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Search / Trial NCT05492344

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

Launched by ACADEMISCH MEDISCH CENTRUM - UNIVERSITEIT VAN AMSTERDAM (AMC-UVA) · Aug 5, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to help patients with Acute Respiratory Distress Syndrome (ARDS), a serious condition that affects breathing and can lead to death. The researchers want to see if using lung ultrasound (a safe and non-invasive imaging technique) to personalize mechanical ventilation—machines that help people breathe—can improve patient outcomes compared to standard ventilation methods. The goal is to reduce the number of patients who die within 90 days of treatment.

To participate in this trial, patients need to be between the ages of 65 and 90 and must be receiving mechanical ventilation in an intensive care unit for moderate or severe ARDS. However, there are some exclusions, such as patients under 18, those with certain other medical conditions, or anyone who has been on mechanical ventilation for too long recently. Participants can expect to receive personalized care based on ultrasound results, which could potentially lead to better recovery outcomes. It’s important to note that participation is voluntary, and informed consent will be required before joining the study.

Gender

ALL

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.

About Academisch Medisch Centrum Universiteit Van Amsterdam (Amc Uva)

The Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) is a leading academic medical center in the Netherlands, dedicated to advancing healthcare through innovative research, education, and patient care. Affiliated with the University of Amsterdam, AMC-UvA integrates clinical practice with cutting-edge biomedical research, fostering a multidisciplinary approach to medical challenges. The institution actively engages in clinical trials to enhance treatment options and improve patient outcomes, while promoting collaboration among healthcare professionals, researchers, and academic institutions globally. With a commitment to excellence and a focus on translational medicine, AMC-UvA plays a pivotal role in shaping the future of healthcare.

Locations

Copenhagen, , Denmark

Warsaw, , Poland

Galway, , Ireland

Bari, , Italy

Hillerød, , Denmark

Amsterdam, Noord Holland, Netherlands

Amsterdam, Noord Holland, Netherlands

Acquaviva Delle Fonti, Bari, Italy

Bruxelles, , Belgium

Athens, , Greece

Patients applied

0 patients applied

Trial Officials

Lieuwe DJ Bos, Dr.

Principal Investigator

Amsterdam UMC, location AMC

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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