RecruitingNot ApplicableNCT07587762

Predicting the Clinical Advantages of Speaking Valves Through Wearable Devices

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


Sponsor

Bin Zhang

Enrollment

120 participants

Start Date

Apr 16, 2026

Study Type

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

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Tracheostomy patients who are able to tolerate wearing a speaking valve for 30 minutes for people with physiological parameter, tracheostomy, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERTracheostomy patients who are able to tolerate wearing a speaking valve for 30 minutes

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)

Beijing Rehabilitation Hospital, Capital Medical University

Beijing, Beijing Municipality, China

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NCT07587762


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