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Predicting the Clinical Advantages of Speaking Valves Through Wearable Devices

NCT07587762 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-05-14

No results posted yet for this study

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.

Conditions

  • Physiological Parameter
  • Wearable Devices
  • Tracheostomy

Interventions

OTHER

Tracheostomy 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

Sponsors & Collaborators

  • Capital Medical University

    collaborator OTHER

  • Chinese PLA General Hospital

    collaborator OTHER

  • Bin Zhang

    lead OTHER

Principal Investigators

  • Hongying Jiang · Beijing Rehabilitation Hospital of Capital Medical University, Beijing, China

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-16
Primary Completion
2026-06-01
Completion
2026-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07587762 on ClinicalTrials.gov