Early Speaking Valve in Ventilator Weaning: Effects on Communication, Depression, and Quality of Life
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Passy-Muir Speaking Valve, Standard Non-Verbal Communication Methods.
- Кому может быть актуально
- Состояния в реестре: Respiratory Failure, Communication Disorders, Depression, Quality of Life. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Список центров уточняется — проверьте первичный протокол.
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Assessing the Impact of Early Tracheostomy Speaking Valve Intervention on Communication, Depression, and Quality of Life in Long-term Ventilator-dependent Patients During the Weaning Phase
Обзор
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.
Подробное описание
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.
Вмешательства
- Устройство Passy-Muir Speaking Valve
This intervention group receives early speaking valve intervention during ventilator weaning. - Поведенческое Standard Non-Verbal Communication Methods
This control group continues using conventional non-verbal communication methods such as gestures and lip-reading.
Первичные конечные точки
- Communication Ability (Measured using the Communication Difficulty Scale) [Срок оценки: From enrollment to 4 weeks post-enrollment]
- Depression (Measured using the Patient Health Questionnaire-9, PHQ-9) [Срок оценки: From enrollment to 4 weeks post-enrollment]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Поддерживающая терапия
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT07005596 · 114015-F