End-tidal Carbon Dioxide Measurements in Adults and Children Wearing Surgical Masks
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 119
- 试验地点
- 2
- 主要终点
- Potential Change in End Tidal CO2 level
研究概览
简要总结
An Interventional Study is planned with the primary purpose of screening for changes in end-tidal carbon dioxide (ETCO2), inspired carbon dioxide (ICO2), and other vital signs that may develop after donning a disposable surgical mask.
Measurements will be taken and recorded during a 5-minute control period without a mask, recording non-invasive ETCO2 and ICO2 levels by way of a nasal cannula (NC), oxygen saturation (SpO2), breaths per minute (RR), and heart rate (HR) via anesthesia equipment. This will be followed by a 15-minute intervention of wearing a disposable surgical mask and repeating measurements of ETCO2, ICO2, SpO2, RR, and HR, recorded each minute.
Data will be collected from adults and children as young as 2 years of age. Age groups will include children aged 2-14 and adults aged 18 to 80, as described in the details of the research protocol. Parents and their children are invited to participate together.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Good health
- •Aged 2 - 14 years (inclusive) or 18 - 80 years (inclusive)
排除标准
- •Significant cardiopulmonary diseases
- •Intolerance to wearing nasal canula
- •Intolerance to wearing a surgical mask
结局指标
主要结局
Potential Change in End Tidal CO2 level
时间窗: End tidal CO2 levels after 5 minutes without a mask will be compared to End Tidal CO2 levels after 15 minutes wearing a disposable surgical mask
measurement of End Tidal CO2 by way of nasal cannula
次要结局
- Potential change in Inspired CO2 level(Inspired CO2 levels after 5 minutes without a mask will be compared to Inspired CO2 levels after 15 minutes wearing a disposable surgical mask)
- Potential change in respiratory rate measured in breaths per minute(Respiratory rate after 5 minutes without a mask will be compared to respiratory rate after 15 minutes wearing a disposable surgical mask)
- Potential change in oxygen saturation(Oxygen saturation levels after 5 minutes without a mask will be compared to oxygen saturation levels after 15 minutes wearing a disposable surgical mask)
- Potential change in Heart Rate(Heart rate after 5 minutes without a mask will be compared to heart rate after 15 minutes wearing a disposable surgical mask)
研究者
Patrick Brooks
Assistant Professor
Missouri State University