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

Recruiting now · Not applicable

Conditions studied: ARDS, Human, Lung Ultrasound, Mechanical Ventilation

In brief

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.

Key facts

Study ID

NCT05492344

Run by

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

People needed

538

Starts

2022-08-09

Expected to finish

2027-11-01

Last updated by the study team

2026-05-27

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Admitted to a participating ICU,
• invasively ventilated and
• fulfil the Berlin criteria for moderate or severe ARDS.

You may not qualify if…

• Age under 18,
• participation in other interventional studies with conflicting endpoints,
• conditions in which LUS is not feasible or possible (e.g. subcutaneous emphysema, morbid obesity or wounds),
• mechanical ventilation for longer than 7 consecutive days in the past 30 days,
• history of ARDS in the previous month,
• body-mass index higher than 40 kg/m²,
• intracranial hypertension,
• broncho-pleural fistula,
• chronic respiratory diseases requiring long-term oxygen therapy or respiratory support,
• pulmonary fibrosis with a vital capacity < 50% (severe or very severe),
• previously randomized in the PEGASUS study
• ECMO
• patients who receive invasive ventilation in home setting due to a neurological disease
• pregnant patients
• patients who are moribund or facing end of life and
• no informed consent.

Where it is running

• Chu-Brugmann — Brussels, Belgium (enrolling)
• Bispebjerg Hospital — Copenhagen, Denmark (enrolling)
• Nordsjaellands Hospital — Hillerød, Denmark (enrolling)
• Evaggelismos Hospital — Athens, Greece (enrolling)
• Galway University Hospitals — Galway, Ireland (enrolling)
• Ospedale Generale Regionale F. Miulli — Acquaviva delle Fonti, Bari, Italy (enrolling)
• Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari — Bari, Italy (enrolling)
• Amsterdam UMC, location VUmc — Amsterdam, North Holland, Netherlands (enrolling)
• Amsterdam UMC, location AMC — Amsterdam, North Holland, Netherlands (enrolling)
• Centralny Szpital Kliniczny MSWiA — Warsaw, Poland (enrolling)

Full record on ClinicalTrials.gov

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