What this means
Researchers plan to check whether certain lung scan signs predict air leak injury in people with severe breathing failure. This registration describes a plan, so it does not show that the scans work.
Plain-English summary written by an AI model from the registry listing.
- Status
- Recruiting
- Who can join
- Ages 18 and over
- Where
- 2 sites
The science
- Registered title
- Imaging Biomarkers to Stratify the Risk of Barotrauma in ARDS
- Trial ID
- NCT05816954 ↗
- Phase
- Not applicable
- Study type
- observational
- Conditions
- Acute Respiratory Distress Syndrome, Barotrauma
- What is tested
- Chest Computed Tomography Scan per normal clinical practice
- Sponsor
- Università Vita-Salute San Raffaele
- Ages
- 18 Years to no maximum
- Dates
- First posted Apr 18, 2023 · updated Aug 6, 2025
Registry summary
The high incidence of barotrauma in patients with COVID-19-related acute respiratory distress syndrome (ARDS) (16.1%, with a mortality rate >60%) provides rationale for considering COVID-19 ARDS a paradigm for lung frailty. The investigators recently discovered that the Macklin effect is an impressive radiological predictor of barotrauma in COVID-19 ARDS. Since lung frailty is a major issue also in non-COVID-19 ARDS (6% barotrauma, with a mortality rate of 46% ) the investigators want to confirm the importance of Macklin effect in non-COVID-19 ARDS. Using artificial intelligence-based approaches the investigators also want to identify imaging biomarkers to non-invasively assess lung frailty in a mixed cohort of COVID-19/non-COVID-19 ARDS patients. Furthermore, the investigators want to prospectively validate these biomarkers in a cohort of ARDS patients. This will provide a therapeutic algorithm for ARDS patients at high-risk for barotrauma, identifying those most likely to benefit from hyper protective strategies.
Sites (2)
- Ospedale Mater Domini, Catanzaro, Calabria, Italy
- IRCCS San Raffaele Scientific Institute, Milan, MI, Italy