Clinical trial Recruiting at 2 sites Observational Ages 18 and up

Using imaging to assess risk of lung injury in ARDS patients

Official title: Artificial Intelligence-based Identification of Imaging Biomarkers of Lung FRAILty in Patients With Acute Respiratory Distress Syndrome.

Run by Università Vita-Salute San Raffaele · NCT05816954 · Data updated 2026-11-12

This study is testing if using advanced imaging can help doctors spot lung problems early in patients with acute respiratory distress syndrome (ARDS) to better manage their care.

More Acute Respiratory Distress Syndrome trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment100 (estimated)
SponsorUniversità Vita-Salute San Raffaele
Academic / other
Locations2 sites (Catanzaro, Calabria and 1 other locations)
StatusRecruiting
StartedAugust 30, 2023
Main results expectedApril 30, 2027
Study endsJuly 31, 2027
Registry record updatedAugust 6, 2025
Trial IDNCT05816954 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are patients diagnosed with ARDS who require ICU admission and can provide informed consent.

Probably not a fit

Patients with poor quality imaging due to motion or respiratory artifacts may not benefit from this study.

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

What this trial studies

This observational study aims to evaluate the Macklin effect as a predictor of barotrauma in patients with acute respiratory distress syndrome (ARDS), both related to COVID-19 and non-COVID-19 causes. The researchers will utilize artificial intelligence to identify imaging biomarkers that can non-invasively assess lung frailty in a mixed cohort of ARDS patients. By validating these biomarkers, the study seeks to develop a therapeutic algorithm to identify patients at high risk for barotrauma, ultimately improving management strategies for these individuals.

Why it matters

Potential benefit: If successful, this study could lead to better risk stratification and management of ARDS patients, potentially reducing mortality associated with barotrauma.

How similar studies have gone: Other studies have shown success in using imaging biomarkers for risk assessment in ARDS, but the specific application of the Macklin effect in this context is novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Clinical and radiological signs of ARDS, according to Berlin criteria \[14\], requiring ICU admission;
* Obtain duly signed informed consent.

Exclusion Criteria:

* Poor quality imaging (because of motion/respiratory artefacts).

Where it's running

  • Ospedale Mater Domini
    Catanzaro, Calabria, Italy
    Recruiting
  • IRCCS San Raffaele Scientific Institute
    Milan, Mi, Italy
    Recruiting

Study contacts

Similar studies

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

  • Exploring biomarkers and lung damage in ARDS patients

    This study is trying to see if certain signs in the lungs and blood can help identify ARDS patients, especially those with COVID-19, who are at risk of lung damage from treatment, so that doctors can better manage their care.

    Recruiting Università Vita-Salute San Raffaele · Cagliari and 3 other locations · NCT06001645

  • Full-Course ECMO Pathway for Moderate-to-Severe ARDS

    This study tests a standardized, full-course ECMO management pathway to see if it improves care for adults with moderate-to-severe ARDS treated with VV-ECMO in real-world Chinese centers.

    Recruiting at 15 sites Southeast University, China · Beijing and 38 other locations · NCT07726953

  • Height measurement methods to guide ventilator settings in ARDS

    We’re testing whether more precise height measurements change how researchers set lung-protective tidal volumes in adults with ARDS who are on a ventilator.

    Recruiting Centre Hospitalier Universitaire, Amiens · Amiens · NCT07595926

  • Corticosteroids for a hyperinflammatory state in critical illness

    This trial tests whether methylprednisolone helps improve organ function and survival in adults with sepsis or ARDS who show a hyperinflammatory profile.

    Recruiting Phase 2 Peking Union Medical College Hospital · Beijing, Beijing Municipality · NCT07511582

  • Right‑heart function and heart–lung interaction during ARDS with mechanical ventilation

    This project will follow adults with ARDS on mechanical ventilation to see how positive‑pressure breathing affects the right heart over time and how that relates to circulation.

    Recruiting Bicetre Hospital · Le Kremlin-Bicêtre · NCT07450846

  • Umbilical‑cord mesenchymal stem cell and secretome therapy for severe ARDS

    This trial tests whether IV umbilical‑cord mesenchymal stem cells, alone or with secretome, help adults with severe ARDS recover lung function and reduce inflammation.

    Recruiting Phase 1/2 PT. Prodia Stem Cell Indonesia · Jakarta Pusat, DKI Jakarta · NCT07439848

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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.