Beijing Rehabilitation Hospital, Capital Medical University, Beijing,China
Beijing, Beijing Municipality, 100043, China
NCT Number: NCT07422350
To explore the effect of speaking valves on physiological parameters of tracheostomized patients with wearable devices.
Trial opening soon.
Get Notified18 year–90 year
All sexes
Observational
Beijing, Beijing Municipality, 100043, China
A speaking valve (such as the common one-way valve/Passy-Muir type) is a one-way device attached to the external opening of a tracheostomy tube: the valve opens during inhalation, allowing air to flow in through the tracheostomy tube; it closes during exhalation, directing airflow upwards through the glottis and out through the mouth and nose, thereby restoring upper airway exhalation, vibrating the vocal cords to produce sound, and enhancing functions such as swallowing, smell, taste, and secretion clearance. This study aims to gather physiological parameter data using non-invasive wearable devices during speaking valve use, compare the differences between before and after wearing speaking valve.It also compares key physiological parameters between the group that can tolerate the speaking valve and the group that cannot. Identify objective indicators associated with successful tolerance.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Specified assessment window:From 1 hour before initiation of speaking valve use to 1 hour after speaking valve removal (wearable devices monitoring period).
Primary endpoint: Whether the tracheostomy patient's first use of a speaking valve is successful,duration of use 30 minutes.Primary Objectives:Data from 120 patients were collected using wearable devices,including respiratory rate(RR),heart rate(HR),fingertip blood oxygen saturation(SaO₂),respiratory movement amplitude(RMA),etc.RR and HR refer to the average respiratory and heart rates per minute during monitoring,respectively(breaths/min,beats/min).SaO₂ represents the average oxygen saturation recorded during monitoring(%).RMA means the average thoracic respiratory movement amplitude during monitoring(mm).This study aims to identify factors that can predict successful tolerance of the speaking valve, enhance the decannulation process focused on the "speaking valve," and increase the the success rate of decannulation.
Contact information is provided by the study sponsor or research team.
Jingyi Ge
Other
The Effect of Speaking Valve on Physiological Parameters of Tracheostomized Patients With Wearable Devices
Acronym: Effect of SV
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