A Proposed Alternative to the N-95 Mask Shortage in the COVID-19 Pandemic. A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Success Percentage
研究概览
简要总结
The purpose of this study is to assess the safety and efficiency of an assembled modified mask in protecting health care workers against Coronavirus in case of any personal protective equipment shortage. At least 20 healthy participants will be recruited to try the modified mask. The modified masks will be made from masks that are already available as well as filters available in the pulmonary department at the Oklahoma City VA Health Care System
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All individuals older than 18 years of age, and willing to participate in the study
排除标准
- •Individuals with known severe COPD/emphysema, Obesity Hypoventilation or hypercapnic condition
- •Individuals with allergy or reactions to latex or masks
- •Individuals reporting dyspnea or unable to breathe comfortably in these masks
- •Claustrophobic individuals
- •Inability to create a proper Seal while inhaling through a closed filter (See Below)
- •Individuals who cannot safely apply and remove these masks
研究组 & 干预措施
Assembled Mask
Participant will be fitted with a full-face mask that covers the mouth and nose or a Whole face mask that covers the eyes, nose, and mouth depending on participant's preferences. The Fitted Mask will be attached to a bacterial/viral filter for fit testing. After completing the Fit test, the mask will be placed on the face for 15 minutes while the participant performs various activities to document the ability to tolerate the respirator. Participants oxygen and carbon dioxide level will be measured in the beginning and at the end of the 15 minutes. The individuals will be able to remove the Mask anytime if they experience significant discomfort or claustrophobia. At the end, the mask will be removed.
干预措施: Assembled mask (Other)
结局指标
主要结局
Success Percentage
时间窗: 15 minutes
Conduct a quantitative fit test and calculate the percentage of participants who pass the test.
次要结局
- End-tidal CO2 Variation. Description: mmHg.(at 0 and 15 minutes)
- Mask Visibility. Description: Likert Scale.(15 minutes)
- Willingness of usage. Description: Likert Scale.(after 15 minutes)
- Oxygen Pulse Oximetry Variation. Description: mmHg.(at 0 and 15 minutes.)