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Search / Trial NCT06001645

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

Launched by UNIVERSITÀ VITA-SALUTE SAN RAFFAELE · Aug 17, 2023

Trial Information

Current as of August 22, 2025

Recruiting

Keywords

Acute Respiratory Distress Syndrome Mechanical Ventilation Intensive Care Respiratory Failure Pneumothorax Macklin Effect

ClinConnect Summary

The PIE-ARDS clinical trial is studying a serious lung condition called Acute Respiratory Distress Syndrome (ARDS), which can occur in patients, especially those with COVID-19. One of the complications of ARDS is barotrauma, where the lungs can be damaged due to pressure changes. Researchers discovered a promising method called the Macklin effect that helps predict this complication using chest scans. They want to see if this method works for patients with ARDS caused by other conditions as well. The trial will also look at different markers in the body to understand the inflammation related to ARDS and aims to create a management plan for patients who show signs of weakened lungs.

To participate in this trial, you need to be between 65 and 74 years old, have clear signs of ARDS requiring admission to the Intensive Care Unit (ICU), and have a chest scan taken during your hospital stay. Participants will be asked to sign a consent form and may undergo additional assessments related to their lung condition. The trial is currently recruiting participants and is important for improving the way ARDS is treated and managed, particularly in identifying those who are more vulnerable due to lung frailty.

Gender

ALL

Eligibility criteria

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

About Università Vita Salute San Raffaele

Università Vita-Salute San Raffaele is a prestigious Italian academic institution renowned for its commitment to advancing healthcare through innovative research and education. Located in Milan, it integrates cutting-edge scientific inquiry with clinical practice, fostering interdisciplinary collaboration among healthcare professionals. The university is dedicated to improving patient outcomes and public health by conducting rigorous clinical trials that adhere to the highest ethical standards. Its focus spans various medical fields, leveraging state-of-the-art facilities and a strong network of partnerships to drive advancements in medical science and contribute to the global healthcare community.

Locations

Potenza, , Italy

Milan, , Italy

Pisa, , Italy

Cagliari, , Italy

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported