[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100478202":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":29,"locations":39,"responsibleParty":189,"collaborators":18,"id":191,"slug":192,"hasResults":193,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":197,"eligibilityCriteria":198,"healthyVolunteers":193,"sex":199,"minAge":200,"maxAge":18,"enrollmentInfo":201,"targetDuration":18,"studyType":204,"phases":205,"briefSummary":207,"conditions":208,"keywords":18,"overallStatus":42,"whyStopped":18,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":219},{"fullName":5,"class":6},"Ottawa Hospital Research Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Extubation Advisor","EXPERIMENTAL","Wave form data from participants' spontaneous breathing trials (SBT) will be analyzed using Extubation Advisor (EA) to generate an EA report that provides clinical decision support regarding extubation.",[13],"Device: Extubation Advisor",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of Care Arm","NO_INTERVENTION","Participants will undergo SBTs as directed by clinicians. The EA device will not be used.",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":18},"DEVICE","Participants undergoing a Spontaneous Breathing Trial (SBT) to assess readiness for extubation will be connected to a portable monitor displaying ECG, capnography, and other waveforms. This monitor will also be connected to a laptop containing the Extubation Advisor (EA) software. During the SBT, relevant patient information will be entered into the EA application and the EA application will record waveform data. When the SBT is complete, the EA application will analyze the waveform and patient data to generate a score summarizing the risk of extubation failure. A report will be generated and provided to the respiratory therapist and attending physician to help determine whether to proceed with extubation or not. The clinical outcome case report form will be completed at the time of hospital discharge.",[9],[25],{"name":26,"affiliation":27,"role":28},"Karen Burns, MD PhD FRCSC","Unity Health Toronto - St. Michael's Hospital","PRINCIPAL_INVESTIGATOR",[30,36],{"name":31,"role":32,"phone":33,"phoneExt":34,"email":35},"Andrew JE Seely, MD PhD FRCSC","CONTACT","613-737-8899","74052","aseely@toh.ca",{"name":37,"role":32,"phone":18,"phoneExt":18,"email":38},"Karen Burns, MD MSc FRCPC","karen.burns@unityhealth.to",[40,58,72,82,96,110,120,133,141,155,168,181],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Royal Alexandra Hospital","RECRUITING","Edmonton","Alberta","T5H 3V9","Canada","CA",{"type":49,"coordinates":50},"Point",[51,52],-113.46871,53.55014,{"lat":52,"lon":51},[55,57],{"name":56,"role":32,"phone":18,"phoneExt":18,"email":18},"Demetrios J Kutsogiannis, MD MHS FRCPC",{"name":56,"role":28,"phone":18,"phoneExt":18,"email":18},{"facility":59,"status":42,"city":60,"state":61,"zip":62,"country":46,"countryCode":47,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"St. Boniface Hospital","Winnipeg","Manitoba","R2H 2A6",{"type":49,"coordinates":64},[65,66],-97.14704,49.8844,{"lat":66,"lon":65},[69,71],{"name":70,"role":32,"phone":18,"phoneExt":18,"email":18},"Owen Mooney, MD FRCPC",{"name":70,"role":28,"phone":18,"phoneExt":18,"email":18},{"facility":73,"status":42,"city":60,"state":61,"zip":74,"country":46,"countryCode":47,"cosmosGeoPoint":75,"geoPoint":77,"contacts":78},"Health Sciences Centre Winnipeg","R3A 1R9",{"type":49,"coordinates":76},[65,66],{"lat":66,"lon":65},[79,81],{"name":80,"role":32,"phone":18,"phoneExt":18,"email":18},"Asher Mendelson, MD PhD FRCPC",{"name":80,"role":28,"phone":18,"phoneExt":18,"email":18},{"facility":83,"status":42,"city":84,"state":85,"zip":86,"country":46,"countryCode":47,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Kingston Health Sciences Centre","Kingston","Ontario","K7L 2V7",{"type":49,"coordinates":88},[89,90],-76.48098,44.22976,{"lat":90,"lon":89},[93,95],{"name":94,"role":32,"phone":18,"phoneExt":18,"email":18},"David Maslove, MD MS FRCPC",{"name":94,"role":28,"phone":18,"phoneExt":18,"email":18},{"facility":97,"status":42,"city":98,"state":85,"zip":99,"country":46,"countryCode":47,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"The Ottawa Hospital","Ottawa","K1H 8L6",{"type":49,"coordinates":101},[102,103],-75.69812,45.41117,{"lat":103,"lon":102},[106,108],{"name":31,"role":32,"phone":33,"phoneExt":107,"email":35},"75052",{"name":109,"role":28,"phone":18,"phoneExt":18,"email":18},"Alexander Tran, MD FRCPC",{"facility":111,"status":42,"city":98,"state":85,"zip":112,"country":46,"countryCode":47,"cosmosGeoPoint":113,"geoPoint":115,"contacts":116},"Queensway Carleton Hospital","K2H 8P4",{"type":49,"coordinates":114},[102,103],{"lat":103,"lon":102},[117,119],{"name":118,"role":32,"phone":18,"phoneExt":18,"email":18},"Akshai M Iyengar, MSc MD FRCPC",{"name":118,"role":28,"phone":18,"phoneExt":18,"email":18},{"facility":121,"status":42,"city":122,"state":85,"zip":123,"country":46,"countryCode":47,"cosmosGeoPoint":124,"geoPoint":128,"contacts":129},"Sunnybrook Health Sciences Centre","Toronto","M4N 3M5",{"type":49,"coordinates":125},[126,127],-79.39864,43.70643,{"lat":127,"lon":126},[130,132],{"name":131,"role":32,"phone":18,"phoneExt":18,"email":18},"Damon Scales, MD PhD FRCPC",{"name":131,"role":28,"phone":18,"phoneExt":18,"email":18},{"facility":27,"status":42,"city":122,"state":85,"zip":134,"country":46,"countryCode":47,"cosmosGeoPoint":135,"geoPoint":137,"contacts":138},"M5B 1W8",{"type":49,"coordinates":136},[126,127],{"lat":127,"lon":126},[139,140],{"name":37,"role":32,"phone":18,"phoneExt":18,"email":38},{"name":37,"role":28,"phone":18,"phoneExt":18,"email":18},{"facility":142,"status":42,"city":143,"state":144,"zip":145,"country":46,"countryCode":47,"cosmosGeoPoint":146,"geoPoint":150,"contacts":151},"Hotel Dieu de Levis","Lévis","Quebec","G6V 3Z1",{"type":49,"coordinates":147},[148,149],-71.17793,46.80326,{"lat":149,"lon":148},[152,154],{"name":153,"role":32,"phone":18,"phoneExt":18,"email":18},"Patrick Archambault, MD FRCPC",{"name":153,"role":28,"phone":18,"phoneExt":18,"email":18},{"facility":156,"status":42,"city":157,"state":144,"zip":158,"country":46,"countryCode":47,"cosmosGeoPoint":159,"geoPoint":163,"contacts":164},"Centre hospitalier de l'Université de Montréal (CHUM)","Montreal","H2X 3E4",{"type":49,"coordinates":160},[161,162],-73.58781,45.50884,{"lat":162,"lon":161},[165,167],{"name":166,"role":32,"phone":18,"phoneExt":18,"email":18},"Emmanuel Charbonney, MD PhD",{"name":166,"role":28,"phone":18,"phoneExt":18,"email":18},{"facility":169,"status":42,"city":170,"state":144,"zip":171,"country":46,"countryCode":47,"cosmosGeoPoint":172,"geoPoint":176,"contacts":177},"Hopital de l'Enfant Jesus","Québec","G1J 1Z4",{"type":49,"coordinates":173},[174,175],-71.21454,46.81228,{"lat":175,"lon":174},[178,180],{"name":179,"role":32,"phone":18,"phoneExt":18,"email":18},"Alexis F Turgeon, MD, MSc, FRCPC",{"name":179,"role":28,"phone":18,"phoneExt":18,"email":18},{"facility":182,"status":42,"city":183,"state":144,"zip":184,"country":46,"countryCode":47,"cosmosGeoPoint":18,"geoPoint":18,"contacts":185},"Institut universitaire de cardiologie et de pneumologie de Québec","Ste-Foy","G1V 4G5",[186,188],{"name":187,"role":32,"phone":18,"phoneExt":18,"email":18},"Francois Lellouche, MD PhD FRCPC",{"name":187,"role":28,"phone":18,"phoneExt":18,"email":18},{"type":190,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100478202","liberation-from-mechanical-ventilation-using-extubation-advisor-decision-support-100478202",false,"NCT05506904","Liberation From Mechanical Ventilation Using Extubation Advisor Decision Support","Liberation From Mechanical Ventilation Using Extubation Advisor Decision Support: The Multicentre (LEADS) Pilot Trial","LEADS","Inclusion Criteria:\n\n* Critically ill adults (age≥18)\n* Invasive ventilation for \\>48 hours\n* Who are expected to undergo an initial SBT within the next 48 hours with a view to extubation as per treating MDs. As per the FAST trial, an SBT will be defined as a focused assessment on low ventilator settings \\[T-piece, continuous positive airway pressure (CPAP), or PS \\\u003C 8 cm H2O regardless of positive end-expiratory pressure (PEEP)\n\nExclusion Criteria:\n\n* Suffer from known or suspected peripheral severe myopathy or neuropathy, or limb weakness or paralysis or central (e.g., post arrest, large intracranial stroke or bleed) injury or Glasgow Coma Scale (GCS) \\\u003C 6\n* Do not wish to be re-intubated as part of their treatment goals\n* Were previously extubated during the same ICU admission\n* Have undergone 1 or more SBTs where the SBT was clearly documented in the chart and\u002For the PS was reduced to the SBT level of 8 or less during the 24 hour period prior to randomization\n* Already have a tracheostomy\n* Are moribund or expected to die.","ALL","18 Years",{"count":202,"type":203},200,"ESTIMATED","INTERVENTIONAL",[206],"NA","Timely and safe extubation in critically ill patients is vitally important as prolonged mechanical ventilation and failed attempts at extubation are associated with increased morbidity, mortality, costs, intensive care unit (ICU) stays, and a risk for aerosolization of COVID-19 to health care providers. A Spontaneous Breathing Trial (SBT) is the current standard of care to assess a patient's readiness for extubation. However, SBTs are performed in various ways and have poor ability to predict successful extubation on their own. There is an urgent need to improve and standardize extubation decision-making. In a prior multicenter study, the investigators showed that decreased respiratory rate variability during SBTs predicted extubation failure better than other predictive indices.\n\nThe Extubation Advisor (EA) tool combines clinician's assessments of extubation readiness with predictive analytics and risk mitigation strategies for individual patients. In a single centre observational study, the investigators demonstrated the ability to deliver EA reports to the bedside and acceptability of this decision-support tool to respiratory therapists (RTs) and physicians (MDs).\n\nThe investigators will conduct the Liberation from mechanical ventilation using EA Decision Support (LEADS) Pilot Trial to assess feasibility outcomes. They will include critically ill adults who are invasively ventilated for \\>48 hours and are ready to undergo an SBT.\n\nPatients in the intervention arm undergo an EA assessment and treating clinicians (RTs, MDs) will receive an EA report for each SBT conducted. The EA report will help to guide extubation decision-making. Patients in the control arm receive standard care. SBTs will be directed by clinicians.\n\nThe primary feasibility outcome will reflect the ability to recruit the desired population. The investigators will also assess the usefulness of the tool to MDs and complete an analysis of resource utilization to inform future economic analyses of cost-effectiveness. The investigators aim to recruit 1 to 2 patients\u002Fmonth\u002Fcenter.\n\nThe LEADS trial is novel and low-risk. It is the first trial to evaluate use of a bedside decision support tool to assist ICU clinicians with extubation decision-making. The LEADS pilot trial will inform the design of a future, large-scale randomized controlled trial that is expected to enhance the care delivered to critically ill patients, improve extubation outcomes, and inform extubation practice in ICUs.",[209],"Airway Extubation","2026-04-17",{"date":212,"type":213},"2026-04-22","ACTUAL",{"date":215,"type":213},"2024-04-22",{"date":217,"type":203},"2026-12-31",{"name":5,"class":6},12]