Ignite Creation Date:
2024-05-06 @ 3:04 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04511390
Status:
UNKNOWN
Last Update Posted:
2021-08-04
First Post:
2020-08-10
Brief Title:
Transparent Elastomeric Respirator for Aerosol-based Protection
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
Transparent Elastomeric Respirator to Protect Against Aerosol Transmission of Infectious Agents
Status:
UNKNOWN
Status Verified Date:
2021-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None