Using imaging to assess risk of lung injury in ARDS patients
Artificial Intelligence-based Identification of Imaging Biomarkers of Lung FRAILty in Patients With Acute Respiratory Distress Syndrome.
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 |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Università Vita-Salute San Raffaele Academic / other |
| Locations | 2 sites (Catanzaro, Calabria and 1 other locations) |
| Trial ID | NCT05816954 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with ARDS who require ICU admission and can provide informed consent.
Not a fit: Patients with poor quality imaging due to motion or respiratory artifacts may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Catanzaro, Calabria and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.