Mask Fit Testing for Healthy Subjects

Recruiting at 1 trial location

Overseen By Patrice Ratliffe

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Pregnancy, Respiratory illness, Allergies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

500 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study is focused on mask fit testing and involves healthy participants, it is unlikely that you will need to change your medication routine.

What data supports the effectiveness of the treatment KN95 Mask Fit testing?

Research shows that FFP2 and other filtering facepiece respirators, similar to KN95 masks, provide better fit and filtration compared to surgical masks, which can enhance protection for healthcare workers against airborne particles. ^{1 2 3 4 5}

Is mask fit testing safe for humans?

Mask fit testing, including for KN95 and surgical masks, is generally safe for humans. It is commonly used to ensure proper protection for healthcare workers against airborne diseases. ^{1 2 6 7 8}

How does mask fit testing differ from other treatments for mask effectiveness?

Mask fit testing is unique because it evaluates how well different types of masks, like KN95 and surgical masks, fit an individual's face to ensure proper protection. This is different from other treatments that might focus on the material or filtration efficiency of the masks themselves, as fit testing specifically measures the mask's ability to seal and prevent particles from entering. ^{1 4 9 10 11}

What is the purpose of this trial?

This study examines the role of craniofacial dimensions and self-evaluation thereof in the protection afforded by masks commonly worn by the public as protection against aerosol contaminants. The effectiveness of instructions for self-evaluation of craniofacial dimensions will be tested against standard digital and manual craniometric methods. Approximately 500 (18+ year old) subjects. There will be two groups to complete this study (Group A and B). After consenting to participate in the study, subjects in Group A will use a short self-assessment questionnaire to measure their craniofacial dimensions, fill out a questionnaire, and have their face measured using standard anthropological techniques and a 3D camera. They will then enter a chamber containing an atmosphere of aerosolized salt particles where the fitted filtering efficiency of 2 types of face masks will be measured briefly. Subjects in Group B will only complete the craniometric assessment, self-assessment, and questionnaire. Participation time is approximately 60 minutes for Group A and 15 minutes for Group B.

Research Team

James Samet, PhD

Principal Investigator

U.S. Environmental Protection Agency

Eligibility Criteria

This trial is for healthy individuals aged 18-70, of any gender. Participants will be asked to self-assess their facial dimensions and undergo face measurements using anthropological techniques and a 3D camera.

Inclusion Criteria

I consider myself to be in good health.

I can walk and am okay with being in small, enclosed spaces.

Subjects must pass COVID-19 screening questions and have had at least a primary COVID-19 vaccination series

Exclusion Criteria

Individuals who have active allergies

Anyone who has been hospitalized overnight or sought urgent medical care in the last 30 days

I do not have any health conditions that could make this study risky for me.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Consent and Initial Assessment

Participants provide informed consent and complete initial assessments including a behavioral questionnaire and craniofacial measurements

1 day

1 visit (in-person)

Mask Fit Testing

Participants undergo mask fit testing using aerosolized sodium chloride particles to measure fitted filtration efficiency

1 day

1 visit (in-person)

Follow-up

Participants are monitored for any immediate adverse effects post mask fit testing

1 day

Treatment Details

Interventions

• KN95 Mask Fit testing
• Surgical/Procedure Mask Fit Testing

Trial Overview The study aims to determine how well common masks like KN95s and surgical masks fit based on the size and shape of a person's face. It involves comparing self-evaluation methods against standard measurement techniques in a controlled environment with aerosolized particles.

Participant Groups

Group I: Mask Testing Experimental Treatment 2 Interventions

All participants will be fit tested while completing a modified version of the OSHA fit test. The subject will remain seated in the chamber and complete a modified version the Occupational Safety and Health Administration Quantitative Fit Testing Protocol (Modified Ambient Aerosol CNC Quantitative Fit Testing Protocol for Filtering Facepiece TableA-2-RESPIRATORS). The subject will then move their head from left to right, taking two breaths at each extreme for 30 seconds. This will be followed by moving the head up and down, taking two beaths at each extreme for 30 seconds. The procedure will be repeated after the addition of a clip to the ear-loops of the mask behind the neck of the subject. In total, the testing time for the 2 masks with and without clip will be approximately 6 minutes.

Group II: Craniometric and Behavioral Assessment Active Control 1 Intervention

First, the subjects height and weight will be measured using standard methods (scale and stadiometer). They will be asked to remove their shoes and empty their pockets before being weighed. Four to eight face, head, and neck features will also be measured using spreading and sliding calipers and a measuring tape. Trained personnel (wearing gloves) will palpate the subjects face and to ensure proper caliper measurements are collected. Cosmetic pencils will be used to identify landmarks on the face and neck in order assist in the measurement of craniofacial features. Following facial measurements, a study team member will take a 3D picture of the subject's face using a camera. The image takes approximately 10 seconds to generate. We will first position the subject in from of the camera and ask them to tighten any loose hair so we can have a clear view of their ears. It is recommended that subjects wear a non-collared shirt, preferably a t-shirt. If they wea

KN95 Mask Fit testing is already approved in China, European Union, United States for the following indications:

Approved in China as KN95 Respirator for:

• Protection against airborne pathogens
• Prevention of respiratory infections

Approved in European Union as FFP2 Mask for:

• Protection against airborne pathogens
• Prevention of respiratory infections

Approved in United States as KN95 Respirator for:

• Emergency Use Authorization for protection against COVID-19

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

Environmental Protection Agency (EPA)

Collaborator

Trials

40

Recruited

95,500+

Findings from Research

In a study involving 180 fit-tests of nine types of FFP2 respirator masks across three hospitals, only 27% of the tests were successful, indicating that many masks did not fit properly for healthcare workers.

Flat-fold respirator masks had a significantly higher success rate (57.5%) compared to duckbill (18.3%) and hard shell masks (3.3%), suggesting that mask design plays a crucial role in ensuring effective respiratory protection for healthcare workers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of respirator masks for healthcare workers, in France. Ciotti, C., Pellissier, G., Rabaud, C., et al.[2019]

Combining a surgical mask with a highly efficient FFP respirator significantly enhances respiratory protection for healthcare workers, achieving a protection factor over 200, which is well above the minimum required level of 100.

The study utilized fit testing on healthcare workers in various breathing situations to quantify the effectiveness of different FFP respirators and their combinations with surgical masks, demonstrating that this combination improves fit and filtration efficiency against SARS-CoV-2 exposure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Analysis of the Adjustment of Self-Filtering Masks in Combination with Surgical Masks for the Protection of Health Professionals in the Care of Patients Affected by SARS-COV-2 from an Experimental Study]. García Vela, R., Cabanas Valdés, R., Huertas Ríos, S., et al.[2021]

In a study involving 20 healthcare workers, wearing either an FFP2 mask alone or in combination with a surgical mask did not significantly affect their oxygen saturation (SpO2) levels or pulse rates over a 60-minute period.

While there were some fluctuations in SpO2 values in the FFP2-surgical mask group, overall, both mask types were found to be safe and did not adversely impact vital signs during the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does combined usage of FFP2 and Surgical mask against SARS-CoV-2 affect SpO2 values and pulse rates of dental health-care workers? Bal, C., Aksoy, M., Ozturk, Z., et al.[2022]

In a study involving 78 physicians, FFP3 filtering respirators demonstrated a significantly higher fit factor compared to commonly used surgical masks, indicating better protection against airborne particles (P<0.001).

Despite the superior fit of FFP3 masks, 97% of participants still preferred using surgical masks in clinical settings, highlighting a gap between safety and practice in infection control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fit factor of masks used by Physicians in Clinical Settings. De-Yñigo-Mojado, B., Madera-García, J., Becerro-de-Bengoa-Vallejo, R., et al.[2021]

Two filtering facepiece respirators (FFR), one prototype and one commercial model, successfully met all eight proposed comfort and tolerance criteria identified by healthcare workers.

Three additional FFR, including two prototypes and one commercial model, passed seven out of eight criteria, indicating that while many designs show promise, further testing is needed to evaluate their overall effectiveness and user compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Project BREATHE - Prototype Respirator Evaluation Utilizing Newly Proposed Respirator Test Criteria. Kim, JH., Roberge, RJ., Shaffer, RE., et al.[2023]

In a study involving 100 participants, 13% failed fit testing when wearing a procedural mask over an N95 respirator, indicating that this combination may compromise the respirator's effectiveness.

The findings suggest that while N95 respirators are designed for high filtration efficiency, adding an overlying mask can negatively impact their fit and protective capabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two masks can be worse than one: N95 respirator failure caused by an overlying face mask. Mueller, JT., Geyer, HD., Karimi, S., et al.[2023]

FFP2/KN95 respirators show significant variability in their protective capabilities, highlighting the importance of proper fit testing for effective use.

Healthcare workers at risk for airborne diseases, such as COVID-19, influenza, or tuberculosis, should undergo fit testing to ensure optimal protection from these pathogens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Respirators evaluated by fit testing. Kleinjohann, L., Lange, C.[2020]

Several NIOSH-approved N95 filtering facepiece respirators (FFRs) demonstrated strong resistance to synthetic blood penetration, indicating their potential safety for use in healthcare settings during procedures involving body fluids.

The study suggests that incorporating FDA clearance requirements into the NIOSH approval process could increase the availability of effective surgical N95 FFRs, which is crucial during times of respirator shortages, such as a pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resistance to synthetic blood penetration of National Institute for Occupational Safety and Health-approved N95 filtering facepiece respirators and surgical N95 respirators. Rengasamy, S., Sbarra, D., Nwoko, J., et al.[2022]

Fluid Resistant Surgical Masks do not provide protection against inhaled smoke particles, indicating they may be inadequate for respiratory protection in healthcare settings.

FFP3 masks offer complete protection but require proper fit to avoid facial trauma, suggesting a need for improved fit testing and daily checks for healthcare workers using these masks, especially in areas with COVID-19 patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

COVID-19: smoke testing of surgical mask and respirators. Douglas, JDM., McLean, N., Horsley, C., et al.[2021]

A modified strapless surgical mask design significantly improved aerosol protection compared to standard loose-fitting surgical masks, achieving a median fit factor of 53.8, which indicates much lower inward leakage of aerosols (1.79%) compared to 29.5% for loose-fitting masks.

The sealed surgical mask provided better breathability and comfort than N95 FFRs, with participants rating it 9 out of 10 for both, suggesting it could be a viable alternative for healthcare workers during N95 shortages, although individual mask evaluations are still recommended.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Fit for Sealed and Loose-Fitting Surgical Masks and N95 Filtering Facepiece Respirators. Karuppasamy, K., Obuchowski, N.[2021]

The pilot trial focused on testing the fit of N95 respirator masks in a metropolitan general practice setting, highlighting the importance of proper mask fit for effective respiratory protection.

The study also examined how failures in mask fit testing were addressed, which is crucial for ensuring that healthcare workers are adequately protected against airborne pathogens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitative respirator fit tests for P2/N95 in Australian general practice. Chapman, D., Chapman, L., Ganesan, A.[2022]

References

1. France pubmed.ncbi.nlm.nih.gov

Effectiveness of respirator masks for healthcare workers, in France. [2019]

2. Spain pubmed.ncbi.nlm.nih.gov

[Analysis of the Adjustment of Self-Filtering Masks in Combination with Surgical Masks for the Protection of Health Professionals in the Care of Patients Affected by SARS-COV-2 from an Experimental Study]. [2021]

3. India pubmed.ncbi.nlm.nih.gov

Does combined usage of FFP2 and Surgical mask against SARS-CoV-2 affect SpO2 values and pulse rates of dental health-care workers? [2022]

4. Australia pubmed.ncbi.nlm.nih.gov

Fit factor of masks used by Physicians in Clinical Settings. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Project BREATHE - Prototype Respirator Evaluation Utilizing Newly Proposed Respirator Test Criteria. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Two masks can be worse than one: N95 respirator failure caused by an overlying face mask. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Respirators evaluated by fit testing. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Resistance to synthetic blood penetration of National Institute for Occupational Safety and Health-approved N95 filtering facepiece respirators and surgical N95 respirators. [2022]

9. England pubmed.ncbi.nlm.nih.gov

COVID-19: smoke testing of surgical mask and respirators. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Comparison of Fit for Sealed and Loose-Fitting Surgical Masks and N95 Filtering Facepiece Respirators. [2021]

11. Australia pubmed.ncbi.nlm.nih.gov

Quantitative respirator fit tests for P2/N95 in Australian general practice. [2022]