Exploring biomarkers and lung damage in ARDS patients
Pulmonary Interstitial Emphysema (Macklin Effect), Quantitative Imaging Analysis and CytoKine Profiling to Predict Lung Frailty IN ARDS
Università Vita-Salute San Raffaele · NCT06001645
This study is trying to see if certain signs in the lungs and blood can help identify ARDS patients, especially those with COVID-19, who are at risk of lung damage from treatment, so that doctors can better manage their care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Università Vita-Salute San Raffaele (other) |
| Locations | 4 sites (Cagliari and 3 other locations) |
| Trial ID | NCT06001645 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the occurrence of barotrauma in patients with Acute Respiratory Distress Syndrome (ARDS), particularly focusing on those with COVID-19. It aims to validate the Macklin effect as a predictor of barotrauma and to analyze inflammatory profiles through blood and bronchoalveolar fluid collection. The study will also utilize chest CT scans to assess lung composition and develop a management algorithm tailored for ARDS patients at high risk of barotrauma. By identifying high-risk features early, the study seeks to improve individualized patient management.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with ARDS who meet the Berlin criteria and require ICU admission.
Not a fit: Patients with poor quality imaging due to motion or respiratory artifacts may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for ARDS patients, potentially reducing the incidence of barotrauma and associated mortality.
How similar studies have performed: While the Macklin effect has been identified in COVID-19 ARDS, this study aims to confirm its predictive role in non-COVID-19 ARDS, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Cagliari and 3 other locations
- A.O.U. di Cagliari — Cagliari, Italy (NOT_YET_RECRUITING)
- IRCCS San Raffaele Scientific Institute — Milan, Italy (RECRUITING)
- A.O.U. Pisana — Pisa, Italy (NOT_YET_RECRUITING)
- Ospedale San Carlo — Potenza, Italy (NOT_YET_RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute Respiratory Distress Syndrome, Barotrauma, Mechanical Ventilation, Intensive Care, Respiratory Failure, Pneumothorax, Macklin effect