The Effect of Speaking Valve on Physiological Parameters With Wearable Devices

NCT07422350 | Not Yet Recruiting DMC

• 1 other identifier: 2025-bjkfyy-twdmp-svt
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

To explore the effect of speaking valves on physiological parameters of tracheostomized patients with wearable devices.

Conditions

Tracheostomy Decannulation

Keywords

difficult decannulation; tracheostomized patients; Wearable devices; speaking valves

Outcome Measures

Primary Outcomes (1)

• Comparison of differences in key physiological parameters between two patient groups

  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.

  Specified assessment window:From 1 hour before initiation of speaking valve use to 1 hour after speaking valve removal (wearable devices monitoring period).

Study Arms (2)

Tolerance Cohort

Tolerance group: Successfully wears a speaking valve for the predefined time threshold (first wearing time = 30 minutes), with a Borg dyspnea score ≤ 3, and no significant CO₂ retention (PaCO₂ \< 60 mmHg).

Intolerance Cohort

Intolerance group: occurrence of any of the following during the 30-minute wearing period-marked increase in subjective dyspnea score; need for premature speaking valves removal; sustained SaO2 decrease ≥3%; severe or persistent cough; decompensated respiratory acidosis or PaCO2 ≥ 60 mmHg.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Population:Tracheostomy patients in a rehabilitation hospital undergoing pre-decannulation rehabilitation

You may qualify if:

• 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.

You may not qualify if:

• Cannot tolerate deflation balloon.
• Severe upper airway obstruction
• Unstable vital signs.
• Thick secretions, compromised airway protection.
• PaCO2 ≥60 mmHg.

Sponsors & Collaborators

• Jingyi Ge: lead
• Beijing Rehabilitation Hospital: collaborator
• Peking University Cancer Hospital & Institute: collaborator
• Chinese PLA General Hospital: collaborator

Study Sites (1)

Beijing Rehabilitation Hospital, Capital Medical University, Beijing,China

Beijing, Beijing Municipality, 100043, China

Location

Central Study Contacts

Bin Zhang

CONTACT

+8618600530758; zbzgzjz@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 7, 2025
• First Posted: February 20, 2026
• Study Start: January 31, 2026
• Primary Completion (Estimated): October 20, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)