Early Speaking Valve in Ventilator Weaning: Effects on Communication, Depression, and Quality of Life

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Respiratory Failure Behavior Behavioral Symptoms Communication Communication Disorders Depression Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Quality of Life Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Passy-Muir Speaking Valve

Device

This intervention group receives early speaking valve intervention during ventilator weaning.

Other names: Experimental Group

Standard Non-Verbal Communication Methods

Behavioral

This control group continues using conventional non-verbal communication methods such as gestures and lip-reading.

Other names: Control Group

Primary outcomes

Communication Ability (Measured using the Communication Difficulty Scale)

Time frame: From enrollment to 4 weeks post-enrollment

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.
Depression (Measured using the Patient Health Questionnaire-9, PHQ-9)

Time frame: From enrollment to 4 weeks post-enrollment

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.

Study contacts

Contact information is provided by the study sponsor or research team.

CHIA CHI HSU

CONTACT

[email protected]

+8860960606032

Sponsors and collaborators

Lead sponsor

Far Eastern Memorial Hospital

Other

Registry information

Official study 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

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: Jun 5, 2025
Registry last updated: Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed