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Study identifier: NCT05816954 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Imaging Biomarkers to Stratify the Risk of Barotrauma in ARDS

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

PhaseN/A
Planned participants100
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

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

Talk to the study team

Diego Palumbo, MD  ·  +39022643  ·  palumbo.diego@hsr.it

Alessandro Belletti, MD  ·  +39022643  ·  belletti.alessandro@hsr.it

Always discuss trial participation with your own doctor first.

Locations (2)

Ospedale Mater DominiCatanzaro, Calabria, ItalyRecruiting
IRCCS San Raffaele Scientific InstituteMilan, MI, ItalyRecruiting

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Source record: clinicaltrials.gov/study/NCT05816954