[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597989":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":26,"responsibleParty":31,"collaborators":35,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":41,"sex":47,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":26,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":26,"overallStatus":61,"whyStopped":26,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":26},{"fullName":5,"class":6},"National University Hospital, Singapore","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention","EXPERIMENTAL","In the HVNI group, patients will be given oxygen therapy via the Vapotherm high velocity therapy (HVT) 2.0 (Vapotherm, Inc, Exeter, NH) using a small-bore cannula, with a flow rate of up to 45 L\u002Fmin, starting temperature of 37oC and FiO2 of up to 1.0. Adjustments in flow, temperature and FiO2 will be up to the attending physician's discretion to alleviate respiratory distress and optimize comfort.",[13],"Device: Vapotherm high velocity therapy (HVT) 2.0 (Vapotherm, Inc, Exeter, NH)",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","ACTIVE_COMPARATOR","For the NIPPV group, ventilation will be performed with the Respironics Vision V60 (Philips Healthcare, Murrysville, PA) using an oronasal mask of appropriate size, with FiO2 (up to 1.0), inspiratory (IPAP 12 to 20 cmH2O) and expiratory (EPAP 5 to 10 cm H2O) pressures titrated to alleviate patient's respiratory distress.",[19],"Device: Respironics Vision V60",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Vapotherm high velocity therapy (HVT) 2.0 (Vapotherm, Inc, Exeter, NH)","Oxygen therapy will be given via the Vapotherm high velocity therapy (HVT) 2.0 (Vapotherm, Inc, Exeter, NH) using a small-bore cannula, with a flow rate of up to 45 L\u002Fmin, starting temperature of 37oC and FiO2 of up to 1.0.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Respironics Vision V60","Ventilation will be performed with the Respironics Vision V60 (Philips Healthcare, Murrysville, PA) using an oronasal mask of appropriate size, with FiO2 (up to 1.0), inspiratory (IPAP 12 to 20 cmH2O) and expiratory (EPAP 5 to 10 cm H2O) pressures titrated to alleviate patient's respiratory distress.",[15],{"type":32,"investigatorFullName":33,"investigatorTitle":34,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Mui Teng Chua","Asst Prof Mui Teng Chua",[36],{"name":37,"class":38},"Vapotherm, Inc.","INDUSTRY","100597989","hvni-vs-nippv-in-type-2-respiratory-failure-100597989",false,"NCT07065656","HVNI vs NIPPV in Type 2 Respiratory Failure","Study of High-velocity Nasal Insufflation Versus Non-invasive Positive Pressure Ventilation for Emergency Type 2 Respiratory Failure: a Non-inferiority Randomized Controlled Trial (The SHINE Trial)","SHINE","Inclusion Criteria:\n\n* adult patients aged 21 years and above, who require NIPPV for T2RF due to any cause in the Emergency Medicine Department of the National University Hospital\n\nExclusion Criteria:\n\n* patients with \"do-not-resuscitate\" orders that include NO non-invasive ventilation use \\[patients with max NIV status will still be included\\]\n* clinical suspicion or confirmed diagnosis of base of skull fractures or severe facial trauma that precludes NIPPV or nasal cannula placement\n* vulnerable patient populations (e.g., pregnant women, prisoners)\n* patients who refused consent\n* hemodynamic instability (e.g., hypotension requiring immediate resuscitation), cardiac or respiratory arrest\n* patients who require emergency intubation","ALL","21 Years","99 Years",{"count":51,"type":52},84,"ESTIMATED","INTERVENTIONAL",[55],"NA","The purpose of this study is to determine if high velocity nasal insufflation (HVNI) is comparable to non-invasive positive pressure ventilation (NIPPV) in treatment of emergency patients with acute respiratory acidosis. In our non-inferiority trial, we hypothesize that HVNI is inferior to NIPPV in reducing PaCO2 in type 2 respiratory failure (T2RF) due to any cause by a pre-specified non-inferiority margin of 4.3% decrease in PaCO2 levels after 30 minutes of treatment. The primary aim is to evaluate if HVNI is non-inferior to NIPPV in reducing PaCO2 levels in patients with T2RF from any cause. Eligible patients will be randomized to HVNI (intervention) or NIPPV (control).",[58,59,60],"Respiratory Failure","Hypoxia","Hypercapnia","NOT_YET_RECRUITING","2025-07-03",{"date":64,"type":65},"2025-07-15","ACTUAL",{"date":67,"type":52},"2025-11-01",{"date":69,"type":52},"2027-12-31",{"name":5,"class":6}]