Personalized mechanical ventilation using ultrasound for patients with ARDS

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

This study is testing if using lung ultrasound to personalize mechanical ventilation can help adults with severe ARDS live longer compared to standard care.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 538 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Academic / other)
• Locations: 10 sites (Brussels and 9 other locations)
• Trial ID: NCT05492344 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of personalized mechanical ventilation guided by lung ultrasound (LUS) in patients diagnosed with acute respiratory distress syndrome (ARDS). The study will include 538 adult patients who are invasively ventilated and meet the criteria for moderate or severe ARDS. Participants will undergo a LUS exam to classify their lung morphology, after which they will be randomly assigned to receive either personalized ventilation based on their LUS results or standard care. The primary goal is to determine if this tailored approach can reduce 90-day mortality compared to conventional methods.

Who should consider this trial

Good fit: Ideal candidates are adult patients admitted to an ICU who are invasively ventilated and meet the Berlin criteria for moderate or severe ARDS.

Not a fit: Patients who may not benefit include those under 18, with certain medical conditions that make LUS infeasible, or those with a history of ARDS in the previous month.

Why it matters

Potential benefit: If successful, this approach could significantly lower mortality rates in ARDS patients by optimizing mechanical ventilation strategies.

How similar studies have performed: While the use of LUS in guiding treatment is promising, this specific approach to personalized mechanical ventilation in ARDS is novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

* 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 are moribund or facing end of life and
* no informed consent.

Where this trial is running

Brussels and 9 other locations

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

Study contacts

• Principal investigator: Lieuwe DJ Bos, Dr. — Amsterdam UMC, location AMC
• Study coordinator: Jante S Sinnige, M.D.

Conditions ARDS, Human; Lung Ultrasound; Mechanical Ventilation