Personalized mechanical ventilation using ultrasound for patients with ARDS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 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's running

• 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

Study contacts

• Principal investigator: Lieuwe DJ Bos, Dr. — Amsterdam UMC, location AMC
• Study coordinator: Jante S Sinnige, M.D.
• Email: j.s.sinnige@amsterdamumc.nl
• Phone: +31637405311

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Inspiratory Effort and Dyspnea During Assisted Mechanical Ventilation in Critically Ill Adults

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• FCV vs VC—Obese Adults Undergoing Laparoscopic Surgery

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.