[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100588324":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":26,"responsibleParty":31,"collaborators":26,"id":33,"slug":34,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":37,"acronym":26,"eligibilityCriteria":38,"healthyVolunteers":35,"sex":39,"minAge":40,"maxAge":41,"enrollmentInfo":42,"targetDuration":26,"studyType":45,"phases":46,"briefSummary":48,"conditions":49,"keywords":51,"overallStatus":55,"whyStopped":26,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":26},{"fullName":5,"class":6},"Fisher and Paykel Healthcare","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Visairo","ACTIVE_COMPARATOR","Visairo is a commercially available sub nasal oronasal mask that has a similar design as the interventional OptiNIV Dual Mask",[13],"Other: non-invasive ventilation",{"label":15,"type":16,"description":17,"interventionNames":18},"OptiNIV Dual","EXPERIMENTAL","Like the commercially available OptiNIV mask, this mask provides NIV with airway washout but now for dual limb ventilators.",[19],"Other: Non-invasive ventilation mask with airway washout",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"OTHER","Non-invasive ventilation mask with airway washout","Non-invasive ventilation mask with airway washout for dual limb ventilators",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"non-invasive ventilation","standard state of the art non-invasive ventilation",[9],{"type":32,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100588324","niv-with-airway-washout-for-dual-limb-ventilation-improvement-in-minute-ventilation-100588324",false,"NCT06939920","NIV With Airway Washout for Dual Limb Ventilation: Improvement in Minute Ventilation","Inclusion Criteria:\n\n* Adults admitted to the ICU prescribed NIV and stable\n* Able to receive therapy on a sub-nasal (under-the-nose) mask\n* Are 18 years old or older\n\nExclusion Criteria:\n\n* Contraindicated for NIV\n* NIV is likely to fail and\u002For intubation be required, at the medical staff's discretion\n* Bilevel pressure of ≥ 30 cmH2O required\n* Do not fit the investigational mask or the standard mask\n* Pregnancy (tested under standard care)\n* Unable to tolerate NIV for the duration of the investigation\n* Agitated\n* Unable to understand the consent process","ALL","18 Years","90 Years",{"count":43,"type":44},20,"ESTIMATED","INTERVENTIONAL",[47],"NA","This is a prospective, non-randomized, non-blinded, crossover feasibility investigation to assess the safety, usability, and efficacy of the investigational mask in the hospital environment. Eligible patients that are stable in NIV and able to give informed consent will be approached and if they consent the patient will be included in the study. If potential participants decline, normal hospital care will be continued. The enrolled participant will receive NIV on the commercially available Visairo mask for one hour during which their ventilatory parameters will be logged. Then the participant will be switched to the investigational mask for another hour. The ventilator data will be collected for these two hours. At the end of the intervention the participant will be reverted to their original mask. The medical staff will be asked to fill out the case report form pertaining to the function and usability of the investigational mask compared to the conventional mask.",[50],"Respiratory Failure Requiring Non Invasive Ventilation",[52,53,54],"Non-invasive ventilation","OptiNIV","Airway washout","NOT_YET_RECRUITING","2025-05-19",{"date":58,"type":59},"2025-05-22","ACTUAL",{"date":61,"type":44},"2025-07-01",{"date":63,"type":44},"2026-07-01",{"name":5,"class":6}]