NCT06084611已完成不适用
Long Term Effects of Heat and Moisture Exchangers (HMEs) (Provox® Life™) on Pulmonary Symptoms in Laryngectomized Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- CASA-Q Score
研究概览
简要总结
Assessment of long term effect of Provox Life HME use on pulmonary symptoms in laryngectomized patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Total laryngectomy, irrespective of pharynx reconstruction method
- •18 years or older
- •Longer than 3 months after total laryngectomy
- •Longer than 6 weeks after postoperative radiotherapy
排除标准
- •Current use of HMEs (within last 3 months)
- •Medical problems prohibiting the use of HME
- •Active recurrent or metastatic disease (medical deterioration)
- •Recent pulmonary infections/unstable pulmonary condition
- •Insufficient physical, cognitive, or mental ability required to attach, remove or operate the devices themselves
- •Low tidal volumes
- •Unable to understand the Participant Information and/or unable to give Informed Consent
结局指标
主要结局
CASA-Q Score
时间窗: Baseline, 3 months, 6 months, 9 months
assessed with validated Coughing and Sputum Assessment Questionnaire (CASA-Q). Score between 0 and 100, with higher scores meaning less symptoms and less impact.
次要结局
- Quality of Life by EQ-5D-5L(Baseline, 3 months, 6 months, 9 months)
- Jenkins sleep evaluation questionnaire(Baseline, 3 months, 6 months, 9 months)
- Number of involuntary coughs per 24 hours(Baseline, 3 months, 6 months, 9 months)
- Forced Expectoration(Baseline, 3 months, 6 months, 9 months)
- Study-specific questionnaire to assess number of complications and medical treatments(Baseline, 3 months, 6 months, 9 months)
- Questionnaire to assess Shortness of Breath(Baseline, 3 months, 6 months, 9 months)
- Voice handicap Index(Baseline, 3 months, 6 months, 9 months)
- Consumption of medical devices (Number of devices used)(Baseline, 3 months, 6 months, 9 months)
研究者
研究点 (1)
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