The Effect of Speaking Valve on Physiological Parameters of Tracheostomized Patients With Wearable Devices
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Comparison of differences in key physiological parameters between two patient groups
研究概览
简要总结
To explore the effect of speaking valves on physiological parameters of tracheostomized patients with wearable devices.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Cannot tolerate deflation balloon.
- •Severe upper airway obstruction
- •Unstable vital signs.
- •Thick secretions, compromised airway protection.
- •PaCO2 ≥60 mmHg.
研究组 & 干预措施
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.
结局指标
主要结局
Comparison of differences in key physiological parameters between two patient groups
时间窗: 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.
次要结局
未报告次要终点
研究者
Jingyi Ge
Principal Investigator
Capital Medical University