Actively Recruiting

Age: 18Years +
All Genders
NCT06001645

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

Led by Università Vita-Salute San Raffaele · Updated on 2025-08-12

110

Participants Needed

4

Research Sites

187 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinical and radiological signs of ARDS, according to Berlin criteria, requiring ICU admission
  • Signed informed consent obtained
  • At least one chest CT scan available during hospital stay
Not Eligible

You will not qualify if you...

  • Poor quality imaging due to motion or respiratory artifacts

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

A.O.U. di Cagliari

Cagliari, Italy

Not Yet Recruiting

2

IRCCS San Raffaele Scientific Institute

Milan, Italy, 20132

Actively Recruiting

3

A.O.U. Pisana

Pisa, Italy

Not Yet Recruiting

4

Ospedale San Carlo

Potenza, Italy

Not Yet Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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