Welcome to the PEGASUS study page

The “Personalized Mechanical Ventilation Guided by UltraSound in Patients with Acute Respiratory Distress Syndrome (PEGASUS)” study is a multicenter international RCT. On this webpage you can find study information for participating researchers and interested parties.


6 januari 2023

Happy 2023!

Happy 2023 from the PEGASUS study team. We've started the new year with ethics approval in the Netherlands, Poland, Italy, Portugal, Denmark and Belgium! Early this year many centres in these countries will start patient inclusion. Based on the experience of the first 8 patients we included in Amsterdam, we are writing a detailed handbook on how to guide mechanical ventilation in PEGASUS patients.

28 oktober 2022

Co-investigator meeting for the PEGASUS study

The first PEGASUS co-investigator meeting has been planned for the 5th of December 2022.

17 oktober 2022

First patient in PEGASUS study

The first PEGASUS patient has been included in the Amsterdam UMC.

Currently recruiting centers

  • 2 centers in the Netherlands, 2 centers in Italy, 2 centers in Denmark, 1 center in Belgium, 1 center in Ireland, 1 center in Greece, 1 center in Poland, 2 centers in Portugal, 1 center in Spain
  • 76 patients included (April 2024)

Countries with ethics approval

  • Approval in: Netherlands, Italy, Poland, Portugal, Belgium, Bangladesh, Ireland, Spain and Denmark
  • Approval pending in: Sweden

Study Summary


Acute respiratory distress syndrome (ARDS) is a frequent cause of hypoxemic respiratory failure with a mortality rate of approximately 30%. The identification of ARDS phenotypes, based on focal or non-focal lung morphology, can be helpful to better target mechanical ventilation strategies of individual patients. Lung ultrasound (LUS) is a non-invasive tool that can accurately distinguish ‘focal’ from ‘non-focal’ lung morphology. We hypothesize that LUS-guided personalized mechanical ventilation in ARDS patients will lead to a reduction in 90-day mortality compared to conventional mechanical ventilation.


The aim of this study is to determine if personalized mechanical ventilation based on lung morphology assessed by LUS leads to a reduced mortality compared to conventional mechanical ventilation in ARDS patients.

Study design

The PEGASUS study is an international, investigator-initiated multicenter randomized clinical trial (RCT).

Study population

This study will include 538 consecutively admitted invasively ventilated adult intensive care unit (ICU) patients with moderate or severe ARDS.


Patients will receive a LUS exam within 12 hours after diagnosis of ARDS to classify lung morphology as focal or non-focal ARDS. Immediately after the LUS exam patients will be randomly assigned to the intervention group, with personalized mechanical ventilation, or the control group, in which patients will receive standard care. In the intervention group, patients with focal lung morphology will receive daily prone positioning with lower positive end-expiratory pressure (PEEP) and patients with non-focal lung morphology will receive daily recruitment maneuvers with higher PEEP.

Main study parameters/endpoints

The primary endpoint is all cause mortality at day 90 (diagnosis of ARDS considered as day 0). Secondary outcomes are mortality at 28 days, ventilator free days (VFD) at day 28, ICU length of stay, ICU mortality, hospital length of stay, hospital mortality and number of complications (VAP, pneumothorax and need for rescue therapy).



Call for centers

Formulier Afbeelding

Study team

Academic advisor

Data and Safety Monitoring Board

Prof. Danny McAuley, Head  of the DSMB

Royal Victoria Hospital and Queen's University of Belfast, Belfast, Ireland.

Dr. Dave Dongelmans

Amsterdam UMC, Amsterdam, the Netherlands

Dr. Rik Endeman

Erasmus MC, Rotterdam, the Netherlands

Dr. Ary Serpa Neto, independent statistician

Australian and New Zealand Intensive Care-Research Centre (ANZIC-RC), Melbourne, Australia

National Coordinators

Bangladesh: Prof. A. Faiz & Dr. L. Pisani Italy: Dr. C. Zimatore
Belgium: Dr. C. Pierrakos Portugal: Dr. P. Povoa
France: Prof. J-M. Constantin Poland: Dr. K. Szułdrzyński
Czech Republic: Dr. Petr Waldauf Denmark: Dr. T. Skovsgaard Itenov
Spain: Dr. O. Roca  
Ireland: Prof. J. Laffey  


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 PEGASUS study at clinicaltrials.gov.


Participate in PEGASUS


Feel free to contact us