Predicting the Clinical Advantages of Speaking Valves Through Wearable Devices
Predicting the Clinical Advantages of Speaking Valves Through Wearable Devices:A Prospective Cohort Study
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Beijing Municipality
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Beijing, Beijing Municipality, Porcelana, 100144
- Beijing Rehabilitation Hospital, Capital Medical University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Successfully wore the speaking valve for the first time for 30 minutes.
Inclusion Criteria：
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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.If the patient can tolerate wearing the speaking valve for 30 minutes, they fulfill the inclusion criteria.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. Physiological parameters recorded prior to wearing the speaking valve served as the baseline.Compare the physiological parameters while wearing the speaking valve and after its removal to investigate the clinical benefits that the speaking valve can provide.To promote the application of speaking valves in future clinical work more effectively |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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degree of change in oxygen saturation（%）
Periodo de tiempo: 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).
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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.
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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).
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Temporal rate of change of asymmetric cardiovascular responses and delayed autonomic recovery（percentage change from baseline）
Periodo de tiempo: 30 minutes before speaking valve placement, throughout the entire training session (i.e., during valve wear), and 30 minutes after the training session
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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
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30 minutes before speaking valve placement, throughout the entire training session (i.e., during valve wear), and 30 minutes after the training session
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Rate of respiratory phase variation during training（percentage change in phase duration）
Periodo de tiempo: 30 minutes before speaking valve placement, throughout the entire training session (i.e., during valve wear), and 30 minutes after the training session
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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.
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30 minutes before speaking valve placement, throughout the entire training session (i.e., during valve wear), and 30 minutes after the training session
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Hongying Jiang, Beijing Rehabilitation Hospital of Capital Medical University, Beijing, China
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 2026-bjkfyy-SVB
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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