Transparent Elastomeric Respirator for Aerosol-based Protection

Sponsor

Brigham and Women's Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04511390

Collaborator

Massachusetts General Hospital (Other), Memorial Sloan Kettering Cancer Center (Other)

100

Enrollment

Locations

Arm

19.2

Anticipated Duration (Months)

33.3

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Personal Protective Equipment	Device: Transparent, reusable respirator	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Transparent Elastomeric Respirator to Protect Against Aerosol Transmission of Infectious Agents

Actual Study Start Date :

Jul 25, 2020

Anticipated Primary Completion Date :

Dec 30, 2021

Anticipated Study Completion Date :

Feb 28, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Transparent, reusable respirator Transparent, reusable elastomeric respirator that has been designed to fit multiple different face sizes and shapes.	Device: Transparent, reusable respirator A novel respirator with dual N95 filter cartridges

Arm

Intervention/Treatment

Experimental: Transparent, reusable respirator

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

Device: Transparent, reusable respirator

A novel respirator with dual N95 filter cartridges

Outcome Measures

Primary Outcome Measures

Success of fit testing [30 minutes]
Successful fit testing using an Occupational Safety and Health Administration (OSHA)-approved testing method testing method

Secondary Outcome Measures

User experience [30 minutes]
User experience with fit, breathability and filter replacement will be assessed based on a Likert scale through a post-fit test questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
2	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
3	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

C. Giovanni Traverso MB Bchir PhD, Assistant Professor, Brigham and Women's Hospital

ClinicalTrials.gov Identifier:

NCT04511390

Other Study ID Numbers:

2020P000852

First Posted:

Aug 13, 2020

Last Update Posted:

Aug 4, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Study Results

No Results Posted as of Aug 4, 2021