NCT06001645 Laboratory Biomarkers and Pulmonary Interstitial Emphysema in ARDS (PIE-ARDS)
| NCT ID | NCT06001645 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Università Vita-Salute San Raffaele |
| Condition | Acute Respiratory Distress Syndrome |
| Study Type | OBSERVATIONAL |
| Enrollment | 110 participants |
| Start Date | 2023-11-27 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 110 participants in total. It began in 2023-11-27 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
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).
Frequently Asked Questions
Who can join the NCT06001645 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Respiratory Distress Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06001645 currently recruiting?
Yes, NCT06001645 is actively recruiting participants. Visit ClinicalTrials.gov or contact Università Vita-Salute San Raffaele to inquire about joining.
Where is the NCT06001645 trial being conducted?
This trial is being conducted at Cagliari, Italy, Milan, Italy, Pisa, Italy, Potenza, Italy.
Who is sponsoring the NCT06001645 clinical trial?
NCT06001645 is sponsored by Università Vita-Salute San Raffaele. The trial plans to enroll 110 participants.