[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100516666":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":31,"centralContacts":44,"locations":50,"responsibleParty":83,"collaborators":85,"id":91,"slug":31,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":94,"acronym":31,"eligibilityCriteria":95,"healthyVolunteers":92,"sex":96,"minAge":97,"maxAge":31,"enrollmentInfo":98,"targetDuration":31,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":108,"overallStatus":53,"whyStopped":31,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Fisher and Paykel Healthcare","INDUSTRY",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Single-limb non-invasive ventilation with expiratory washout","EXPERIMENTAL","In a random order, 30 minute period of non-invasive ventilation using the investigational mask, a vented full-face mask with expiratory washout",[13],"Device: Investigational full-face mask with expiratory washout",{"label":15,"type":16,"description":17,"interventionNames":18},"Single-limb non-invasive ventilation","ACTIVE_COMPARATOR","In a random order, 30 minute period of non-invasive ventilation with a conventional vented full-face mask (RT077 or equivalent)",[19],"Device: Conventional full-face mask - single-limb",{"label":21,"type":16,"description":22,"interventionNames":23},"Dual-limb non-invasive ventilation","In a random order, 30 minute period of non-invasive ventilation with a conventional vented full-face mask (RT076 or equivalent)",[24],"Device: Conventional full-face mask - dual-limb",[26,32,38],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DEVICE","Investigational full-face mask with expiratory washout","With cross-over in randomized order, mask worn for 30 minutes with prescribed single-limb non-invasive ventilation",[9],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"Conventional full-face mask - single-limb","With cross-over in randomized order, conventional mask such as RT077, worn for 30 minutes with prescribed single-limb non-invasive ventilation",[15],[37],"RT077",{"type":27,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"Conventional full-face mask - dual-limb","With cross-over in randomized order, conventional mask such as RT076, worn for 30 minutes with prescribed dual-limb non-invasive ventilation",[21],[43],"RT076",[45],{"name":46,"role":47,"phone":48,"phoneExt":31,"email":49},"James Miller","CONTACT","+64273032944","jamie.miller@fphcare.co.nz",[51,69],{"facility":52,"status":53,"city":54,"state":55,"zip":56,"country":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Centre hospitalier de l'Université de Montréal (CHUM)","RECRUITING","Montreal","Quebec","20094","Canada",{"type":59,"coordinates":60},"Point",[61,62],-73.58781,45.50884,{"lat":62,"lon":61},[65],{"name":66,"role":47,"phone":67,"phoneExt":31,"email":68},"Dr. Charbonney","514 890-8000","emmanuel.charbonney@umontreal.ca",{"facility":70,"status":53,"city":71,"state":55,"zip":72,"country":57,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)","Québec","2712",{"type":59,"coordinates":74},[75,76],-71.21454,46.81228,{"lat":76,"lon":75},[79],{"name":80,"role":47,"phone":81,"phoneExt":31,"email":82},"Dr. Lellouche","418-656-8711","francois.lellouche@criucpq.ulaval.ca",{"type":84,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[86,89],{"name":87,"class":88},"Institut universitaire de cardiologie et de pneumologie de Québec, University Laval","OTHER",{"name":90,"class":88},"Centre hospitalier de l'Université de Montréal (CHUM)","100516666",false,"NCT06007495","Pilot Physiological Evaluation of an Investigational Mask with Expiratory Washout.","Inclusion Criteria:\n\n* No indication of intubation upon evaluation by physician in the next 2 hours\n* Fits the investigational mask\n\nSpecific for hypercapnic patients 1 of the following criteria\n\n* Patients hospitalized with acute respiratory failure (ARF) stabilized and tolerating NIV or;\n* Patient admitted to hospital with ARF with one criteria for NIV among the following:\n\n  * Acute hypercapnic respiratory failure with hypercapnia and acidosis (Partial pressure of arterial carbon dioxide (PaCO2) \\> 45 millimeters of mercury (mmHg) and pH \\\u003C 7.38) or\n  * Post-extubation period within 48 hours, in patients with high risk of re-intubation\n\nSpecific for hypoxemic patients\n\n1 of the following criteria\n\n* Hypoxemic respiratory failure without hypercapnia requiring nasal high flow or;\n* Hypoxemic respiratory failure without hypercapnia requiring NIV or;\n* Conventional oxygen therapy (COT) \\> 6 liters per minute (L\u002Fmin) with peripheral oxygen saturation (SpO2) \\\u003C 92%\n\nExclusion Criteria:\n\n* Refusal to participate in the study\n* Inability to provide informed consent\n* Infectious isolation\n* Facial deformity, burns or morphology that prevents adequate mask placement\n* Claustrophobia\n* Nausea\n* Presence of nasogastric tube\n* Pneumothorax\n* Confusion or loss of consciousness\n* Severe upper gastro-intestinal bleeding\n* Any other condition, which at the investigators discretion, is believed may present a safety risk or impact the feasibility of the study or study results","ALL","18 Years",{"count":99,"type":100},32,"ESTIMATED","INTERVENTIONAL",[103],"NA","The goal of this pilot randomized cross-over study is to compare the effect of a full-face mask with expiratory washout to a conventional full face mask on non-invasive ventilation (NIV) in patients with acute hypercapnic, and acute hypoxemic, respiratory failure. The main questions it aims to answer are:\n\n* Does a mask with expiratory washout improve minute ventilation in patients using non-invasive ventilation compared with a conventional single-limb NIV mask\n* How does a mask with expiratory washout affect respiratory variables compared with a dual-limb NIV mask.\n\nParticipants already prescribed NIV will undergo 3 arms of the investigation in a randomized order:\n\n* Single-limb NIV with investigation mask (with expiratory washout)\n* Single-limb NIV with conventional mask\n* Dual-limb NIV with conventional mask",[106,107],"Acute Hypercapnic Respiratory Failure","Acute Hypoxemic Respiratory Failure",[109],"Non-invasive Ventilation","2025-03-12",{"date":112,"type":113},"2025-03-14","ACTUAL",{"date":115,"type":113},"2024-05-06",{"date":117,"type":100},"2025-12",{"name":5,"class":6},2]