[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Bin Zhang\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":91},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,66],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":4},"100625558","physiological-benefits-from-the-removal-of-tracheostomy-tubes-obtained-via-wearable-devices-100625558",false,"NCT07424196","Physiological Benefits From the Removal of Tracheostomy Tubes (Obtained Via Wearable Devices)","Collect Physiological Data of Patients Before and After Tracheostomy Tube Removal Using Wearable Devices to Quantify Physiological Benefits of Decannulation","RVTR1","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* Following our department's 2018 decannulation procedure, patients who successfully completed decannulation\n\nExclusion Criteria:\n\n* Patients with abnormal skin conditions preventing continuous wearing of monitoring devices;\n* Interruption of physiological monitoring data;\n* Poor quality of physiological monitoring data;\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* 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":21,"type":22},60,"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. After the patient is admitted, the research team evaluates whether they are suitable to enter the decannulation process. For enrolled patients, a 24-hour wearable device is worn upon admission to record physiological parameters.\n\nPatients, following clinical and rehabilitation treatment, can start using a \"speaking valve\" as soon as their condition permits. Within the first 24 hours prior to the initial use of the speaking valve, wearable devices may be utilized a second time to gather data.\n\nPatients successfully completed the decannulation process, tolerating the speaking valve for 4 hours (PEF\u002FPCF ≥ 100liters\u002Fmin).The wearable device was utilized to gather 24 hours physiological parameters for the third time within the 24 hours leading up to decannulation.\n\nPatients who underwent successful decannulation had physiological parameters collected for the forth time using wearable devices within 24 hours prior to discharge.\n\nThis study preliminarily compares the differences in physiological parameters at four time points (within 24 hours of admission, within 24 hours prior to using a speaking valve, within 24 hours prior to decannulation and within 24 hours before discharge), predicts the physiological benefits of decannulation for patients, and advocates for the concept of \"early decannulation.\" Decannulation 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\u002FPCF ≥ 100 liters\u002Fmin, planned removal of the tracheostomy tube can be considered.\n\nCriteria for successful decannulation: 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.",[26,27,28],"Physiological Parameters","Wearable Devices","Tracheostomy Decannulation",[30,26,27,31],"speaking valve","Tracheostomy decannulation","NOT_YET_RECRUITING","2026-05-30",{"date":35,"type":36},"2026-06-03","ACTUAL",{"date":38,"type":22},"2026-06-01",{"date":40,"type":22},"2027-03-30",{"name":42,"class":43},"Bin Zhang","OTHER",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":4},"100608197","predicting-success-of-decannulation-using-wearable-derived-physiology-100608197","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",{"count":52,"type":22},120,"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.",[28,55],"Physiological Parameter",[30,55,57],"tracheostomy decannulation","2026-05-23",{"date":60,"type":36},"2026-05-28",{"date":62,"type":22},"2026-06-02",{"date":64,"type":22},"2026-12-31",{"name":42,"class":43},{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":73,"targetDuration":4,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":89,"locationsCount":90},"100639533","predicting-the-clinical-advantages-of-speaking-valves-through-wearable-devices-100639533","NCT07587762","Predicting the Clinical Advantages of Speaking Valves Through Wearable Devices","Predicting the Clinical Advantages of Speaking Valves Through Wearable Devices:A Prospective Cohort Study","Inclusion Criteria:\n\n* 90 years≥Age≥18 years;\n* Tracheotomy post-operation\\>48 hours；\n* Weaned off mechanical ventilation;\n* Clinically stable condition;\n* Tolerable for cuff deflation;\n* Able to tolerate wearing a speaking valve continuously for 30 minutes;\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Patients with abnormal skin conditions preventing continuous wearing of monitoring devices;\n* Inability to tolerate wearing a speaking valve continuously for 30 minutes;\n* Interruption of physiological monitoring data;\n* Poor quality of physiological monitoring data;\n* Recently underwent neck\u002Fupper airway surgery (≤48 hours, to avoid airflow impact on the upper airway);\n* Severe consciousness disturbance\u002Fdelirium (RASS score≤-3 or ≥ +2), extreme anxiety\u002Funcooperativeness;\n* Total laryngectomy or laryngotracheal separation;\n* Age \\\u003C18 years or \\>90 years;\n* Malignant tumor with an expected survival time ≤6 months;\n* The patient or legal representative is unable to sign the informed consent form.",{"count":52,"type":22},"INTERVENTIONAL",[76],"NA","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.The initial duration for the patient to wear the speaking valve is 30 minutes.The monitoring period for wearable devices is from 1 hour before the initial use of the speaking valve to 1 hour after its removal.Monitored for a total of 2 hours and 30 minutes.Explore the clinical benefits of the speaking valve by comparing the changes in patients' physiological parameters and clinical index metrics before and after using the speaking valve.\n\nCriteria for the successful use of the speaking valve for 30 minutes:\n\n1. Breathing is steady at rest: no apparent dyspnea, chest tightness, or orthopnea, etc.\n2. Heart rate, blood pressure, and SpO₂ are all stable overall.SpO₂ reduction from baseline \\\u003C 5%.\n3. No frequent need for emergency sputum suction or indications of sputum blockage while wearing it.",[55,27,79],"Tracheostomy",[30,27,81,55],"tracheostomy","RECRUITING","2026-05-11",{"date":85,"type":36},"2026-05-14",{"date":87,"type":36},"2026-04-16",{"date":64,"type":22},{"name":42,"class":43},1,""]