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Transparent Elastomeric Respirator for Aerosol-based Protection

Transparent Elastomeric Respirator to Protect Against Aerosol Transmission of Infectious Agents

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04511390
Enrollment
100
Registered
2020-08-13
Start date
2020-07-25
Completion date
2022-02-28
Last updated
2021-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Personal Protective Equipment

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.

Interventions

DEVICETransparent, reusable respirator

A novel respirator with dual N95 filter cartridges

Sponsors

Massachusetts General Hospital
CollaboratorOTHER
Memorial Sloan Kettering Cancer Center
CollaboratorOTHER
Brigham and Women's Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* Facial hair

Design outcomes

Primary

MeasureTime frameDescription
Success of fit testing30 minutesSuccessful fit testing using an Occupational Safety and Health Administration (OSHA)-approved testing method testing method

Secondary

MeasureTime frameDescription
User experience30 minutesUser experience with fit, breathability and filter replacement will be assessed based on a Likert scale through a post-fit test questionnaire

Countries

United States

Contacts

Primary ContactGiovanni Traverso, MB, BChir, PhD
cgt20@mit.edu617-253-5726

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026