热湿交换器的 ProvoxLife 采用趋势
热湿交换器 (HME) 的 ProvoxLife® 采用趋势：PATH 注册表
This study examines factors that affect how often patients who have a total laryngectomy use a ProvoxLife heat-moisture exchanger (HME) system to help improve their lung function. ProvoxLife HMEs are single use heat- and moisture exchangers for patients breathing through a tracheostoma. Information from this study may help doctors learn more about factors associated with patterns of use and how often patients use the ProvoxLife HME system.
研究概览
地位
条件
详细说明
PRIMARY OBJECTIVE:
I. To determine clinical and patient factors associated with patterns of use of the ProvoxLife HME system for pulmonary rehabilitation after total laryngectomy.
SECONDARY OBJECTIVES:
I. To explore outcomes associated with patterns of ProvoxLife HME system. II. To explore factors associated with post-laryngectomy outcomes.
OUTLINE:
Patients undergo speech and swallow evaluation by speech pathologist or study staff member and examination of tracheoesophageal puncture (TEP) and laryngectomy stoma. Patients also complete questionnaires over 30 minutes about use the ProvoxLife HME system, symptoms, ability to communicate, exercise and physical activity levels, and quality of life at baseline and 3 months post-ProvoxLife.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Texas
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Houston、Texas、美国、77030
- M D Anderson Cancer Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Patients using or planning to use HME as part of standard care
描述
Inclusion Criteria:
- Adults >= 18 years of age planned for or status post total laryngectomy
- Using or ready for fit of HME system
Exclusion Criteria:
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Active malignancy if post-total laryngectomy (TL) at the time of enrollment
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Unable to complete questionnaires in English language
- The primary endpoint derives from a study specific questionnaire, due to limited resources, is only available in English language
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Cognitive or other limitations that preclude independent self-care or completion of questionnaires
- Cognitive or other limitations that preclude independent self-care or completion of questionnaires will be assessed in the screening interview by the clinical or research team
学习计划
研究是如何设计的？
设计细节
- 观测模型：COHORT
- 时间观点：PROSPECTIVE
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Observational (evaluation, examination, questionnaire)
Patients undergo speech and swallow evaluation by speech pathologist or study staff member and examination of TEP and laryngectomy stoma. Patients also complete questionnaires over 30 minutes about use the ProvoxLife HME system, symptoms, ability to communicate, exercise and physical activity levels, and quality of life at baseline and 3 months post-ProvoxLife. |
Complete questionnaires Undergo speech and swallow evaluation
其他名称：
Undergo examination of TEP and laryngectomy stoma
其他名称：
Complete questionnaires
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
确定与全喉切除术后使用 ProvoxLife HME 系统进行肺康复的模式相关的临床和患者因素。
大体时间：ProvoxLife HME 后最多 3 个月
|
ProvoxLife HME 后最多 3 个月
|
合作者和调查者
调查人员
- 首席研究员：Katherine A Hutcheson、M.D. Anderson Cancer Center
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.