New Reusable Mask Design With Superior Filtration and Fit

NCT04826809 | Completed Results FDA Device

• 1 other identifier: 20-011897
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Tuberculosis; Respiratory Viral Infection

Keywords

PPE; mask; N95; pandemic; mask shortage

Outcome Measures

Primary Outcomes (3)

• 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.

  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)

  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)

  Baseline

Study Arms (1)

Health care workers

EXPERIMENTAL

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

Interventions

N95 mask DEVICE

Standard 1870 N95 one time use mask

Health care workers

Nordell single E-100 layer mask DEVICE

Nordell mask design using one layer of E-100 fabric plus cotton fabric overlay

Health care workers

Nordell double E-100 layer mask DEVICE

Nordell mask design using two layers of E-100 fabric

Health care workers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- History of uncontrolled asthma, pneumonia, or hypertension.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Health System in Mankato

Mankato, Minnesota, 56001, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

COVID-19; Tuberculosis

Interventions

N95 Respirators

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Surgical Attire; Equipment and Supplies, Hospital; Equipment and Supplies; Respiratory Protective Devices; Personal Protective Equipment; Protective Devices; Surgical Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Dr. Janielle R. Nordell
• Organization: Mayo Clinic

Nordell.Janielle@mayo.edu

507-594-4700

Study Officials

• Janielle R Nordell, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: April 1, 2021
• Study Start: April 9, 2021
• Primary Completion: October 27, 2022
• Study Completion: October 27, 2022
• Last Updated: July 7, 2023
• Results First Posted: July 7, 2023

Record last verified: 2023-06

Locations

US (1)