[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571150":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":35,"locations":44,"responsibleParty":82,"collaborators":86,"id":91,"slug":25,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":98,"sex":99,"minAge":100,"maxAge":25,"enrollmentInfo":101,"targetDuration":25,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":111,"overallStatus":61,"whyStopped":25,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Università Vita-Salute San Raffaele","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Healthy elderly individuals","EXPERIMENTAL","The performance and easiness to use of the device will be evaluated in patients' self-experience conditions, with elderly participants self-applying the device.",[13],"Device: Portable CPAP usability assessment",{"label":15,"type":10,"description":16,"interventionNames":17},"Patients with mild oxygenation impairment","The efficacy of the device will be assessed in patients with mild oxygenation impairment.",[18],"Device: Portable CPAP efficacy",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Portable CPAP efficacy","The device will be tested in providing a PEEP comprised between 4-7,5 cmH2O",[15],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Portable CPAP usability assessment","The device usability will be evaluated in individual's self-experience tests, i.e., in conditions where the volunteer will self-apply the device.",[9],[31],{"name":32,"affiliation":33,"role":34},"Giovanni Landoni, MD","IRCCS San Raffaele","STUDY_CHAIR",[36,41],{"name":32,"role":37,"phone":38,"phoneExt":39,"email":40},"CONTACT","+39 022643","6151","landoni.giovanni@hsr.it",{"name":42,"role":37,"phone":38,"phoneExt":39,"email":43},"Rosalba Lembo","lembo.rosalba@hsr.it",[45,60,71],{"facility":46,"status":47,"city":48,"state":49,"zip":25,"country":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Città di Lecce Hospital","NOT_YET_RECRUITING","Lecce","Apulia","Italy",{"type":52,"coordinates":53},"Point",[54,55],18.17244,40.35481,{"lat":55,"lon":54},[58],{"name":59,"role":37,"phone":25,"phoneExt":25,"email":25},"Giuseppe Santarpino, MD",{"facility":33,"status":61,"city":62,"state":25,"zip":63,"country":50,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"RECRUITING","Milan","20132",{"type":52,"coordinates":65},[66,67],9.18951,45.46427,{"lat":67,"lon":66},[70],{"name":32,"role":37,"phone":25,"phoneExt":25,"email":40},{"facility":72,"status":47,"city":73,"state":25,"zip":25,"country":50,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"Università degli studi di Verona","Verona",{"type":52,"coordinates":75},[76,77],10.9938,45.43854,{"lat":77,"lon":76},[80],{"name":81,"role":37,"phone":25,"phoneExt":25,"email":25},"Katia Donadello, MD",{"type":83,"investigatorFullName":84,"investigatorTitle":85,"investigatorAffiliation":33,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Giovanni Landoni","Director of the Research Center for Intensive Care and Anesthesiology of San Raffaele Scientific Institute",[87,89],{"name":88,"class":6},"Azienda Ospedaliera Universitaria Integrata Verona",{"name":46,"class":90},"UNKNOWN","100571150",false,"NCT06716502","A New Portable Device for Non-invasive Ventilatory Support","A New Portable Device for PRE-hospital Non-invasive VENTilatory Support in Acute Respiratory Failure","PREVENT","Arm 1\n\nInclusion Criteria:\n\n1. Age ≥65 years\n2. Clinically stable: non-hospitalized and not in acute illness\n3. no professional medical knowledge: no experience as a health care provider\n4. Ability to express informed consent as requested by the ethical committee\n\nArm 1 Exclusion Criteria: none\n\nArm 2\n\nInclusion Criteria:\n\n1. Hospitalized adult patient\n2. SpO2 of 90-93% in room air\n\nArm 2\n\nExclusion Criteria:\n\n1. Facial burns\u002Ftrauma\u002Frecent facial or upper airway surgery\n2. Vomiting\n3. Fixed upper airway obstruction\n4. Undrained pneumothorax\n5. Recent upper gastrointestinal surgery\n6. Inability to protect the airway\n7. Bowel obstruction\n8. Patient refusal",true,"ALL","65 Years",{"count":102,"type":103},50,"ESTIMATED","INTERVENTIONAL",[106],"NA","Acute respiratory failure is a medical emergency rapidly leading to death, if not timely treated. Prompt Continuous Positive Airway Pressure (CPAP) improves patient outcomes. However, pre-hospital CPAP is currently limited to healthcare providers due to the absence of easy-to-use and immediate devices specifically designed for the non-medical population.\n\nThe efficacy and usability of a new portable CPAP device will be assessed. This device is specifically designed for potential use in out-of-hospital scenarios involving acute respiratory failure. The evaluation will focus not only on the performance of the device but also on its easiness of use.",[109,110],"Healthy","Respiratory Disease",[112,113,114],"CPAP","NIV","Respiratory failure","2026-05-05",{"date":117,"type":118},"2026-05-06","ACTUAL",{"date":120,"type":118},"2025-09-17",{"date":122,"type":103},"2026-06-19",{"name":5,"class":6},3]