Actively Recruiting

Age: 18Years +
All Genders
NCT05816954

Imaging Biomarkers to Stratify the Risk of Barotrauma in ARDS

Led by Università Vita-Salute San Raffaele · Updated on 2025-08-06

100

Participants Needed

2

Research Sites

204 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Imaging Biomarkers to Stratify the Risk of Barotrauma in 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
  • Obtain duly signed informed consent
Not Eligible

You will not qualify if you...

  • Poor quality imaging due to motion or respiratory artifacts

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Ospedale Mater Domini

Catanzaro, Calabria, Italy

Actively Recruiting

2

IRCCS San Raffaele Scientific Institute

Milan, MI, Italy, 20132

Actively Recruiting

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Research Team

D

Diego Palumbo, MD

CONTACT

A

Alessandro Belletti, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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