Actively Recruiting
Predicting the Clinical Advantages of Speaking Valves Through Wearable Devices
Led by Bin Zhang · Updated on 2026-05-14
120
Participants Needed
1
Research Sites
37 weeks
Total Duration
On this page
Sponsors
B
Bin Zhang
Lead Sponsor
C
Capital Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Predicting the Clinical Advantages of Speaking Valves Through Wearable Devices
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 90 years
- Tracheotomy performed more than 48 hours ago
- Weaned off mechanical ventilation
- Clinically stable condition
- Able to tolerate cuff deflation
- Able to wear a speaking valve continuously for 30 minutes
- Signed informed consent
You will not qualify if you...
- Abnormal skin conditions preventing continuous wearing of monitoring devices
- Unable to tolerate wearing a speaking valve continuously for 30 minutes
- Interrupted physiological monitoring data
- Poor quality of physiological monitoring data
- Recent neck or upper airway surgery within 48 hours
- Severe consciousness disturbance or delirium (RASS score ≤ -3 or ≥ +2), extreme anxiety, or uncooperativeness
- Total laryngectomy or laryngotracheal separation
- Age under 18 years or over 90 years
- Malignant tumor with expected survival time of 6 months or less
- Unable to sign informed consent form by patient or legal representative
AI-Screening
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Trial Site Locations
Total: 1 location
1
Beijing Rehabilitation Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100144
Actively Recruiting
Research Team
B
Bin Zhang
CONTACT
H
Hongying Jiang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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