Actively Recruiting

Phase Not Applicable
Age: 18Years - 100Years
All Genders
NCT05492344

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 2025-12-08

538

Participants Needed

10

Research Sites

272 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Rationale 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. The investigators hypothesize that LUS-guided personalized mechanical ventilation in ARDS patients will lead to a reduction in 90-day mortality compared to conventional mechanical ventilation.

CONDITIONS

Official 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
  • Receiving invasive mechanical ventilation
  • Meet Berlin criteria for moderate or severe ARDS
Not Eligible

You will not qualify if you...

  • Under 18 years of age
  • Participating in other interventional studies with conflicting endpoints
  • Conditions making lung ultrasound not feasible (e.g., subcutaneous emphysema, morbid obesity, wounds)
  • Mechanical ventilation for more than 7 consecutive days in the 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 the PEGASUS study
  • Receiving extracorporeal membrane oxygenation (ECMO)
  • Moribund or near end of life
  • Lack of informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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Research Team

J

Jante S Sinnige, M.D.

CONTACT

M

Marry R Smit, Dr.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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