A Comparative Evaluation of the Performance and Fit of Pediatric Face Masks
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
- 1
- 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
研究组 & 干预措施
Children 4-5 yrs
Medline Pediatric Face Mask KC Childs Face Mask
Comparison of Medline Pediatric Face Masks and KC Childs Mask which are both single use disposable masks. Each mask (two in total) were worn for 2-3 minutes for EtCO2 and respiration assessments and physical fit assessment.
干预措施: KC Childs Mask (Device)
Children 4-5 yrs
Medline Pediatric Face Mask KC Childs Face Mask
Comparison of Medline Pediatric Face Masks and KC Childs Mask which are both single use disposable masks. Each mask (two in total) were worn for 2-3 minutes for EtCO2 and respiration assessments and physical fit assessment.
干预措施: Medline Pediatric Face Masks (Device)
Children 6-9 yrs
Medline Pediatric Face Mask KC Childs Face Mask
Comparison of Medline Pediatric Face Masks and KC Childs Mask which are both single use disposable masks. Each mask (two in total) were worn for 2-3 minutes for EtCO2 and respiration assessments and physical fit assessment.
干预措施: Medline Pediatric Face Masks (Device)
Children 6-9 yrs
Medline Pediatric Face Mask KC Childs Face Mask
Comparison of Medline Pediatric Face Masks and KC Childs Mask which are both single use disposable masks. Each mask (two in total) were worn for 2-3 minutes for EtCO2 and respiration assessments and physical fit assessment.
干预措施: KC Childs Mask (Device)
Children 10-12 yrs
Medline Pediatric Face Mask KC Childs Face Mask
Comparison of Medline Pediatric Face Masks and KC Childs Mask which are both single use disposable masks. Each mask (two in total) were worn for 2-3 minutes for EtCO2 and respiration assessments and physical fit assessment.
干预措施: Medline Pediatric Face Masks (Device)
Children 10-12 yrs
Medline Pediatric Face Mask KC Childs Face Mask
Comparison of Medline Pediatric Face Masks and KC Childs Mask which are both single use disposable masks. Each mask (two in total) were worn for 2-3 minutes for EtCO2 and respiration assessments and physical fit assessment.
干预措施: KC Childs Mask (Device)
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)