Pulmonary Interstitial Emphysema (Macklin Effect), Quantitative Imaging Analysis and CytoKine Profiling to Predict Lung Frailty IN ARDS (PIE-ARDS)

NCT06001645 RECRUITING

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

Details

Lead sponsor	Università Vita-Salute San Raffaele
Status	RECRUITING
Enrolment	110
Start date	2023-11-27
Completion	2027-07

Conditions

• Acute Respiratory Distress Syndrome
• Barotrauma

Interventions

• Blood and bronchoalveolar fluid collection and analysis
• Chest CT scan

Primary outcomes

• 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). Rate of barotrauma will be compared between patients with an hyperinflammatory pattern as compared with control.

Countries

Italy