The Effect of Speaking Valve on Physiological Parameters With Wearable Devices (Effect of SV)

The Effect of Speaking Valve on Physiological Parameters of Tracheostomized Patients With Wearable Devices

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

Study Overview

• Status: Not yet recruiting
• Conditions: Tracheostomy Decannulation

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.

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Bin Zhang; Phone Number: +8618600530758; Email: zbzgzjz@sina.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100043
      • Beijing Rehabilitation Hospital, Capital Medical University, Beijing,China
      • Contact: Hong ying Jiang; Phone Number: +8601056981555; Email: 6jhy@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

1. Patient is not receiving mechanical ventilation.
2. Tolerates cuff deflation.
3. Upper airway patency is good, TTP < 10 cmH2O.
4. Hemodynamically stable, no organ failure, and no sepsis, Pulmonary infection is controlled.
5. PaCO2<60 mmHg.

Exclusion Criteria:

1. Cannot tolerate deflation balloon.
2. Severe upper airway obstruction
3. Unstable vital signs.
4. Thick secretions, compromised airway protection.
5. PaCO2 ≥60 mmHg.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).

Collaborators and Investigators

• Sponsor: Jingyi Ge
• Collaborators: Chinese PLA General Hospital; Peking University Cancer Hospital & Institute; Beijing Rehabilitation Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 31, 2026
• Primary Completion (Estimated): October 20, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: September 7, 2025
• First Submitted That Met QC Criteria: February 12, 2026
• First Posted (Actual): February 20, 2026

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Wearable devices; tracheostomized patients; difficult decannulation; speaking valves
• Other Study ID Numbers: 2025-bjkfyy-twdmp-svt

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No