The Effect of Speaking Valve on Physiological Parameters With Wearable Devices

N/ANot Yet RecruitingNCT07422350

Jingyi Ge120 enrolled

Overview

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

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

120

Conditions

Tracheostomy Decannulation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Locations (1)

Beijing Rehabilitation Hospital, Capital Medical University, Beijing,China

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

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.

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).

Central Contacts

Bin Zhang

CONTACT

+8618600530758 zbzgzjz@sina.com

Data from ClinicalTrials.gov

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