[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626445":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":39,"studyPopulation":29,"armGroups":40,"interventions":53,"overallOfficials":60,"centralContacts":64,"locations":73,"responsibleParty":91,"collaborators":95,"id":105,"slug":29,"hasResults":106,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":29,"eligibilityCriteria":110,"healthyVolunteers":106,"sex":111,"minAge":112,"maxAge":113,"enrollmentInfo":114,"targetDuration":29,"studyType":117,"phases":118,"briefSummary":120,"conditions":121,"keywords":29,"overallStatus":76,"whyStopped":29,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"Capital Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":29},[9],{"measure":10,"description":11,"timeFrame":12},"Decannulation Success Rate","Proportion of participants with successful decannulation and no reintubation within 48 hours, based on total randomized participants.","48 hours post-decannulation",[14,18,22,26],{"measure":15,"description":16,"timeFrame":17},"Time to Decannulation","Number of days from randomization to successful decannulation.","From randomization to decannulation, assessed up to 30 days",{"measure":19,"description":20,"timeFrame":21},"Pneumonia Incidence at 30 Days","Proportion of decannulated participants diagnosed with pneumonia within 30 days","30 days post-decannulation",{"measure":23,"description":24,"timeFrame":25},"Reintubation Rate at 90 Days","Proportion of participants requiring reintubation within 90 days","90 days post-decannulation",{"measure":27,"description":28,"timeFrame":25},"Mortality Rate at 90 Days","All-cause mortality within 90 days",null,{"allocation":31,"interventionModel":32,"interventionModelDescription":33,"primaryPurpose":34,"observationalModel":29,"timePerspective":29,"maskingInfo":35},"RANDOMIZED","CROSSOVER","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.","TREATMENT",{"masking":36,"maskingDescription":29,"whoMasked":37},"SINGLE",[38],"OUTCOMES_ASSESSOR","Stroke survivors may develop disorders of consciousness, dysphagia, and airway dysfunction, with some requiring tracheostomy for prolonged mechanical ventilation or airway protection. Prolonged tracheostomy tube placement can lead to complications such as infection, tracheal stenosis, and communication difficulties. Timely and safe decannulation is crucial for rehabilitation. While the capping trial (typically 48-72 hours) is widely used, the speaking valve offers potential advantages by restoring physiological airflow and facilitating communication. This trial will systematically compare these two methods to provide evidence for optimizing decannulation protocols.",[41,47],{"label":42,"type":43,"description":44,"interventionNames":45},"Speaking Valve Group","EXPERIMENTAL","Passy-Muir Speaking Valve",[46],"Other: Passy-Muir Speaking Valve",{"label":48,"type":49,"description":50,"interventionNames":51},"Capping Group","ACTIVE_COMPARATOR","Tracheostomy tube capping",[52],"Other: Tracheostomy tube capping",[54,57],{"type":6,"name":44,"description":55,"armGroupLabels":56,"otherNames":29},"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.",[42],{"type":6,"name":50,"description":58,"armGroupLabels":59,"otherNames":29},"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.",[48],[61],{"name":62,"affiliation":5,"role":63},"Hongying Jiang","STUDY_CHAIR",[65,70],{"name":66,"role":67,"phone":68,"phoneExt":29,"email":69},"Qian Feng","CONTACT","17207122873","fengqian0263@163.com",{"name":62,"role":67,"phone":71,"phoneExt":29,"email":72},"56981555","6jhy@163.com",[74],{"facility":75,"status":76,"city":77,"state":78,"zip":79,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":87,"contacts":88},"Beijing Rehabilitation Hospital, Capital Medical University","RECRUITING","Beijing","Beijing Municipality","100043","China","CN",{"type":83,"coordinates":84},"Point",[85,86],116.39723,39.9075,{"lat":86,"lon":85},[89,90],{"name":66,"role":67,"phone":68,"phoneExt":29,"email":69},{"name":62,"role":67,"phone":71,"phoneExt":29,"email":72},{"type":92,"investigatorFullName":93,"investigatorTitle":94,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"SPONSOR_INVESTIGATOR","Hongying Jiang, MD","Principal Investigator",[96,98,101,103],{"name":97,"class":6},"Beijing Rehabilitation Hospital",{"name":99,"class":100},"Hunan Provincial Rehabilitation Hospital","UNKNOWN",{"name":102,"class":6},"Beijing Tiantan Hospital",{"name":104,"class":100},"Beijing Fengtai Rehabilitation Hospital","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":115,"type":116},120,"ESTIMATED","INTERVENTIONAL",[119],"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.",[122],"Stroke","2026-05-19",{"date":125,"type":126},"2026-05-22","ACTUAL",{"date":128,"type":116},"2026-05-15",{"date":130,"type":116},"2027-08-15",{"name":93,"class":6},1]