Transparent Elastomeric Respirator for Aerosol-based Protection

Personal Protective Equipment Clinical Trial

Official title:

Transparent Elastomeric Respirator to Protect Against Aerosol Transmission of Infectious Agents

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04511390
• Other study ID #: 2020P000852
• Status: Recruiting
• Phase: N/A
• Start date: July 25, 2020
• Est. completion date: February 28, 2022

Study information

• Verified date: August 2021
• Source: Brigham and Women's Hospital
• Contact: Giovanni Traverso, MB, BChir, PhD
• Phone: 617-253-5726
• Email: cgt20[@]mit.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 28, 2022
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Facial hair

Related Conditions & MeSH terms

• Personal Protective Equipment

Intervention

Device:
• Transparent, reusable respirator
A novel respirator with dual N95 filter cartridges

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Massachusetts General Hospital, Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success of fit testing	Successful fit testing using an Occupational Safety and Health Administration (OSHA)-approved testing method testing method	30 minutes
Secondary	User experience	User experience with fit, breathability and filter replacement will be assessed based on a Likert scale through a post-fit test questionnaire	30 minutes