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Imaging Biomarkers to Stratify the Risk of Barotrauma in ARDS

Recruitingn/aAges 18 Years - anyAllUniversità Vita-Salute San Raffaele
NCT05816954 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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).
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What it tests

  • Chest Computed Tomography Scan per normal clinical practice
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Where

2 sites
Ospedale Mater Domini
Catanzaro, Italy
IRCCS San Raffaele Scientific Institute
Milan, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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