[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100553276":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":31,"centralContacts":36,"locations":43,"responsibleParty":83,"collaborators":48,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":87,"sex":93,"minAge":94,"maxAge":48,"enrollmentInfo":95,"targetDuration":48,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":48,"overallStatus":46,"whyStopped":48,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Facemask 'Nivairo'","ACTIVE_COMPARATOR","Oronasal mask for noninvasive ventilation",[13],"Device: Noninvasive ventilation",{"label":15,"type":16,"description":17,"interventionNames":18},"Bridge-free facemask 'Visairo'","EXPERIMENTAL","Bridge-free facemask for noninvasive ventilation. This Bridge-Free NIV contacts the patient's nose only on the nostrils",[13],{"label":20,"type":16,"description":21,"interventionNames":22},"Facemask 'Optiniv'","Facemask for noninvasive ventilation favoring carbon dioxide washout",[13],[24],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DEVICE","Noninvasive ventilation","Respiratory support with a facemask connected to a ventilator through a heated humidifier. Ventilator will be set in the pressure support mode.",[15,9,20],[30],"Positive-pressure ventilation",[32],{"name":33,"affiliation":34,"role":35},"Massimo Antonelli, MD","Catholic University of the Sacred Heart","STUDY_CHAIR",[37],{"name":38,"role":39,"phone":40,"phoneExt":41,"email":42},"Domenico Luca Grieco, MD","CONTACT","+39063015","4490","domenicoluca.grieco@unicatt.it",[44,59],{"facility":45,"status":46,"city":47,"state":48,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"General intensive care unit, Fondazione Policlinico A. Gemelli IRCCS","RECRUITING","Roma",null,"Italy","IT",{"type":52,"coordinates":53},"Point",[54,55],11.10642,44.99364,{"lat":55,"lon":54},[58],{"name":38,"role":39,"phone":40,"phoneExt":41,"email":42},{"facility":60,"status":46,"city":61,"state":48,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"Fondazione Policlinico Universitaro A. Gemelli IRCCS","Rome",{"type":52,"coordinates":63},[64,65],12.51133,41.89193,{"lat":65,"lon":64},[68,69,71,73,75,77,79,81],{"name":38,"role":39,"phone":48,"phoneExt":48,"email":48},{"name":33,"role":70,"phone":48,"phoneExt":48,"email":48},"SUB_INVESTIGATOR",{"name":72,"role":70,"phone":48,"phoneExt":48,"email":48},"Antonio M Dell'Anna, MD",{"name":74,"role":70,"phone":48,"phoneExt":48,"email":48},"Filippo Bongiovanni, MD",{"name":76,"role":70,"phone":48,"phoneExt":48,"email":48},"Giuseppe Bello, MD",{"name":78,"role":70,"phone":48,"phoneExt":48,"email":48},"Tommaso Rosà, MD",{"name":80,"role":70,"phone":48,"phoneExt":48,"email":48},"Luca S Menga, MD",{"name":82,"role":70,"phone":48,"phoneExt":48,"email":48},"Alessandro Cardu, MD",{"type":84,"investigatorFullName":48,"investigatorTitle":48,"investigatorAffiliation":48,"oldNameTitle":48,"oldOrganization":48},"SPONSOR","100553276","noninvasive-ventilation-facemasks-favoring-carbon-dioxide-washout-100553276",false,"NCT06483984","Noninvasive Ventilation Facemasks Favoring Carbon Dioxide Washout","Physiological Effects of Novel Noninvasive Ventilation Facemasks Favoring Carbon Dioxide Washout in Patients With Hypercapnic Respiratory Failure","MASHUP","Inclusion Criteria:\n\nAcute respiratory failure with\n\n* PaCO2 ≥ 45 mmHg;\n* Arterial pH \\\u003C 7.35;\n* Signed written informed consent\n\nExclusion Criteria:\n\n* Respiratory rate \\\u003C 12 bpm;\n* Immediate need for intubation;\n* Haemodynamic instability (Systolic blood pressure \\\u003C90 mmHg or mean arterial pressure \\\u003C65 mmHg) and\u002For lactic acidosis (lactate \\>5 mmol\u002FL) and\u002For clinically diagnosed shock;\n* Metabolic Acidosis;\n* Recent head surgery or anatomy that prevent the application of facemasks;\n* Any contraindications to oesophageal balloon insertion and\u002For electrical impedance tomography (EIT) belt placement.\n* Any contraindications to facemask noninvasive ventilation.","ALL","18 Years",{"count":96,"type":97},20,"ESTIMATED","INTERVENTIONAL",[100],"NA","The objective of this randomized cross-over trial is to assess the physiological effects of three different facemasks for noninvasive ventilation (Nivairo, Visairo, Optiniv) in patients with acute hypercapnic respiratory failure",[103],"Respiratory Insufficiency","2025-09-29",{"date":106,"type":107},"2025-09-30","ACTUAL",{"date":109,"type":107},"2024-11-15",{"date":111,"type":97},"2026-10-01",{"name":5,"class":6},2]