NCT02224612已完成4 期
A Comparative Evaluation of the Performance and Fit of Pediatric Face Masks
Medline Industries2 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2014年1月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Change From Baseline in Carbon Dioxide Levels
研究概览
简要总结
Compare the fit of two pediatric face masks in children.
详细描述
This is a prospective, randomized, open-label comparative observational study to be conducted in up to two (2) facilities with the healthy and non-healthy Subjects (4-12 years of age). The usage of face masks is common practice within hospitals, and masks may be evaluated outside of clinical facilities as well.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •4 to 12 years of age
- •conscious
排除标准
- •able to wear a mask
- •no previous allergic reactions to face masks
结局指标
主要结局
Change From Baseline in Carbon Dioxide Levels
时间窗: Baseline and 2 minutes
ETCO2 will be assessed by a capnographer when wearing each pediatric face mask. Results are the difference between masks in change from baseline.
次要结局
- Physical Fit of Pediatric Face Masks.(Immediate)
研究者
研究点 (2)
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