What this means
This is a trial sign-up for a study that has not reported results yet. It plans to test whether a scan sign, the Macklin effect, predicts air leaks in the lungs.
Plain-English summary written by an AI model from the registry listing.
- Status
- Recruiting
- Who can join
- Ages 18 and over
- Where
- 4 sites
The science
- Registered title
- Laboratory Biomarkers and Pulmonary Interstitial Emphysema in ARDS (PIE-ARDS)
- Trial ID
- NCT06001645 ↗
- Phase
- Not applicable
- Study type
- observational
- Conditions
- Acute Respiratory Distress Syndrome, Barotrauma
- What is tested
- Blood and bronchoalveolar fluid collection and analysis, Chest CT scan
- Sponsor
- Università Vita-Salute San Raffaele
- Ages
- 18 Years to no maximum
- Dates
- First posted Aug 21, 2023 · updated Aug 12, 2025
Registry summary
Barotrauma (pneumothorax, pneumomediastinum) is a well-described complication of Acute Respiratory Distress Syndrome (ARDS), especially in patients with coronavirus disease 2019 (COVID-19) (16.1% in COVID-19, and about 6% in non-COVID-19 ARDS). Macklin effect was recently discovered by our group as an accurate radiological predictor of barotrauma in COVID-19 ARDS; the Investigators also found that density histograms automatically extracted from chest CT images provide a reliable insight into lung composition
. Since lung frailty is a major issue also in non-COVID-19 ARDS, the Investigators want to confirm the predictive role of Macklin effect also in this setting. In addition, the Investigators aim to explore inflammatory profiling to decipher different biological aspects of the same clinical issue. Finally, the Investigators want to develop a specific management algorithm for patients diagnosed, according to our findings, with a specific ARDS sub phenotype characterized by increased lung frailty
Sites (4)
- A.O.U. di Cagliari, Cagliari, Italy
- IRCCS San Raffaele Scientific Institute, Milan, Italy
- A.O.U. Pisana, Pisa, Italy
- Ospedale San Carlo, Potenza, Italy