[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608197":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":15,"centralContacts":20,"locations":7,"responsibleParty":29,"collaborators":32,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":7,"eligibilityCriteria":43,"healthyVolunteers":39,"sex":44,"minAge":45,"maxAge":46,"enrollmentInfo":47,"targetDuration":7,"studyType":50,"phases":7,"briefSummary":51,"conditions":52,"keywords":55,"overallStatus":58,"whyStopped":7,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":7},{"fullName":5,"class":6},"Capital Medical University","OTHER",null,[9,12],{"type":6,"name":10,"description":11,"armGroupLabels":7,"otherNames":7},"Successful decannulation group","Patients who successfully completed the decannulation process and had their tubes removed, with no reinsertion of the tracheostomy tube or endotracheal intubation within 48 hours after decannulbation.",{"type":6,"name":13,"description":14,"armGroupLabels":7,"otherNames":7},"Failed decannulation group","Patients who did not pass the decannulation process, and the multidisciplinary team advised against removal of the tracheostomy tube; or patients who passed the decannulation process and had the tracheostomy tube removed but required reinsertion of the tracheostomy tube or endotracheal intubation within 48 hours due to medical conditions.",[16],{"name":17,"affiliation":18,"role":19},"Hongying Jiang","Beijing Rehabilitation Hospital of Capital Medical University, Beijing, China","STUDY_CHAIR",[21,26],{"name":22,"role":23,"phone":24,"phoneExt":7,"email":25},"Bin Zhang","CONTACT","+8618600530758","zbzgzjz@sina.com",{"name":17,"role":23,"phone":27,"phoneExt":7,"email":28},"+8601056981555","6jhy@163.com",{"type":30,"investigatorFullName":22,"investigatorTitle":31,"investigatorAffiliation":5,"oldNameTitle":7,"oldOrganization":7},"SPONSOR_INVESTIGATOR","Principal Investigator",[33,35],{"name":34,"class":6},"Beijing Rehabilitation Hospital",{"name":36,"class":6},"Chinese PLA General Hospital","100608197","predicting-success-of-decannulation-using-wearable-derived-physiology-100608197",false,"NCT07198425","Predicting Success of Decannulation Using Wearable-derived Physiology","Predicting Success of Decannulation Using Wearable-derived Physiology : A Prospective Cohort Study","Inclusion Criteria:\n\n* 18 years ≤ Age ≤ 90 years, non-mechanically ventilated patients.\n* Tracheotomy completed, ≥48 hours since cannula placement (postoperative early edema has stabilized).\n* Patient or legal representative has provided informed consent.\n\nExclusion Criteria:\n\n* Recent (≤48 hours) major neck\u002Fupper airway surgery requiring avoidance of upper airway airflow impact.\n* Severe consciousness disorder\u002Fdelirium (RASS ≤ -3 or ≥ +2), extreme anxiety\u002Finability to cooperate.\n* Total laryngectomy or laryngo-tracheal separation.\n* Oral endotracheal intubation.\n* Age \\\u003C18 years, Age \\> 90years.\n* Malignant tumor with an expected survival time ≤ 6 months.\n* Patients or legal representatives unable to obtain informed consent.\n* Known contraindications for tracheotomy decannulation.\n* Unable to comply with the use of wearable devices","ALL","18 Years","90 Years",{"count":48,"type":49},120,"ESTIMATED","OBSERVATIONAL","The population included in this study consists of tracheostomy patients admitted to the pulmonary department of Beijing Rehabilitation Hospital, undergoing decannulation rehabilitation treatment. Once patient conditions stabilized, they were all transitioned to the decannulation process established by our department in 2018, which utilizes a speaking valve instead of capping. Each enrolled patient received physiological monitoring upon admission and the day prior to the initial use of the speaking valve, with continuous monitoring for 24 hours through wearable devices.The monitored physiological parameters were compared between the successful decannulation group and the failed decannulation group, and a predictive decannulation model was established in advance based on clinical parameters.\n\nDecannulation criteria: If the patient can tolerate wearing the speaking valve continuously for 4 hours (gradually increasing the duration: 30 minutes, 1 hour, 2 hours, 4 hours), and if PEF \\> 100 liters\u002Fmin, planned removal of the tracheostomy tube can be considered.\n\nBased on decannulation outcomes, patients were categorized into the successful decannulation group and the failed decannulation group.\n\nSuccessful decannulation group: Patients who successfully completed the decannulation process and had their tubes removed, with no reinsertion of the tracheostomy tube or endotracheal intubation within 48 hours after decannulation.\n\nFailed decannulation group: Patients who did not pass the decannulation process, and the multidisciplinary team advised against removal of the tracheostomy tube; or patients who passed the decannulation process and had the tracheostomy tube removed but required reinsertion of the tracheostomy tube or endotracheal intubation within 48 hours due to medical conditions.",[53,54],"Tracheostomy Decannulation","Physiological Parameter",[56,54,57],"speaking valve","tracheostomy decannulation","NOT_YET_RECRUITING","2026-05-23",{"date":61,"type":62},"2026-05-28","ACTUAL",{"date":64,"type":49},"2026-06-02",{"date":66,"type":49},"2026-12-31",{"name":22,"class":6}]