Predicting the Clinical Advantages of Speaking Valves Through Wearable Devices
Predicting the Clinical Advantages of Speaking Valves Through Wearable Devices:A Prospective Cohort Study
Bin Zhang
120 participants
Apr 16, 2026
INTERVENTIONAL
Conditions
Summary
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. Criteria for the successful use of the speaking valve for 30 minutes: 1. Breathing is steady at rest: no apparent dyspnea, chest tightness, or orthopnea, etc. 2. Heart rate, blood pressure, and SpO₂ are all stable overall.SpO₂ reduction from baseline \< 5%. 3. No frequent need for emergency sputum suction or indications of sputum blockage while wearing it.
Eligibility
Inclusion Criteria7
- years≥Age≥18 years;
- Tracheotomy post-operation>48 hours；
- Weaned off mechanical ventilation;
- Clinically stable condition;
- Tolerable for cuff deflation;
- Able to tolerate wearing a speaking valve continuously for 30 minutes;
- Signed informed consent.
Exclusion Criteria10
- Patients with abnormal skin conditions preventing continuous wearing of monitoring devices;
- Inability to tolerate wearing a speaking valve continuously for 30 minutes;
- Interruption of physiological monitoring data;
- Poor quality of physiological monitoring data;
- Recently underwent neck/upper airway surgery (≤48 hours, to avoid airflow impact on the upper airway);
- Severe consciousness disturbance/delirium (RASS score≤-3 or ≥ +2), extreme anxiety/uncooperativeness;
- Total laryngectomy or laryngotracheal separation;
- Age <18 years or >90 years;
- Malignant tumor with an expected survival time ≤6 months;
- The patient or legal representative is unable to sign the informed consent form.
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Interventions
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.If the patient can tolerate wearing the speaking valve for 30 minutes, they fulfill the inclusion criteria.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. Physiological parameters recorded prior to wearing the speaking valve served as the baseline.Compare the physiological parameters while wearing the speaking valve and after its removal to investigate the clinical benefits that the speaking valve can provide.To promote the application of speaking valves in future clinical work more effectively
Locations(1)
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NCT07587762