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

Recruitingn/aAges 18 Years - anyAllUniversità Vita-Salute San Raffaele
NCT06001645 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * Clinical and radiological signs of ARDS, according to Berlin criteria, requiring ICU admission; * Obtain duly signed informed consent * Availability of at least one chest CT scan during hospital stay Exclusion Criteria: • Poor quality imaging (because of motion/respiratory artefacts).
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What it tests

  • Blood and bronchoalveolar fluid collection and analysis
  • Chest CT scan
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Where

4 sites
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
🤝 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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