NCT05816954 Imaging Biomarkers to Stratify the Risk of Barotrauma in ARDS
| NCT ID | NCT05816954 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Università Vita-Salute San Raffaele |
| Condition | Acute Respiratory Distress Syndrome |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-08-30 |
| Primary Completion | 2027-04-30 |
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 100 participants in total. It began in 2023-08-30 with a primary completion date of 2027-04-30.
⚠ 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
The high incidence of barotrauma in patients with COVID-19-related acute respiratory distress syndrome (ARDS) (16.1%, with a mortality rate \>60%) provides rationale for considering COVID-19 ARDS a paradigm for lung frailty. The investigators recently discovered that the Macklin effect is an impressive radiological predictor of barotrauma in COVID-19 ARDS. Since lung frailty is a major issue also in non-COVID-19 ARDS (6% barotrauma, with a mortality rate of 46% ) the investigators want to confirm the importance of Macklin effect in non-COVID-19 ARDS. Using artificial intelligence-based approaches the investigators also want to identify imaging biomarkers to non-invasively assess lung frailty in a mixed cohort of COVID-19/non-COVID-19 ARDS patients. Furthermore, the investigators want to prospectively validate these biomarkers in a cohort of ARDS patients. This will provide a therapeutic algorithm for ARDS patients at high-risk for barotrauma, identifying those most likely to benefit from hyper protective strategies.
Eligibility Criteria
Inclusion Criteria: * Clinical and radiological signs of ARDS, according to Berlin criteria \[14\], requiring ICU admission; * Obtain duly signed informed consent. Exclusion Criteria: * Poor quality imaging (because of motion/respiratory artefacts).
Contact & Investigator
Giovanni Landoni, Professor
STUDY CHAIR
Università Vita-Salute San Raffaele
Frequently Asked Questions
Who can join the NCT05816954 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 NCT05816954 currently recruiting?
Yes, NCT05816954 is actively recruiting participants. Contact the research team at palumbo.diego@hsr.it for enrollment information.
Where is the NCT05816954 trial being conducted?
This trial is being conducted at Catanzaro, Italy, Milan, Italy.
Who is sponsoring the NCT05816954 clinical trial?
NCT05816954 is sponsored by Università Vita-Salute San Raffaele. The principal investigator is Giovanni Landoni, Professor at Università Vita-Salute San Raffaele. The trial plans to enroll 100 participants.