Predicting the Clinical Advantages of Speaking Valves Through Wearable Devices
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorBin Zhang
About this trial
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:
1. Breathing is steady at rest: no apparent dyspnea, chest tightness, or orthopnea, etc. 2. Heart rate, blood pressure, and SpO₂ are all stable overall.SpO₂ reduction from baseline \< 5%. 3. No frequent need for emergency sputum suction or indications of sputum blockage while wearing it.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
90 years≥Age≥18 years;
Tracheotomy post-operation>48 hours；
Weaned off mechanical ventilation;
Clinically stable condition;
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
Tracheostomy patients who are able to tolerate wearing a speaking valve for 30 minutes
Other interventionOnce 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
Treatment groups
120 Participants
are divided into 1 treatment groupGroup A: Successfully wore the speaking valve for the first time for 30 minutes.Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
degree of change in oxygen saturation（%）
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.
Time frame
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).2
Temporal rate of change of asymmetric cardiovascular responses and delayed autonomic recovery（percentage change from baseline）
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
Time frame
30 minutes before speaking valve placement, throughout the entire training session (i.e., during valve wear), and 30 minutes after the training session3
Rate of respiratory phase variation during training（percentage change in phase duration）
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.
Time frame
30 minutes before speaking valve placement, throughout the entire training session (i.e., during valve wear), and 30 minutes after the training sessionSponsors and contacts
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Bin Zhang
Lead sponsor
Capital Medical University
Sponsor institution
Capital Medical University
Collaborator
Chinese PLA General Hospital
Collaborator
Source ClinicalTrials.gov