An interventional study of N95 mask and Nordell single E-100 layer mask in Covid19, Tuberculosis and Respiratory Viral Infection, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-07.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Prevention
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.
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.
7,774 studies on the registry are indexed under COVID-19; 482 are open to participants now.
This study's enrollment of 41 is below the median of 100 across 4,175 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Mayo Clinic is the lead sponsor of 3,263 studies on the registry; 670 are open to participants now.
Of its 450 completed or terminated interventional studies of FDA-regulated products, 318 (71%) have results posted.
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Exclusion Criteria:
- History of uncontrolled asthma, pneumonia, or hypertension.
Health care workers will complete a fit test while wearing the Nordell Single E-100 layer + (cotton layer) mask, Nordell Double E-100 layer mask and an N95 mask
Device: N95 mask · Device: Nordell single E-100 layer mask · Device: Nordell double E-100 layer mask
Standard 1870 N95 one time use mask
Nordell mask design using one layer of E-100 fabric plus cotton fabric overlay
Nordell mask design using two layers of E-100 fabric
Comparison of Fit Tests
Number of participants to pass the respirator fit testing using Bitrix solution. If participants do not smell or taste the solution while wearing the respirator it is considered passed.
Time frame: Baseline
Comfort Level of Nordell Double E-100 Layer Mask
Measured by a self-reported questionnaire that rates the comfort level of the Nordell Double E-100 layer mask on a scale from 0 to 5 (0 is the most uncomfortable mask ever worn, 5 is the best, most comfortable mask)
Time frame: Baseline
Ability to Breathe With Nordell Double E-100 Layer Mask
Measured by a self-reported questionnaire that rates ability to breathe comfortably while wearing the Nordell Double E-100 Layer Mask, from 0 (not able to breathe at all) to 5 (just as easy to breathe as not wearing any mask)
Time frame: Baseline
| Milestone | Health Care Workers |
|---|---|
| Started | 41 |
| Completed | 41 |
| Not completed | 0 |
Number of participants to pass the respirator fit testing using Bitrix solution. If participants do not smell or taste the solution while wearing the respirator it is considered passed.
| Participants | Health Care Workers |
|---|---|
| Fit Test N95 | 39 |
| Fit Test Nordell Single Layer Mask | 39 |
| Fit Test Nordell Double Layer Mask | 40 |
Measured by a self-reported questionnaire that rates the comfort level of the Nordell Double E-100 layer mask on a scale from 0 to 5 (0 is the most uncomfortable mask ever worn, 5 is the best, most comfortable mask)
| Participants | Health Care Workers |
|---|---|
| 0 = most uncomfortable | 0 |
| 1 | 1 |
| 2 | 0 |
| 3 | 4 |
| 4 | 22 |
| 5 = most comfortable | 14 |
Measured by a self-reported questionnaire that rates ability to breathe comfortably while wearing the Nordell Double E-100 Layer Mask, from 0 (not able to breathe at all) to 5 (just as easy to breathe as not wearing any mask)
| Participants | Health Care Workers |
|---|---|
| 0 (worst) | 0 |
| 1 | 0 |
| 2 | 1 |
| 3 | 4 |
| 4 | 11 |
| 5 (best) | 25 |
Collected over Adverse events were collected on all subject during participation for approximately 2-3 hours.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Health Care Workers | 0/41 (0%) | 0/41 (0%) | 0/41 (0%) |
| Age, Customized(Participants) | Health Care Workers |
|---|---|
| Between 18 and 29 years | 3 |
| Between 30 and 39 years | 15 |
| Between 40 and 49 years | 11 |
| Between 50 and 59 years | 8 |
| >= 60 years | 4 |
| Sex: Female, Male(Participants) | Health Care Workers |
|---|---|
| Female | 34 |
| Male | 7 |
| Race/Ethnicity, Customized(Participants) | Health Care Workers |
|---|---|
| White, non-Hispanic | 37 |
| Hispanic | 2 |
| Black/African American | 0 |
| Asian/Pacific Islander | 2 |
| American Indian | 0 |
| Other | 0 |
| Region of Enrollment(participants) | Health Care Workers |
|---|---|
| United States | 41 |
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