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

NCT07005596 | Not Yet Recruiting

• 1 other identifier: 114015-F
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Respiratory Failure; Communication Disorders; Depression; Quality of Life

Keywords

speaking valve; tracheostomy; communication

Outcome Measures

Primary Outcomes (2)

• 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.

  From enrollment to 4 weeks post-enrollment

• 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.

  From enrollment to 4 weeks post-enrollment

Study Arms (2)

Experimental Group (Speaking Valve Intervention)

EXPERIMENTAL

Participants in the experimental group will receive early intervention using the Passy-Muir speaking valve while undergoing ventilator weaning. This intervention aims to improve communication ability, reduce depression levels, and enhance quality of life. The intervention will be implemented at four different time points (Baseline, Week 1, Week 2, Week 4), with structured assessments for effectiveness

Device: Passy-Muir Speaking Valve

Control Group (Standard Non-Verbal Communication)

ACTIVE COMPARATOR

Participants in the control group will continue using standard non-verbal communication methods, such as lip-reading and gestures, during ventilator weaning. This group serves as a comparison to assess the effectiveness of early speaking valve intervention in tracheostomy patients.

Behavioral: Standard Non-Verbal Communication Methods

Interventions

Passy-Muir Speaking Valve DEVICE

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

Also known as: Experimental Group

Experimental Group (Speaking Valve Intervention)

Standard Non-Verbal Communication Methods BEHAVIORAL

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

Also known as: Control Group

Control Group (Standard Non-Verbal Communication)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Far Eastern Memorial Hospital: lead

MeSH Terms

Conditions

Respiratory Insufficiency; Communication Disorders; Depression; Communication

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

CHIA CHI HSU

CONTACT

+8860960606032; jiaqi92058@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: June 5, 2025
• Study Start: June 15, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share