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RECRUITING
NCT05816954

Imaging Biomarkers to Stratify the Risk of Barotrauma in ARDS

Sponsor: Università Vita-Salute San Raffaele

View on ClinicalTrials.gov

Summary

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.

Official title: Artificial Intelligence-based Identification of Imaging Biomarkers of Lung FRAILty in Patients With Acute Respiratory Distress Syndrome.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2023-08-30

Completion Date

2027-07-31

Last Updated

2025-08-06

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Chest Computed Tomography Scan per normal clinical practice

Normal Clinical practice

Locations (2)

Ospedale Mater Domini

Catanzaro, Calabria, Italy

IRCCS San Raffaele Scientific Institute

Milan, MI, Italy