[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100553276":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":31,"centralContacts":36,"locations":43,"responsibleParty":82,"collaborators":48,"id":84,"slug":48,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":85,"sex":91,"minAge":92,"maxAge":48,"enrollmentInfo":93,"targetDuration":48,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":48,"overallStatus":46,"whyStopped":48,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"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",[44,58],{"facility":45,"status":46,"city":47,"state":48,"zip":48,"country":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"General intensive care unit, Fondazione Policlinico A. Gemelli IRCCS","RECRUITING","Roma",null,"Italy",{"type":51,"coordinates":52},"Point",[53,54],11.10642,44.99364,{"lat":54,"lon":53},[57],{"name":38,"role":39,"phone":40,"phoneExt":41,"email":42},{"facility":59,"status":46,"city":60,"state":48,"zip":48,"country":49,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"Fondazione Policlinico Universitaro A. Gemelli IRCCS","Rome",{"type":51,"coordinates":62},[63,64],12.51133,41.89193,{"lat":64,"lon":63},[67,68,70,72,74,76,78,80],{"name":38,"role":39,"phone":48,"phoneExt":48,"email":48},{"name":33,"role":69,"phone":48,"phoneExt":48,"email":48},"SUB_INVESTIGATOR",{"name":71,"role":69,"phone":48,"phoneExt":48,"email":48},"Antonio M Dell'Anna, MD",{"name":73,"role":69,"phone":48,"phoneExt":48,"email":48},"Filippo Bongiovanni, MD",{"name":75,"role":69,"phone":48,"phoneExt":48,"email":48},"Giuseppe Bello, MD",{"name":77,"role":69,"phone":48,"phoneExt":48,"email":48},"Tommaso Rosà, MD",{"name":79,"role":69,"phone":48,"phoneExt":48,"email":48},"Luca S Menga, MD",{"name":81,"role":69,"phone":48,"phoneExt":48,"email":48},"Alessandro Cardu, MD",{"type":83,"investigatorFullName":48,"investigatorTitle":48,"investigatorAffiliation":48,"oldNameTitle":48,"oldOrganization":48},"SPONSOR","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":94,"type":95},20,"ESTIMATED","INTERVENTIONAL",[98],"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",[101],"Respiratory Insufficiency","2025-09-29",{"date":104,"type":105},"2025-09-30","ACTUAL",{"date":107,"type":105},"2024-11-15",{"date":109,"type":95},"2026-10-01",{"name":5,"class":6},2]