Personalized mechanical ventilation guided by ultrasound in patients with acute respiratory distress syndrome (PEGASUS): study protocol for an international randomized clinical trial
Issued Date
2024-12-01
Resource Type
eISSN
17456215
Scopus ID
2-s2.0-85192437746
Journal Title
Trials
Volume
25
Issue
1
Rights Holder(s)
SCOPUS
Bibliographic Citation
Trials Vol.25 No.1 (2024)
Suggested Citation
Sinnige J.S., Smit M.R., Ghose A., de Grooth H.J., Itenov T.S., Ischaki E., Laffey J., Paulus F., Póvoa P., Pierrakos C., Pisani L., Roca O., Schultz M.J., Szuldrzynski K., Tuinman P.R., Zimatore C., Bos L.D.J. Personalized mechanical ventilation guided by ultrasound in patients with acute respiratory distress syndrome (PEGASUS): study protocol for an international randomized clinical trial. Trials Vol.25 No.1 (2024). doi:10.1186/s13063-024-08140-7 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/98332
Title
Personalized mechanical ventilation guided by ultrasound in patients with acute respiratory distress syndrome (PEGASUS): study protocol for an international randomized clinical trial
Author's Affiliation
Mahidol Oxford Tropical Medicine Research Unit
School of Medicine
University Hospital Galway
NOVA Medical School - Faculdade de Ciências Médicas, Universidade Nova de Lisboa
Centre Hospitalier Universitaire Brugmann, Brussels
Københavns Universitet
Universitat Autònoma de Barcelona
Università degli studi di Bari Aldo Moro
Odense Universitetshospital
Copenhagen University Hospital
Nuffield Department of Medicine
Vrije Universiteit Amsterdam
Universiteit van Amsterdam
Hospital São Francisco Xavier
Parc Taulí Hospital Universitari
Chattogram Medical College Hospital
Central Clinical Hospital of the Ministry of the Interior and Administration
School of Medicine
University Hospital Galway
NOVA Medical School - Faculdade de Ciências Médicas, Universidade Nova de Lisboa
Centre Hospitalier Universitaire Brugmann, Brussels
Københavns Universitet
Universitat Autònoma de Barcelona
Università degli studi di Bari Aldo Moro
Odense Universitetshospital
Copenhagen University Hospital
Nuffield Department of Medicine
Vrije Universiteit Amsterdam
Universiteit van Amsterdam
Hospital São Francisco Xavier
Parc Taulí Hospital Universitari
Chattogram Medical College Hospital
Central Clinical Hospital of the Ministry of the Interior and Administration
Corresponding Author(s)
Other Contributor(s)
Abstract
Background : Acute respiratory distress syndrome (ARDS) is a frequent cause of hypoxemic respiratory failure with a mortality rate of approximately 30%. Identifying ARDS subphenotypes based on “focal” or “non-focal” lung morphology has the potential to better target mechanical ventilation strategies of individual patients. However, classifying morphology through chest radiography or computed tomography is either inaccurate or impractical. Lung ultrasound (LUS) is a non-invasive bedside tool that can accurately distinguish “focal” from “non-focal” lung morphology. We hypothesize that LUS-guided personalized mechanical ventilation in ARDS patients leads to a reduction in 90-day mortality compared to conventional mechanical ventilation. Methods: The Personalized Mechanical Ventilation Guided by UltraSound in Patients with Acute Respiratory Distress Syndrome (PEGASUS) study is an investigator-initiated, international, randomized clinical trial (RCT) that plans to enroll 538 invasively ventilated adult intensive care unit (ICU) patients with moderate to severe ARDS. Eligible patients will receive a LUS exam to classify lung morphology as “focal” or “non-focal”. Thereafter, patients will be randomized within 12 h after ARDS diagnosis to receive standard care or personalized ventilation where the ventilation strategy is adjusted to the morphology subphenotype, i.e., higher positive end-expiratory pressure (PEEP) and recruitment maneuvers for “non-focal” ARDS and lower PEEP and prone positioning for “focal” ARDS. The primary endpoint is all-cause mortality at day 90. Secondary outcomes are mortality at day 28, ventilator-free days at day 28, ICU length of stay, ICU mortality, hospital length of stay, hospital mortality, and number of complications (ventilator-associated pneumonia, pneumothorax, and need for rescue therapy). After a pilot phase of 80 patients, the correct interpretation of LUS images and correct application of the intervention within the safe limits of mechanical ventilation will be evaluated. Discussion: PEGASUS is the first RCT that compares LUS-guided personalized mechanical ventilation with conventional ventilation in invasively ventilated patients with moderate and severe ARDS. If this study demonstrates that personalized ventilation guided by LUS can improve the outcomes of ARDS patients, it has the potential to shift the existing one-size-fits-all ventilation strategy towards a more individualized approach. Trial registration: The PEGASUS trial was registered before the inclusion of the first patient, https://clinicaltrials.gov/ (ID: NCT05492344).