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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Università Vita-Salute San Raffaele Academic / other |
| Locations | 2 sites (Catanzaro, Calabria and 1 other locations) |
| Status | Recruiting |
| Started | August 30, 2023 |
| Main results expected | April 30, 2027 |
| Study ends | July 31, 2027 |
| Registry record updated | August 6, 2025 |
| Trial ID | NCT05816954 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
- Study coordinator: Diego Palumbo, MD
- Email: palumbo.diego@hsr.it
- Phone: +39022643
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.