Predicting the Clinical Advantages of Speaking Valves Through Wearable Devices:A Prospective Cohort Study
Sponsor: Bin Zhang
Trial Details
| Condition | Physiological Parameter, Wearable Devices, Tracheostomy |
| Intervention | Tracheostomy patients who are able to tolerate wearing a speaking valve for 30 minutes |
| Phase | NA |
| Status | Recruiting |
| Participants | 120 |
| Est. Completion | 1 June 2026 |
| Last Updated | 14 May 2026 |
Primary Outcome
degree of change in oxygen saturation(%); Temporal rate of change of asymmetric cardiovascular responses and delayed autonomic recovery(percentage change from baseline); Rate of respiratory phase variation during training(percentage change in phase duration)
Eligibility Criteria
Inclusion Criteria
Inclusion Criteria: * 90 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 Criteria: * 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.
Trial Sites
Countries
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