Not Yet RecruitingNot Applicable

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

70 participantsStarted 2025-06-15

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Communication Ability (Measured using the Communication Difficulty Scale)

Timeframe: From enrollment to 4 weeks post-enrollment

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

Timeframe: From enrollment to 4 weeks post-enrollment

Trial details

NCT IDNCT07005596

SponsorFar Eastern Memorial Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-31

Contact for this trial

CHIA CHI HSU

+8860960606032 jiaqi92058@gmail.com

View on ClinicalTrials.gov More Respiratory Failure trials