跳至主要内容
临床试验/NCT04511390
NCT04511390Unknown不适用

Transparent Elastomeric Respirator to Protect Against Aerosol Transmission of Infectious Agents

Brigham and Women's Hospital3 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年7月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
100
试验地点
3
主要终点
Success of fit testing

研究概览

简要总结

In times of crisis, diminishing supplies of personal protective equipment (PPE) in hospitals has forced both healthcare workers and the general population to reuse and clean PPE using anecdotal strategies which may weaken its effectiveness of preventing acquisition of airborne respiratory illnesses, such as COVID-19. There is therefore a great need to develop innovative measures to generate reusable PPE that can be safely cleaned and sterilized. A novel reusable injection molded respirator will be evaluated using qualitative and quantitative fit tests to assess overall fit and comfort.

详细描述

PPE is the last line of defense in the hierarchy of controls to prevent the spread of airborne transmissible infections. There are many varieties of respirators including quarter-mask, half mask, and full facepiece respirators that filter 95, 99, or 100% of airborne particles. The elastomeric half mask respirators (EHMRs), in particular, have several advantages over commonly used N95 FFRs. Firstly, EHMRs may be cleaned, disinfected, and reused unlike FFRs that are normally discarded after a single use. EHMRs may be transparent as a result of material choice and will allow for visualization of the mouth. Lastly, they have been shown to properly fit faces after multiple rounds of decontamination.

Some disadvantages of EHMRs include the requirement to disinfect and reinspect the quality of components on the respirator by a qualified individual for proper function, as well as manual exchange of filter components. Notwithstanding, it has been found that fit testing and training to use EHMRs for healthcare personnel is not significantly different than N95 respirators and that EHMR may serve as a suitable alternative to disposable N95 respirators during public health emergencies. Furthermore, a 2018 consensus report from the National Academies of Engineering, Science, and Medicine recommended that the durability and reusability of elastomeric respirators made them desirable for stockpiling for emergencies.

A new transparent elastomeric respirator has been developed that can maintain respirator integrity after decontamination and fits many people with different face sizes and shapes. Fit testing of the respirator will be performed using an OSHA-approved testing method.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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

  • •Healthcare workers that have undergone successful fit test with N95 FFR within 1 year of the trial

排除标准

  • •Facial hair

研究组 & 干预措施

Transparent, reusable respirator

Experimental

Transparent, reusable elastomeric respirator that has been designed to fit multiple different face sizes and shapes.

干预措施: Transparent, reusable respirator (Device)

结局指标

主要结局

Success of fit testing

时间窗: 30 minutes

Successful fit testing using an Occupational Safety and Health Administration (OSHA)-approved testing method testing method

次要结局

  • User experience(30 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

C. Giovanni Traverso MB Bchir PhD

Assistant Professor

Brigham and Women's Hospital

研究点 (3)

Loading locations...

相似试验