Imaging Biomarkers to Stratify the Risk of Barotrauma in ARDS

Recruiting now

Conditions studied: Acute Respiratory Distress Syndrome, Barotrauma

In brief

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.

Key facts

Study ID: NCT05816954
Run by: Università Vita-Salute San Raffaele
People needed: 100
Starts: 2023-08-30
Expected to finish: 2027-07-31
Last updated by the study team: 2025-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Clinical and radiological signs of ARDS, according to Berlin criteria [14], requiring ICU admission;
Obtain duly signed informed consent.

You may not qualify if…

Poor quality imaging (because of motion/respiratory artefacts).

Where it is running

Ospedale Mater Domini — Catanzaro, Calabria, Italy (enrolling)
IRCCS San Raffaele Scientific Institute — Milan, MI, Italy (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.