The Effect of Speaking Valve on Physiological Parameters With Wearable Devices
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Tracheostomy Decannulation. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Speaking Valve on Physiological Parameters of Tracheostomized Patients With Wearable Devices
Overview
To explore the effect of speaking valves on physiological parameters of tracheostomized patients with wearable devices.
Detailed description
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.
Primary outcome measures
- Comparison of differences in key physiological parameters between two patient groups [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).]
Eligibility criteria
Inclusion criteria
- Patient is not receiving mechanical ventilation.
- Tolerates cuff deflation.
- Upper airway patency is good, TTP < 10 cmH2O.
- Hemodynamically stable, no organ failure, and no sepsis, Pulmonary infection is controlled.
- PaCO2<60 mmHg.
Exclusion criteria
- Cannot tolerate deflation balloon.
- Severe upper airway obstruction
- Unstable vital signs.
- Thick secretions, compromised airway protection.
- PaCO2 ≥60 mmHg.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Beijing Rehabilitation Hospital, Capital Medical University, Beijing,China — Beijing
Identifiers
NCT: NCT07422350 · 2025-bjkfyy-twdmp-svt