[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100516217":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":10,"centralContacts":10,"locations":25,"responsibleParty":86,"collaborators":10,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":91,"sex":97,"minAge":98,"maxAge":10,"enrollmentInfo":99,"targetDuration":10,"studyType":102,"phases":10,"briefSummary":103,"conditions":104,"keywords":106,"overallStatus":44,"whyStopped":10,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Università Vita-Salute San Raffaele","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Acute Respiratory Distress Syndrome",null,"Patients with ARDS requiring or not requiring invasive ventilation",[13,14],"Diagnostic Test: Blood and bronchoalveolar fluid collection and analysis","Diagnostic Test: Chest CT scan",[16,21],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":10},"DIAGNOSTIC_TEST","Blood and bronchoalveolar fluid collection and analysis","Blood and bronchoalveolar lavage fluid will be collected within 12 hours after intubation. Blood samples will be centrifuged, and the serum immediately stored at less than 70° C. The following biomarkers will be analysed in the serum and bronchoalveolar lavage fluid: Interleukin-8 (IL-8), Interleukin (IL)-6, IL-1Ra, IL-18, interferon (IFN ), Angiopoietin-2 (Ang-2), Tumour Necrosis Factor receptor-1 (TNFr1), Plasminogen Activator Inhibitor-1(PAI-1), Receptor for Advanced Glycation Endproducts (RAGE), Intercellular adhesion molecule-1 (ICAM-1), Surfactant Protein D (SPD), protein C, Von Willebrand Factor (VWF), CXCL10\u002FCXCR3, and metalloproteases (MMP9, MMP10). Blood samples obtained from the patients will be placed in specimen tubes containing heparin, centrifuged at 1500 G for 10 minutes, and then the plasma will be aspirated and stored at -70° C. Bronchoalveolar lavage fluid will be centrifuged at 1500 G for 10 minutes to remove cellular contents and stored at -70° C.",[9],{"type":17,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"Chest CT scan","Computed Tomography Scan per normal clinical practice",[9],[26,42,64,75],{"facility":27,"status":28,"city":29,"state":10,"zip":10,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":38},"A.O.U. di Cagliari","NOT_YET_RECRUITING","Cagliari","Italy","IT",{"type":33,"coordinates":34},"Point",[35,36],9.11917,39.23054,{"lat":36,"lon":35},[39],{"name":40,"role":41,"phone":10,"phoneExt":10,"email":10},"Gabriele Finco, MD","CONTACT",{"facility":43,"status":44,"city":45,"state":10,"zip":46,"country":30,"countryCode":31,"cosmosGeoPoint":47,"geoPoint":51,"contacts":52},"IRCCS San Raffaele Scientific Institute","RECRUITING","Milan","20132",{"type":33,"coordinates":48},[49,50],9.18951,45.46427,{"lat":50,"lon":49},[53,58,61],{"name":54,"role":41,"phone":55,"phoneExt":56,"email":57},"Diego Palumbo, MD","0039022643","6151","palumbo.diego@hsr.it",{"name":59,"role":41,"phone":55,"phoneExt":56,"email":60},"Alessandro Belletti, MD","belletti.alessandro@hsr.it",{"name":62,"role":63,"phone":10,"phoneExt":10,"email":10},"Michele De Bonis, MD","PRINCIPAL_INVESTIGATOR",{"facility":65,"status":28,"city":66,"state":10,"zip":10,"country":30,"countryCode":31,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"A.O.U. Pisana","Pisa",{"type":33,"coordinates":68},[69,70],10.4036,43.70853,{"lat":70,"lon":69},[73],{"name":74,"role":41,"phone":10,"phoneExt":10,"email":10},"Fabio Guarracino, MD",{"facility":76,"status":28,"city":77,"state":10,"zip":10,"country":30,"countryCode":31,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Ospedale San Carlo","Potenza",{"type":33,"coordinates":79},[80,81],15.80794,40.64175,{"lat":81,"lon":80},[84],{"name":85,"role":41,"phone":10,"phoneExt":10,"email":10},"Gianluca Paternoster, MD",{"type":63,"investigatorFullName":87,"investigatorTitle":88,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Giovanni Landoni","Full Professor","100516217","laboratory-biomarkers-and-pulmonary-interstitial-emphysema-in-ards-pie-ards-100516217",false,"NCT06001645","Laboratory Biomarkers and Pulmonary Interstitial Emphysema in ARDS (PIE-ARDS)","Pulmonary Interstitial Emphysema (Macklin Effect), Quantitative Imaging Analysis and CytoKine Profiling to Predict Lung Frailty IN ARDS","PIE-ARDS","Inclusion Criteria:\n\n* Clinical and radiological signs of ARDS, according to Berlin criteria, requiring ICU admission;\n* Obtain duly signed informed consent\n* Availability of at least one chest CT scan during hospital stay\n\nExclusion Criteria:\n\n• Poor quality imaging (because of motion\u002Frespiratory artefacts).","ALL","18 Years",{"count":100,"type":101},110,"ESTIMATED","OBSERVATIONAL","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\n\n. 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",[9,105],"Barotrauma",[9,107,108,109,110,111],"Mechanical Ventilation","Intensive Care","Respiratory Failure","Pneumothorax","Macklin effect","2025-08-06",{"date":114,"type":115},"2025-08-12","ACTUAL",{"date":117,"type":115},"2023-11-27",{"date":119,"type":101},"2027-07",{"name":5,"class":6},4]