Early Speaking Valve in Ventilator Weaning: Effects on Communication, Depression, and Quality of Life
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFar Eastern Memorial Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Passy-Muir Speaking Valve
- Standard Non-Verbal Communication Methods
Treatment groups
70 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov