[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626445":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":28,"centralContacts":32,"locations":41,"responsibleParty":59,"collaborators":63,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":24,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":24,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":24,"overallStatus":44,"whyStopped":24,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Capital Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Speaking Valve Group","EXPERIMENTAL","Passy-Muir Speaking Valve",[13],"Other: Passy-Muir Speaking Valve",{"label":15,"type":16,"description":17,"interventionNames":18},"Capping Group","ACTIVE_COMPARATOR","Tracheostomy tube capping",[19],"Other: Tracheostomy tube capping",[21,25],{"type":6,"name":11,"description":22,"armGroupLabels":23,"otherNames":24},"Stepwise tolerance assessment: 0.5 hour → 4 hours. Decannulation Criteria: Continuous tolerance for 4 hours with stable vital signs, peripheral capillary oxygen saturation(SpO₂) ≥93% (on room air or low-flow oxygen), no significant respiratory distress. If patients in the Capping Group group cannot tolerate continuous catheter occlusion for 48 hours, they are transferred to the Speaking Valve group and undergo a 4-hour voice valve test starting at 0.5 hours.",[9],null,{"type":6,"name":17,"description":26,"armGroupLabels":27,"otherNames":24},"Gradual capping: 1hour → 48hours. Decannulation Criteria: Continuous tolerance for 48 hours with stable vital signs, SpO₂ ≥93% (on room air or low-flow oxygen), no significant respiratory distress.",[15],[29],{"name":30,"affiliation":5,"role":31},"Hongying Jiang","STUDY_CHAIR",[33,38],{"name":34,"role":35,"phone":36,"phoneExt":24,"email":37},"Qian Feng","CONTACT","17207122873","fengqian0263@163.com",{"name":30,"role":35,"phone":39,"phoneExt":24,"email":40},"56981555","6jhy@163.com",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Beijing Rehabilitation Hospital, Capital Medical University","RECRUITING","Beijing","Beijing Municipality","100043","China","CN",{"type":51,"coordinates":52},"Point",[53,54],116.39723,39.9075,{"lat":54,"lon":53},[57,58],{"name":34,"role":35,"phone":36,"phoneExt":24,"email":37},{"name":30,"role":35,"phone":39,"phoneExt":24,"email":40},{"type":60,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"SPONSOR_INVESTIGATOR","Hongying Jiang, MD","Principal Investigator",[64,66,69,71],{"name":65,"class":6},"Beijing Rehabilitation Hospital",{"name":67,"class":68},"Hunan Provincial Rehabilitation Hospital","UNKNOWN",{"name":70,"class":6},"Beijing Tiantan Hospital",{"name":72,"class":68},"Beijing Fengtai Rehabilitation Hospital","100626445","comparison-of-speaking-valve-trial-and-capping-trial-for-tracheostomy-decannulation-in-stroke-patients-100626445",false,"NCT07435727","Comparison of Speaking Valve Trial and Capping Trial for Tracheostomy Decannulation in Stroke Patients","Comparison of Speaking Valve Trial and Capping Trial in the Decannulation Process for Stroke Patients: A Randomized, Controlled, Multicenter Study","Inclusion Criteria:\n\nStroke (ischemic or hemorrhagic) with subsequent tracheostomy. Stable stage of stroke: clinically in the post-acute or sequelae stage, with stable vital signs, resolved cerebral edema, normalized intracranial pressure, no new neurological deficits.\n\nClinically stable, defined as: ventilator-free for ≥48 hours prior to enrollment; stable vital signs (temperature \\\u003C38°C, heart rate 60-100 bpm, respiratory rate \\\u003C20\u002Fmin, systolic blood pressure 90-160 mmHg); no active severe infection requiring IV antibiotics; no organ failure; partial pressure of Carbon Dioxide(PaCO₂) \\\u003C60 mmHg.\n\nPeak Cough Flow (PCF) ≥100 L\u002Fmin. 24-hour subglottic secretion volume \\\u003C20 ml. Signed informed consent by patient or legal representative.\n\nExclusion Criteria:\n\nIntolerance to cuff deflation: severe cough, dyspnea, SpO₂ \\\u003C93% (on supplemental oxygen), or respiratory rate \\>20\u002Fmin for \\>5 minutes.\n\nSevere airway structural abnormalities: tracheal stenosis (\\>50% lumen occlusion confirmed by Computed Tomography or bronchoscopy), tracheoesophageal fistula.\n\nLife expectancy \\\u003C2 weeks or planned transfer to a non-participating institution within 2 weeks.\n\nSevere uncontrolled neurological or systemic diseases (e.g., advanced cancer, severe heart failure).","ALL","18 Years","80 Years",{"count":84,"type":85},120,"ESTIMATED","INTERVENTIONAL",[88],"NA","This study aims to compare the efficacy and safety of the Speaking Valve trial versus the traditional Capping trial as indicators for tracheostomy decannulation in stroke patients. The trial is a prospective, multicenter, randomized, parallel-group, outcomes-assessor-blinded study with an exploratory crossover design.",[91],"Stroke","2026-05-19",{"date":94,"type":95},"2026-05-22","ACTUAL",{"date":97,"type":85},"2026-05-15",{"date":99,"type":85},"2027-08-15",{"name":61,"class":6},1]