Clinical trial NCT04826809: New Reusable Mask Design With Superior Filtration and Fit
Official title: A New Fully-reusable, Affordable, Comfortable Mask Design With Superior Filtration and Fit for Use During Respirator Shortages and Pandemics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Tuberculosis
Respiratory Viral Infection
Keywords: PPE
mask
N95
pandemic
mask shortage
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study will test the filtration, air leak, and breathability of a newly designed fully washable mask developed by Dr. Nordell with the Mayo Clinic. This mask is theorized to be a superior alternative to other respirators currently used when one-time-use N95 masks are unavailable.

Detailed description: The purpose of this study is to determine potential effectiveness of a new, reusable mask against SARS-CoV-2 and other microbes. This requires filtering down to at least 0.3 microns, as the SARS-CoV-2 virus is on average 0.25-0.5 microns in diameter.

Dr. Nordell has developed a machine-washable mask which shows potential to be significantly more effective than other masks on the market. It uses a fabric that is machine washable, without need for a filter or replaceable component. This fabric, Evolon-100 or E-100, is a microfilament fabric produced by a private company outside of the USA (and is therefore not yet FDA approved as of December 2020).

Unofficial data shows this mask passes the "N95 fit test" before and after multiple washes on the majority of individuals tested, and the material used in Dr. Nordell's design filters 93-96% of 0.3 micron particles. For reference, the N95 mask used in the hospital (whenever concern for potential exposure to COVID-19 or similar contagion exists) filters 95% of 0.3 micron particles when factoring in air leak, assessed with the "fit test." Voluntary survey of users also shows it is more comfortable than other masks, including the N95. This mask is also reported to be breathable even after prolonged use.

This mask design addresses every factor in respirator design. The design intentionally uses pleats to increase the effective mask surface area while decreasing the seal perimeter, resulting in increased air flow, lower pressure drop, and increased filtration efficiency. The investigators propose that it has a higher filtration ability than other washable fabrics tested, filtering at least 93% of 0.3 micron particles, even up to 96%. It also helps prevent air leak, a large factor limiting efficacy of most non-standard masks. It is easy to don and doff, and it is very easy to clean and disinfect. This material can be washed multiple times in a standard washing machine without reducing its effectiveness. And finally, it is very affordable, with materials for one mask costing less than $1.50. All materials used beyond this specific fabric are easily purchased on the internet or in a fabric store.

Upon completion of this research, the investigators hope to demonstrate that this mask is a superior alternative in multiple settings, including hospitals in developing countries with little or no N95 mask access, non-hospital settings such as businesses and schools, as well as for the general population, especially those with high risk for COVID-related complications.

Eligibility criteria: Inclusion Criteria:

* Current employee of Mayo Clinic Health System-Mankato
* Passed N95 fit test within the past year
* No medical history of: high blood pressure, current or recent pneumonia or upper respiratory infection, and no uncontrolled chronic asthma
* Ideally with wide representation of genders, race, age, BMI, occupation/role in hospital.
* Willing and able to provde verbal consent.

Exclusion Criteria:

- History of uncontrolled asthma, pneumonia, or hypertension.

Primary outcomes:
measure: Comparison of Fit Tests
timeFrame: Baseline
measure: Comfort Level of Nordell Double E-100 Layer Mask
timeFrame: Baseline
measure: Ability to Breathe With Nordell Double E-100 Layer Mask
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Mankato
country: United States
facility: Mayo Clinic Health System in Mankato
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Janielle R Nordell, MD
role: PRINCIPAL_INVESTIGATOR
References: