Clinical trial NCT07005596: Early Speaking Valve in Ventilator Weaning: Effects on Communication, Depression, and Quality of Life
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Respiratory Failure
Communication Disorders
Depression
Quality of Life
Keywords: speaking valve
tracheostomy
communication
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2025-06-05
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study uses a parallel assignment design where participants are randomly allocated into either an intervention group receiving Passy-Muir speaking valves or a control group using conventional non-verbal communication methods. The effectiveness of the intervention is assessed through structured questionnaires measuring communication ability, depression levels, and quality of life over multiple time points. Data collectors remain blinded to group assignments to reduce bias in outcome assessments.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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

Primary outcomes:
measure: Communication Ability (Measured using the Communication Difficulty Scale)
timeFrame: From enrollment to 4 weeks post-enrollment
measure: Depression (Measured using the Patient Health Questionnaire-9, PHQ-9)
timeFrame: From enrollment to 4 weeks post-enrollment
Secondary outcomes:
Other outcomes:
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