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

NCT ID: NCT07005596

Last Updated: 2025-06-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-15
• Study Completion Date: 2027-12-31

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.

Conditions

Respiratory Failure; Communication Disorders; Depression; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Experimental Group (Speaking Valve Intervention)

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

Group Type: EXPERIMENTAL

Passy-Muir Speaking Valve

Intervention Type: DEVICE

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

Control Group (Standard Non-Verbal Communication)

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.

Group Type: ACTIVE_COMPARATOR

Standard Non-Verbal Communication Methods

Intervention Type: BEHAVIORAL

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

Interventions

Passy-Muir Speaking Valve

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

Intervention Type: DEVICE

Standard Non-Verbal Communication Methods

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

Intervention Type: BEHAVIORAL

Other Intervention Names

Experimental Group; Control Group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Far Eastern Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

CHIA CHI HSU

Role: CONTACT

jiaqi92058@gmail.com

+8860960606032

Other Identifiers

114015-F

Identifier Type: -

Identifier Source: org_study_id