Imaging Biomarkers to Stratify the Risk of Barotrauma in ARDS

Condition(s) studied

Investigational drug(s) / intervention(s)

Chest Computed Tomography Scan per normal clinical practice: Normal Clinical practice

Study 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.

Eligibility

Primary outcome measure(s)

• Rate of clinically relevant barotrauma — 30 days or until hospital discharge. Specifically, from date of basal CT scan until the date of first radiologically documented barotrauma.
  Barotrauma is diagnosed only in the case of clear radiological evidence (free air at chest X-ray and/or chest CT scan). When a "central" (non-alveolar) cause of barotrauma (tracheal fissure, esophageal rupture) is suspected, endoscopy will be performed. Patients with barotrauma occurring within twelve hours from a chest interventional procedure (e.g. drains placement, central venous catheters insertion) will be excluded.

Trial sites (2)

More Università Vita-Salute San Raffaele trials in Italy

Other trials for the same condition