Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07422350

The Effect of Speaking Valve on Physiological Parameters With Wearable Devices

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Rehabilitation Hospital, Capital Medical University, Beijing,China

Beijing, Beijing Municipality, 100043, China

Location contact

Hong ying Jiang

CONTACT

[email protected]

+8601056981555

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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).

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Jingyi Ge

Other

Collaborators

  • Beijing Rehabilitation Hospital of Capital Medical University
  • Chinese PLA General Hospital
  • Peking University Cancer Hospital & Institute

Registry information

Official study title

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

Acronym: Effect of SV

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 20, 2026
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.