The Effect of Speaking Valve on Physiological Parameters With Wearable Devices
ConditionTracheostomy Decannulation
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorJingyi Ge
About this trial
To explore the effect of speaking valves on physiological parameters of tracheostomized patients with wearable devices.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Cannot tolerate deflation balloon.
Severe upper airway obstruction
Unstable vital signs.
Thick secretions, compromised airway protection.
Trial population
Population:Tracheostomy patients in a rehabilitation hospital undergoing pre-decannulation rehabilitation
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
120 Participants
are grouped into 2 trial groupsGroup A: Tolerance Cohort
Group B: Intolerance Cohort
Trial outcomes
Primary outcomes
1
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).Sponsors and contacts
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Jingyi Ge
Lead sponsor
Capital Medical University
Sponsor institution
Beijing Rehabilitation Hospital
Collaborator
Peking University Cancer Hospital & Institute
Collaborator
Chinese PLA General Hospital
Collaborator
Source ClinicalTrials.gov
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