Status:

RECRUITING

Laboratory Biomarkers and Pulmonary Interstitial Emphysema in ARDS (PIE-ARDS)

Lead Sponsor:

Università Vita-Salute San Raffaele

Conditions:

Acute Respiratory Distress Syndrome

Barotrauma

Eligibility:

All Genders

18+ years

Brief Summary

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 C...

Detailed Description

Barotrauma occurs frequently in acute respiratory distress syndrome (ARDS), and has a difficult, non-standardized management. Unfortunately, mortality rates remain high (\> 60% in COVID-19 ARDS, aroun...

Eligibility Criteria

Inclusion

  • Clinical and radiological signs of ARDS, according to Berlin criteria, requiring ICU admission;
  • Obtain duly signed informed consent
  • Availability of at least one chest CT scan during hospital stay

Exclusion

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

Key Trial Info

Start Date :

November 27 2023

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

July 1 2027

Estimated Enrollment :

110 Patients enrolled

Trial Details

Trial ID

NCT06001645

Start Date

November 27 2023

End Date

July 1 2027

Last Update

August 12 2025

Active Locations (4)

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Page 1 of 1 (4 locations)

1

A.O.U. di Cagliari

Cagliari, Italy

2

IRCCS San Raffaele Scientific Institute

Milan, Italy, 20132

3

A.O.U. Pisana

Pisa, Italy

4

Ospedale San Carlo

Potenza, Italy