To explore the effect of speaking valves on physiological parameters of tracheostomized patients with wearable devices.
Eligibility
Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
Inclusion Criteria:
1. Patient is not receiving mechanical ventilation.
2. Tolerates cuff deflation.
3. Upper airway patency is good, TTP \< 10 cmH2O.
4. Hemodynamically stable, no organ failure, and no sepsis, Pulmonary infection is controlled.
5. PaCO2\<60 mmHg.
Exclusion Criteria:
1. Cannot tolerate deflation balloon.
2. Severe upper airway obstruction
3. Unstable vital signs.
4. Thick secretions, compromised airway protection.
5. PaCO2 ≥60 mmHg.
Primary outcome measure(s)
Comparison of differences in key physiological parameters between two patient groups — 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.
Trial sites (1)
Facility
City
Region
Status
Beijing Rehabilitation Hospital, Capital Medical University, Beijing,China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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