Early Speaking Valve in Ventilator Weaning: Effects on Communication, Depression, and Quality of Life
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFar Eastern Memorial Hospital
About this trial
This study evaluates the impact of early tracheostomy speaking valve intervention on communication ability, depression levels, and quality of life in ventilator-dependent patients during the weaning phase. Participants will be randomly assigned to either an experimental group using the Passy-Muir speaking valve or a control group employing standard non-verbal communication methods. Structured questionnaires will be used at multiple time points to assess changes in patient outcomes. The study aims to provide evidence supporting the use of speaking valves to enhance communication and emotional well-being in tracheostomy patients, potentially improving recovery and care strategies.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age: ≥18 years old
Consciousness: Glasgow Coma Scale (GCS) score 13-15 (can voluntarily open eyes or respond when called, able to follow instructions to move)
Tracheostomy: Performed ≥24 hours, with no bleeding, pain, subcutaneous emphysema, pneumothorax, or infection
Ventilator Weaning: Trained according to the hospital's Respiratory Care Center standards, able to undergo spontaneous breathing training during the day
Disqualifiers
Recent surgery, anesthesia, or sedative use affecting consciousness
Severe unstable vital signs or inability to breathe normally
Upper airway obstruction or vocal cord paralysis
High dependence on ventilators or high-concentration oxygen therapy
Trial design
Design model
Parallel
Treatments tested in this trial
Passy-Muir Speaking Valve
DeviceThis intervention group receives early speaking valve intervention during ventilator weaning.
Standard Non-Verbal Communication Methods
BehavioralThis control group continues using conventional non-verbal communication methods such as gestures and lip-reading.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Experimental Group (Speaking Valve Intervention)Experimental treatment 1 intervention
Group B: Control Group (Standard Non-Verbal Communication)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Communication Ability (Measured using the Communication Difficulty Scale)
Communication ability will be assessed using the Communication Difficulty Scale (CDS), a validated instrument comprising 13 items designed to measure speech effectiveness in tracheostomy patients. Each item is rated on a 5-point Likert scale (0-4 per item, total score range: 0-52 points), where higher scores indicate greater communication difficulty. Assessments will be conducted at baseline (T0), week 1 (T1), week 2 (T2), and week 4 (T3). Statistical analysis will evaluate changes in communication ability over time using generalized estimating equations (GEE), accounting for intra-subject variability and adjusting for potential confounders such as age, underlying respiratory condition, and baseline cognitive function.
Time frame
From enrollment to 4 weeks post-enrollment2
Depression (Measured using the Patient Health Questionnaire-9, PHQ-9)
Depression symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9), a validated screening tool widely used in clinical and research settings. The PHQ-9 consists of 9 items, each rated on a 4-point Likert scale (0-3 per item, total score range: 0-27 points), where higher scores indicate greater depressive symptoms. Assessments will be conducted at baseline (T0), week 1 (T1), week 2 (T2), and week 4 (T3). Statistical analysis will evaluate changes in depression scores over time using generalized estimating equations (GEE), adjusting for potential confounders such as age, baseline respiratory function, and pre-existing mental health conditions.
Time frame
From enrollment to 4 weeks post-enrollmentLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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