[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630217":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":18,"responsibleParty":31,"collaborators":33,"id":36,"slug":37,"hasResults":38,"nctId":39,"briefTitle":40,"officialTitle":41,"acronym":18,"eligibilityCriteria":42,"healthyVolunteers":38,"sex":43,"minAge":44,"maxAge":18,"enrollmentInfo":45,"targetDuration":18,"studyType":48,"phases":49,"briefSummary":51,"conditions":52,"keywords":55,"overallStatus":60,"whyStopped":18,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":18},{"fullName":5,"class":6},"Fisher and Paykel Healthcare","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Investigational Mask","EXPERIMENTAL","This is the arm with the second generation OptiNIV mask with airway washout. this new mask function very much like the commercially available OptiNIV mask but for a wider population as the maximum pressure is 40 not 30 cmH20 and on a wider variety of ventilators now also having a dual limb solution.",[13],"Other: NIV interface with airway washout",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard care","NO_INTERVENTION","The standard of care mask the participant is on when they are recruited. this is the comparator.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"OTHER","NIV interface with airway washout","This is a new design of the OptiNIV mask with airway washout that is commercially available.",[9],[26],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Senior clinical research scientist, doctorate","CONTACT","+64210624848","lotte.vandenheuij@fphcare.co.nz",{"type":32,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[34],{"name":35,"class":21},"Middlemore Hospital, New Zealand","100630217","vela-generation-ii-usability-and-performance-of-a-non-invasive-ventilation-mask-100630217",false,"NCT07484802","Vela Generation II: Usability and Performance of a Non-Invasive Ventilation Mask.","Vela Generation II: Usability and Performance of a Non-Invasive Ventilation Mask. A Prospective Self-Controlled Study.","Inclusion Criteria:\n\n* Adults that are stable on prescribed NIV\n* Able to receive NIV therapy on a sub-nasal mask\n* Are 21 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 doctor's discretion\n* CPAP or bilevel pressure of ≥ 30 cmH2O required\n* Do not fit the investigation mask or the standard mask\n* Pregnancy (tested under standard care)\n* Unable to tolerate NIV for the duration of the investigation\n* Unable to understand the consent process","ALL","21 Years",{"count":46,"type":47},60,"ESTIMATED","INTERVENTIONAL",[50],"NA","Study Overview The goal of this clinical trial is to learn whether an improved non invasive ventilation mask with airway washout can reduce how often people need to breathe and perform as well as standard NIV masks when used with different ventilators, in people receiving NIV therapy for respiratory distress or respiratory insufficiency.\n\nThe main question(s) it aims to answer are:\n\n* Does the new mask reduce breathing rate compared with a standard NIV mask?\n* Does the ventilator perform as expected when used with the new mask, including pressure delivery and leak?\n* Do clinicians and participants find the new mask fits and functions well?\n\nThree iterations of the new mask (vented, non-vented, dual limb) will be compared to standard of care to see if the mask reduces the need to breathe and performs consistently across ventilators compared with usual NIV masks.\n\n\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_ What Participants Will Do Participants will wear two different NIV masks, each for one hour, during a single study session lasting approximately 2.5 hours.\n\nParticipants will be asked to:\n\n* Wear a small, stick on carbon dioxide (CO₂) sensor on the skin.\n* Use their usual NIV mask for one hour while ventilator data are collected.\n* Switch to the investigational mask for one hour while ventilator data are collected.\n* Choose whether to return to their original mask or remain on the investigational mask after the study period.\n* Caregiver opinion on the mask will be collected.\n\nParticipants may also choose (optional):\n\n* To have three small blood samples taken (These samples are optional, and participants can still take part in the study if they decline them.)\n\n  * One when they agree to take part in the study\n  * One when the investigational mask is fitted\n  * One after wearing the investigational mask for one hour\n* To provide feedback on how the two masks felt and performed.\n\nDuring the study, researchers will collect data from the ventilator, including:\n\n* Breathing rate and depth\n* NIV pressure settings\n* Amount of air leak Research staff will also complete a short form assessing how well the mask fit and functioned. Participants will remain in the study until the investigational mask is removed.",[53,54],"Respiratory Insufficiency","Respiratory Failure",[56,57,58,59],"Airway washout","Fisher and Paykel healthcare","optiNIV","vela gen 2","NOT_YET_RECRUITING","2026-03-18",{"date":63,"type":64},"2026-03-20","ACTUAL",{"date":66,"type":47},"2026-07-01",{"date":68,"type":47},"2027-12-31",{"name":5,"class":6}]