Trial Outcomes & Findings for New Reusable Mask Design With Superior Filtration and Fit (NCT NCT04826809)
NCT ID: NCT04826809
Last Updated: 2023-07-07
Results Overview
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)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
41 participants
Primary outcome timeframe
Baseline
Results posted on
2023-07-07
Participant Flow
Participant milestones
| Measure |
Health Care Workers
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
N95 mask: Standard 1870 N95 one time use mask
Nordell single E-100 layer mask: Nordell mask design using one layer of E-100 fabric plus cotton fabric overlay
Nordell double E-100 layer mask: Nordell mask design using two layers of E-100 fabric
|
|---|---|
|
Overall Study
STARTED
|
41
|
|
Overall Study
COMPLETED
|
41
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
New Reusable Mask Design With Superior Filtration and Fit
Baseline characteristics by cohort
| Measure |
Health Care Workers
n=41 Participants
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
N95 mask: Standard 1870 N95 one time use mask
Nordell single E-100 layer mask: Nordell mask design using one layer of E-100 fabric plus cotton fabric overlay
Nordell double E-100 layer mask: Nordell mask design using two layers of E-100 fabric
|
|---|---|
|
Age, Customized
Between 18 and 29 years
|
3 Participants
n=5 Participants
|
|
Age, Customized
Between 30 and 39 years
|
15 Participants
n=5 Participants
|
|
Age, Customized
Between 40 and 49 years
|
11 Participants
n=5 Participants
|
|
Age, Customized
Between 50 and 59 years
|
8 Participants
n=5 Participants
|
|
Age, Customized
>= 60 years
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White, non-Hispanic
|
37 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian/Pacific Islander
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: One participant was excluded from analysis of this outcome measure due to recent viral illness
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.
Outcome measures
| Measure |
Health Care Workers
n=40 Participants
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 N95 mask: Standard 1870 N95 one time use mask Nordell single E-100 layer mask: Nordell mask design using one layer of E-100 fabric plus cotton fabric overlay Nordell double E-100 layer mask: Nordell mask design using two layers of E-100 fabric
|
|---|---|
|
Comparison of Fit Tests
Fit Test N95
|
39 Participants
|
|
Comparison of Fit Tests
Fit Test Nordell Single Layer Mask
|
39 Participants
|
|
Comparison of Fit Tests
Fit Test Nordell Double Layer Mask
|
40 Participants
|
PRIMARY outcome
Timeframe: BaselineMeasured 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)
Outcome measures
| Measure |
Health Care Workers
n=41 Participants
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 N95 mask: Standard 1870 N95 one time use mask Nordell single E-100 layer mask: Nordell mask design using one layer of E-100 fabric plus cotton fabric overlay Nordell double E-100 layer mask: Nordell mask design using two layers of E-100 fabric
|
|---|---|
|
Comfort Level of Nordell Double E-100 Layer Mask
0 = most uncomfortable
|
0 Participants
|
|
Comfort Level of Nordell Double E-100 Layer Mask
1
|
1 Participants
|
|
Comfort Level of Nordell Double E-100 Layer Mask
2
|
0 Participants
|
|
Comfort Level of Nordell Double E-100 Layer Mask
3
|
4 Participants
|
|
Comfort Level of Nordell Double E-100 Layer Mask
4
|
22 Participants
|
|
Comfort Level of Nordell Double E-100 Layer Mask
5 = most comfortable
|
14 Participants
|
PRIMARY outcome
Timeframe: BaselineMeasured 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)
Outcome measures
| Measure |
Health Care Workers
n=41 Participants
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 N95 mask: Standard 1870 N95 one time use mask Nordell single E-100 layer mask: Nordell mask design using one layer of E-100 fabric plus cotton fabric overlay Nordell double E-100 layer mask: Nordell mask design using two layers of E-100 fabric
|
|---|---|
|
Ability to Breathe With Nordell Double E-100 Layer Mask
0 (worst)
|
0 Participants
|
|
Ability to Breathe With Nordell Double E-100 Layer Mask
1
|
0 Participants
|
|
Ability to Breathe With Nordell Double E-100 Layer Mask
2
|
1 Participants
|
|
Ability to Breathe With Nordell Double E-100 Layer Mask
3
|
4 Participants
|
|
Ability to Breathe With Nordell Double E-100 Layer Mask
4
|
11 Participants
|
|
Ability to Breathe With Nordell Double E-100 Layer Mask
5 (best)
|
25 Participants
|
Adverse Events
Health Care Workers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place