NCT00942903已完成1 期
Phase 1 Study. Short-term Feasibility of the Next Generation Provox HMEs for Pulmonary Rehabilitation After Total Laryngectomy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Patient Preference for Provox HME or Provox XtraHME
研究概览
简要总结
This study is a short term feasibility study that aims to investigate patient satisfaction with and performance of new Provox Xtra HME in 20 laryngectomized patients. Aspects that are considered are for example performance for stoma occlusion, speaking, breathing, appearance, compliance, and short-term impact on pulmonary symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •total laryngectomy
- •compliant Provox HME user (24/7 use)
排除标准
- •current medical problems that might influence HME use
结局指标
主要结局
Patient Preference for Provox HME or Provox XtraHME
时间窗: 3 weeks
the patient preference is based on a structured questionnaire on several aspects regarding the use of the new Provox XtraHME in comparison with the Provox HME.
次要结局
- Noise at Stoma Occlusion(3 weeks)
研究者
研究点 (2)
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