Actively Recruiting

Phase Not Applicable
Age: 18Years - 100Years
All Genders
ID05492344

Personalized Mechanical Ventilation Guided by UltraSound in Patients With Acute Respiratory Distress Syndrome

Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2026-05-27

538

Participants Needed

10

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating if personalized mechanical ventilation guided by lung ultrasound (LUS) can reduce mortality in adult patients with moderate or severe acute respiratory distress syndrome (ARDS). ARDS is a serious condition causing low oxygen levels with a high death rate, and identifying lung types as focal or non-focal using LUS may allow tailored ventilation strategies. This multicenter randomized clinical trial aims to compare this personalized approach with standard mechanical ventilation practices. Participants will receive a lung ultrasound exam within 12 hours of ARDS diagnosis to classify lung morphology. Patients will then be randomly assigned either to a group receiving personalized ventilation adjusting settings based on lung type or to a control group receiving standard care ventilation. Personalized ventilation includes specific settings for focal or non-focal ARDS, such as tidal volume, positive end-expiratory pressure (PEEP), daily positioning, and repeated ultrasound assessments. The control group will receive ventilation based on established guidelines including standard tidal volume and oxygen settings. Throughout the study, researchers will monitor all-cause mortality at 90 days as the primary outcome. Additional outcomes include mortality at 28 days, ventilator-free days, ICU and hospital length of stay, mortality, and complications like pneumonia or pneumothorax. The study includes safety and feasibility evaluations after the first 80 patients, with data collected from medical records and regular ultrasound exams. Participation involves standard ICU care procedures, and the burden or risks related to the study interventions are considered low.

CONDITIONS

Brief Title

Personalized Mechanical Ventilation Guided by UltraSound in Patients With Acute Respiratory Distress Syndrome

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Admitted to a participating ICU
  • Invasively ventilated
  • Meet Berlin criteria for moderate or severe ARDS
  • Age 18 years or older
  • Provide informed consent
Not Eligible

You will not qualify if you...

  • Under 18 years of age
  • Participation in other interventional studies with conflicting endpoints
  • Conditions preventing lung ultrasound (e.g., subcutaneous emphysema, morbid obesity, wounds)
  • Mechanical ventilation for more than 7 consecutive days in past 30 days
  • History of ARDS in the previous month
  • Body mass index over 40 kg/m2
  • Intracranial hypertension
  • Broncho-pleural fistula
  • Chronic respiratory diseases needing long-term oxygen or respiratory support
  • Pulmonary fibrosis with vital capacity less than 50%
  • Previously randomized in this study
  • Receiving extracorporeal membrane oxygenation (ECMO)
  • Invasive ventilation at home due to neurological disease
  • Pregnancy
  • Moribund or facing end of life
  • Lack of informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 90 days from diagnosis of ARDS

Participants receive mechanical ventilation personalized by lung ultrasound assessment or standard care according to random assignment. Lung ultrasound exams are performed within 12 hours after ARDS diagnosis and repeated every 48 to 72 hours for those with focal ARDS to guide ventilator settings.

Initial ultrasound and ventilation settings plus ultrasound reassessments every 48 to 72 hours for some participants

Follow-up

Duration - Up to 90 days after inclusion

Participants are monitored for outcomes including mortality, ventilator-free days, ICU and hospital length of stay, and complications up to 90 days after inclusion.

Visits and assessments as part of hospital and ICU stay monitoring

Trial Site Locations

Total: 10 locations

1

Chu-Brugmann

Brussels, Belgium

Actively Recruiting

2

Bispebjerg Hospital

Copenhagen, Denmark

Actively Recruiting

3

Nordsjaellands Hospital

Hillerød, Denmark

Actively Recruiting

4

Evaggelismos Hospital

Athens, Greece

Actively Recruiting

5

Galway University Hospitals

Galway, Ireland

Actively Recruiting

6

Ospedale Generale Regionale F. Miulli

Acquaviva delle Fonti, Bari, Italy

Actively Recruiting

7

Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

Bari, Italy

Actively Recruiting

8

Amsterdam UMC, location VUmc

Amsterdam, North Holland, Netherlands, 1081HV

Actively Recruiting

9

Amsterdam UMC, location AMC

Amsterdam, North Holland, Netherlands, 1105 AZ

Actively Recruiting

10

Centralny Szpital Kliniczny MSWiA

Warsaw, Poland

Actively Recruiting

Loading map...

Research Team

J

Jante S Sinnige, M.D.

M

Marry R Smit, Dr.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

Similar Trials

Alveolar Macrophage Programming Following Endotoxin Exposure

ARDS, Human

Actively Recruiting

1 location

The PEARL Trial: Randomized Study of Warm Lactated Ringer's ...

Neonatal Respiratory Distress Related Conditions

Actively Recruiting

1 location

Analgesia-First Sedation in Trauma Patients Comparing Interm...

Mechanical Ventilation

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Personalized mechanical ventilation guided by lung ultrasound in patients with ARDS: a pilot phase of a randomized clinical trial.

Jante S Sinnige, Marry R Smit, Mohammad J Alam...

https://pubmed.ncbi.nlm.nih.gov/41423518

Personalized mechanical ventilation guided by ultrasound in patients with acute respiratory distress syndrome (PEGASUS): study protocol for an international randomized clinical trial.

Jante S Sinnige, Marry R Smit, Aniruddha Ghose...

https://pubmed.ncbi.nlm.nih.gov/38715118