.


13 februari 2024

GENERATOR is looking for participating centers

The GENERATOR study has started recruiting patients in multiple centers and is looking for participating centers in the Netherlands and beyond. Interested? Contact us at generator@amsterdamumc.nl or use the contact form below!

Currently recruiting centers

  • 7 centers in the Netherlands (Amsterdam UMC, Maasstad Ziekenhuis, Dijklander Ziekenhuis, HAGA ziekenhuis, Maastricht UMC, Onze Lieve Vrouwe Gasthuis, Zaans Medisch Centrum)

Countries/sites that are applying for ethical approval

  • Austria, Italy, Spain, Germany
  • 9 centers in the Netherlands

Study Summary


The intraoperative driving pressure (ΔP) has an independent association with the development of postoperative pulmonary complications (PPCs) in patients receiving ventilation during general anesthesia for major surgery. Ventilation with high intraoperative positive end–expiratory pressure (PEEP) with recruitment maneuvers (RMs) that results in a low ΔP has the potential to prevent PPCs.

Study design

The GENERATOR study is an investigator−initiated multicenter double blind international randomized.

Study population

This study will include 1806 patients scheduled for major minimally invasive abdominal surgery and with an increased risk of PPCs based on: (i.) the ARISCAT risk score for PPCs (≥ 26 points), or (ii.): a combination of age > 40 years, scheduled surgery lasting > 2 hours and planned to receive an intra–arterial catheter for blood pressure monitoring during surgery.


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.

Main study parameters/endpoints

The primary outcome is a collapsed composite endpoint of PPCs until postoperative day five. Secondary outcomes are intraoperative complications, extrapulmonary postoperative complications, length of hospital stay and related healthcare costs.



Call for centers

We are currently looking for centers in the Netherlands that would like to collaborate in the GENERATOR study. You may contact the GENERATOR steering committee via the contact form.

Formulier Afbeelding

Contact Us

Study team

Steering committee

Markus Hollmann Sabrine Hemmes
Marcus Schultz Tom Vermeulen
David van Meenen Galina Dorland

Data and Safety Monitoring Board

Prof. Idit Matot (chair)

Department of Anesthesiology, Intensive Care and Pain at the Tel Aviv Medical Center, Israel.

Dr. Martin Scharffenberg

Department of Anesthesiology, Universitätsklinikum Carl Gustav Carus Dresden, Germany

Dr. Francesca Rubulotta

Department of Critical Care Medicine, McGill University’s Faculty of Medicine and Health Sciences, Montreal, Canada

Prof. John Laffey

Department of Anaesthesia and Intensive Care Medicine at the School of Medicine of the University of Galway, Ireland

Prof. Patrick Schober (independent statistician)

Department of Anesthesiology, Amsterdam University Medical Centers, Amsterdam, the Netherlands



The eCRF is built in Castor EDC, a program that can be reached from everywhere via the internet. Randomization and reporting of protocol deviations will also be performed in this system.

Trial registration

Registration of the GENERATOR study at clinicaltrials.gov.


Participate in GENERATOR