Recruiting

Observational Study

Sponsor:

Brigham and Women's Hospital

Code:

NCT04511390

Conditions

Personal Protective Equipment

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Transparent, reusable respirator

Study Details

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.

Conditions

Personal Protective Equipment

Study ID

NCT04511390

Start date

Jul 25, 2020

Status verified date

Aug, 2021

Completion date

Feb 28, 2022

Anticipated

Primary completion date

Dec 30, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • Facial hair

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Transparent, reusable respirator

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

Interventions

Transparent, reusable respirator

A novel respirator with dual N95 filter cartridges

Primary outcome measure

  • Success of fit testing [ Time Frame: 30 minutes ]

Central Contacts and Locations

Central contacts

Giovanni Traverso, MB, BChir, PhD

617-253-5726cgt20@mit.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Manish Gala, MD

617-724-6004mgala@mgh.harvard.edu

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Giovanni Traverso, MB, BChir, PhD

617-253-5726cgt20@mit.edu

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Paul Zel

212-639-2000zelp@MSKCC.ORG

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Aug 4, 2021

Last verified

Aug, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2021-08-04.