Predicting the Clinical Advantages of Speaking Valves Through Wearable Devices:A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- degree of change in oxygen saturation（%）
研究概览
简要总结
The population included in this study consists of tracheostomy patients admitted to the pulmonary department of Beijing Rehabilitation Hospital, undergoing decannulation rehabilitation treatment. Once patient conditions stabilized, they were all transitioned to the decannulation process established by our department in 2018, which utilizes a speaking valve instead of capping.The initial duration for the patient to wear the speaking valve is 30 minutes.The monitoring period for wearable devices is from 1 hour before the initial use of the speaking valve to 1 hour after its removal.Monitored for a total of 2 hours and 30 minutes.Explore the clinical benefits of the speaking valve by comparing the changes in patients' physiological parameters and clinical index metrics before and after using the speaking valve.
Criteria for the successful use of the speaking valve for 30 minutes:
- Breathing is steady at rest: no apparent dyspnea, chest tightness, or orthopnea, etc.
- Heart rate, blood pressure, and SpO₂ are all stable overall.SpO₂ reduction from baseline < 5%.
- No frequent need for emergency sputum suction or indications of sputum blockage while wearing it.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •90 years≥Age≥18 years;
- •Tracheotomy post-operation>48 hours；
- •Weaned off mechanical ventilation;
- •Clinically stable condition;
- •Tolerable for cuff deflation;
- •Able to tolerate wearing a speaking valve continuously for 30 minutes;
- •Signed informed consent.
排除标准
- •Patients with abnormal skin conditions preventing continuous wearing of monitoring devices;
- •Inability to tolerate wearing a speaking valve continuously for 30 minutes;
- •Interruption of physiological monitoring data;
- •Poor quality of physiological monitoring data;
- •Recently underwent neck/upper airway surgery (≤48 hours, to avoid airflow impact on the upper airway);
- •Severe consciousness disturbance/delirium (RASS score≤-3 or ≥ +2), extreme anxiety/uncooperativeness;
- •Total laryngectomy or laryngotracheal separation;
- •Age <18 years or >90 years;
- •Malignant tumor with an expected survival time ≤6 months;
- •The patient or legal representative is unable to sign the informed consent form.
研究组 & 干预措施
Successfully wore the speaking valve for the first time for 30 minutes.
Inclusion Criteria：
- Breathing is steady at rest: no apparent dyspnea, chest tightness, or orthopnea, etc.
- Heart rate, blood pressure, and SpO₂ are all stable overall.SpO₂ reduction from baseline < 5%.
- No frequent need for emergency sputum suction or indications of sputum blockage while wearing it.
干预措施: Tracheostomy patients who are able to tolerate wearing a speaking valve for 30 minutes (Other)
结局指标
主要结局
degree of change in oxygen saturation（%）
时间窗: Using wearable biosensors, high-resolution physiological data were continuously collected during three phases: baseline (30 minutes), speaking valve placement period (30 minutes), and recovery period (30 minutes after speaking valve removal).
Previous studies have been concerned that speaking valve placement increases upper airway resistance, thereby inducing dyspnea and hypoxemia in patients. Therefore, we used continuous wearable physiological monitoring devices to observe changes in oxygen saturation before, during, and after the training.
Temporal rate of change of asymmetric cardiovascular responses and delayed autonomic recovery（percentage change from baseline）
时间窗: 30 minutes before speaking valve placement, throughout the entire training session (i.e., during valve wear), and 30 minutes after the training session
The rate of change (percentage per minute) in asymmetric cardiovascular responses (e.g., heart rate variability indices) and delayed autonomic recovery will be calculated. Physiological data (heart rate, HRV metrics) are continuously collected before, during, and after speaking valve placement. The primary reported value is the slope of change over time, expressed as a percentage relative to baseline, aggregated across all participants using mixed-effects modeling to produce a single mean rate of change
Rate of respiratory phase variation during training（percentage change in phase duration）
时间窗: 30 minutes before speaking valve placement, throughout the entire training session (i.e., during valve wear), and 30 minutes after the training session
The rate of change in respiratory phase variation (e.g., changes in inspiratory/expiratory time proportion) during speaking valve training. Respiratory parameters are continuously recorded. The outcome is the calculated rate of change (percentage per minute) from baseline to the active training period and to the recovery period. A single aggregated value (mean slope) will be derived from all participants using linear mixed models.
次要结局
未报告次要终点
研究者
Bin Zhang
Principal Investigator
Capital Medical University