Early Speaking Valve in Ventilator Weaning: Effects on Communication, Depression, and Quality of Life
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Passy-Muir Speaking Valve, Standard Non-Verbal Communication Methods.
- Who it may be relevant to
- Registry conditions: Respiratory Failure, Communication Disorders, Depression, Quality of Life. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Assessing the Impact of Early Tracheostomy Speaking Valve Intervention on Communication, Depression, and Quality of Life in Long-term Ventilator-dependent Patients During the Weaning Phase
Overview
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.
Detailed description
This randomized controlled trial investigates the effects of early intervention using the Passy-Muir speaking valve on communication, depression, and quality of life in tracheostomy patients undergoing ventilator weaning. The study will enroll 70 participants from the respiratory care center at Far Eastern Memorial Hospital, randomly assigned to either the experimental group (speaking valve intervention) or the control group (standard non-verbal communication methods). Data will be collected using validated assessment tools at baseline, week 1, week 2, and week 4. The primary outcomes include improvements in patient communication, reduction in depressive symptoms, and enhancement of overall quality of life. Statistical analysis will be conducted using SPSS 22.0, employing t-tests, chi-square tests, and generalized estimating equations (GEE). Ethical considerations include informed consent, patient confidentiality, and adherence to IRB-approved protocols. Findings from this study will contribute to evidence-based practices for tracheostomy patient care and guide clinical decision-making on communication strategies during ventilator weaning.
Interventions
- Device Passy-Muir Speaking Valve
This intervention group receives early speaking valve intervention during ventilator weaning. - Behavioral Standard Non-Verbal Communication Methods
This control group continues using conventional non-verbal communication methods such as gestures and lip-reading.
Primary outcome measures
- Communication Ability (Measured using the Communication Difficulty Scale) [Time frame: From enrollment to 4 weeks post-enrollment]
- Depression (Measured using the Patient Health Questionnaire-9, PHQ-9) [Time frame: From enrollment to 4 weeks post-enrollment]
Eligibility criteria
Inclusion criteria
- 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
- Ventilator Settings: FiO2 ≤40%
- Vital Signs: Stable:
- Heart rate 60-100 beats/min
- Respiratory rate 12-20 breaths/min
- Systolic blood pressure <150 mmHg, diastolic blood pressure <90 mmHg
- Blood oxygen saturation 95-100%, no dyspnea complaints
- Richmond Agitation-Sedation Scale (RASS) between -1 and +1
- Language: Able to communicate in Mandarin, Taiwanese, or Hakka
- Consent: Willing to participate in the study
Exclusion criteria
- 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
- History of depression or currently taking antidepressant medication
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07005596 · 114015-F