Imaging Biomarkers to Stratify the Risk of Barotrauma in ARDS
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversità Vita-Salute San Raffaele
About this trial
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
This trial does not accept healthy volunteersQualifiers
Clinical and radiological signs of ARDS, according to Berlin criteria [14], requiring ICU admission;
Obtain duly signed informed consent.
Disqualifiers
Poor quality imaging (because of motion/respiratory artefacts).
Trial population
Patients with ARDS clinical suspicion or diagnosis will be enrolled; specifically, these patients will be admitted at intensive care unit. All patients enrolled in the prospective cohort will follow their normal course of diagnosis/treatment without any further requirements for the scope of this study other than those provided in the normal management of patients with this condition. Furthermore, any decision regarding drug or procedure will be made by the physician based on her/his clinical judgment in the context of clinical practice, independently from the decision to include the patient in this study. No follow-up medical and/or imaging examinations/laboratory analysis after hospital discharge are needed by the present study design.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Chest Computed Tomography Scan per normal clinical practice
Diagnostic testNormal Clinical practice
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Rate of clinically relevant barotrauma
Barotrauma is diagnosed only in the case of clear radiological evidence (free air at chest X-ray and/or chest CT scan). When a "central" (non-alveolar) cause of barotrauma (tracheal fissure, esophageal rupture) is suspected, endoscopy will be performed. Patients with barotrauma occurring within twelve hours from a chest interventional procedure (e.g. drains placement, central venous catheters insertion) will be excluded.
Time frame
30 days or until hospital discharge. Specifically, from date of basal CT scan until the date of first radiologically documented barotrauma.Sponsors and contacts
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Source ClinicalTrials.gov