Transparent Elastomeric Respirator for Aerosol-based Protection

Transparent Elastomeric Respirator to Protect Against Aerosol Transmission of Infectious Agents

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.

Study Overview

• Status: Recruiting
• Conditions: Personal Protective Equipment
• Intervention / Treatment: Device: Transparent, reusable respirator

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Giovanni Traverso, MB, BChir, PhD; Phone Number: 617-253-5726; Email: cgt20@mit.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham and Women's Hospital
      • Contact: Giovanni Traverso, MB, BChir, PhD; Phone Number: 617-253-5726; Email: cgt20@mit.edu
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Manish Gala, MD; Phone Number: 617-724-6004; Email: mgala@mgh.harvard.edu
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center
      • Contact: Paul Zel; Phone Number: 212-639-2000; Email: zelp@MSKCC.ORG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Facial hair

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success of fit testing	Successful fit testing using an Occupational Safety and Health Administration (OSHA)-approved testing method testing method	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: Memorial Sloan Kettering Cancer Center; Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2020
• Primary Completion (Anticipated): December 30, 2021
• Study Completion (Anticipated): February 28, 2022

Study Registration Dates

• First Submitted: August 10, 2020
• First Submitted That Met QC Criteria: August 11, 2020
• First Posted (Actual): August 13, 2020

Study Record Updates

• Last Update Posted (Actual): August 4, 2021
• Last Update Submitted That Met QC Criteria: August 2, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2020P000852

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No