RecruitingNANCT07587762

Predicting the Clinical Advantages of Speaking Valves Through Wearable Devices:A Prospective Cohort Study

Sponsor: Bin Zhang

Trial Details

ConditionPhysiological Parameter, Wearable Devices, Tracheostomy
InterventionTracheostomy patients who are able to tolerate wearing a speaking valve for 30 minutes
PhaseNA
StatusRecruiting
Participants120
Est. Completion1 June 2026
Last Updated14 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

China
View Registry Entry

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