[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625416":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":15,"locations":21,"responsibleParty":40,"collaborators":44,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":10,"studyType":65,"phases":10,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":74,"whyStopped":10,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Capital Medical University","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Tolerance Cohort",null,"Tolerance group: Successfully wears a speaking valve for the predefined time threshold (first wearing time = 30 minutes), with a Borg dyspnea score ≤ 3, and no significant CO₂ retention (PaCO₂ \\\u003C 60 mmHg).",{"label":13,"type":10,"description":14,"interventionNames":10},"Intolerance Cohort","Intolerance group: occurrence of any of the following during the 30-minute wearing period-marked increase in subjective dyspnea score; need for premature speaking valves removal; sustained SaO2 decrease ≥3%; severe or persistent cough; decompensated respiratory acidosis or PaCO2 ≥ 60 mmHg.",[16],{"name":17,"role":18,"phone":19,"phoneExt":10,"email":20},"Bin Zhang","CONTACT","+8618600530758","zbzgzjz@sina.com",[22],{"facility":23,"status":10,"city":24,"state":25,"zip":26,"country":27,"countryCode":28,"cosmosGeoPoint":29,"geoPoint":34,"contacts":35},"Beijing Rehabilitation Hospital, Capital Medical University, Beijing,China","Beijing","Beijing Municipality","100043","China","CN",{"type":30,"coordinates":31},"Point",[32,33],116.39723,39.9075,{"lat":33,"lon":32},[36],{"name":37,"role":18,"phone":38,"phoneExt":10,"email":39},"Hong ying Jiang","+8601056981555","6jhy@163.com",{"type":41,"investigatorFullName":42,"investigatorTitle":43,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Jingyi Ge","Principal Investigator",[45,47,49],{"name":46,"class":6},"Beijing Rehabilitation Hospital",{"name":48,"class":6},"Peking University Cancer Hospital & Institute",{"name":50,"class":6},"Chinese PLA General Hospital","100625416","the-effect-of-speaking-valve-on-physiological-parameters-with-wearable-devices-100625416",false,"NCT07422350","The Effect of Speaking Valve on Physiological Parameters With Wearable Devices","The Effect of Speaking Valve on Physiological Parameters of Tracheostomized Patients With Wearable Devices","Effect of SV","Inclusion Criteria:\n\n1. Patient is not receiving mechanical ventilation.\n2. Tolerates cuff deflation.\n3. Upper airway patency is good, TTP \\\u003C 10 cmH2O.\n4. Hemodynamically stable, no organ failure, and no sepsis, Pulmonary infection is controlled.\n5. PaCO2\\\u003C60 mmHg.\n\nExclusion Criteria:\n\n1. Cannot tolerate deflation balloon.\n2. Severe upper airway obstruction\n3. Unstable vital signs.\n4. Thick secretions, compromised airway protection.\n5. PaCO2 ≥60 mmHg.","ALL","18 Years","90 Years",{"count":63,"type":64},120,"ESTIMATED","OBSERVATIONAL","To explore the effect of speaking valves on physiological parameters of tracheostomized patients with wearable devices.",[68],"Tracheostomy Decannulation",[70,71,72,73],"difficult decannulation","tracheostomized patients","Wearable devices","speaking valves","NOT_YET_RECRUITING","2026-02-12",{"date":77,"type":78},"2026-02-20","ACTUAL",{"date":80,"type":64},"2026-01-31",{"date":82,"type":64},"2026-12-31",{"name":42,"class":6},1]