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Study identifier: NCT06001645 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Laboratory Biomarkers and Pulmonary Interstitial Emphysema in ARDS (PIE-ARDS)

Condition: Acute Respiratory Distress Syndrome · Barotrauma  ·  Sponsor: Università Vita-Salute San Raffaele

PhaseN/A
Planned participants110
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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

This description comes directly from the study's public registry record.

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Contact details are listed per location below or on the registry record.

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Locations (4)

A.O.U. di CagliariCagliari, ItalyNot Yet Recruiting
IRCCS San Raffaele Scientific InstituteMilan, ItalyRecruiting
A.O.U. PisanaPisa, ItalyNot Yet Recruiting
Ospedale San CarloPotenza, ItalyNot Yet Recruiting

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Source record: clinicaltrials.gov/study/NCT06001645