ClinConnect ClinConnect Logo
Search / Trial NCT07005596

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

Launched by FAR EASTERN MEMORIAL HOSPITAL · Jun 4, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Speaking Valve Tracheostomy Communication

ClinConnect Summary

This clinical trial is studying how using a special speaking valve can help patients who are on ventilators communicate better and improve their emotional well-being during the process of getting off the ventilator. The trial will involve two groups: one group will use the Passy-Muir speaking valve, which allows for speech, while the other group will use standard methods that do not involve speaking. Researchers will ask participants questions at different times to see how their ability to communicate, their feelings of depression, and their overall quality of life change throughout this process.

To be eligible for the trial, participants must be at least 18 years old and able to respond to questions, meaning they have a good level of alertness. They should have had a tracheostomy (a procedure to help with breathing) for at least 24 hours and be stable enough to participate in training for breathing on their own. They also need to be able to communicate in Mandarin, Taiwanese, or Hakka. If you or someone you know is interested in this trial, it could be a valuable way to explore new ways to improve communication and emotional health for those who rely on ventilators. The trial is not yet recruiting participants, but it aims to provide important insights into better care strategies for these patients.

Gender

ALL

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

About Far Eastern Memorial Hospital

Far Eastern Memorial Hospital is a leading healthcare institution in Taiwan, renowned for its commitment to advancing medical research and improving patient care through innovative clinical trials. With a focus on multidisciplinary collaboration, the hospital integrates cutting-edge technology and evidence-based practices to conduct rigorous clinical studies across various therapeutic areas. Far Eastern Memorial Hospital prioritizes patient safety and ethical standards, ensuring that all trials are designed to enhance medical knowledge and contribute to the development of new treatments. Its experienced team of researchers and healthcare professionals is dedicated to fostering a research environment that supports scientific discovery and enhances health outcomes for diverse patient populations.

Locations

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported