Clinical trial NCT04511390: Transparent Elastomeric Respirator for Aerosol-based Protection
Official title: Transparent Elastomeric Respirator to Protect Against Aerosol Transmission of Infectious Agents
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Personal Protective Equipment
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
name: Memorial Sloan Kettering Cancer Center
First posted: 2020-08-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Facial hair

Primary outcomes:
measure: Success of fit testing
timeFrame: 30 minutes
Secondary outcomes:
measure: User experience
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
References: