NCT05388201

Variation In Facial Morphology As A Determinant Of Face Covering Performance: FACEFIT

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study examines the role of variations in the dimensions of facial features on the fitted filtering efficiency of face coverings available to the public during the COVID-19 pandemic. Approximately 100 young (18-55 years old) healthy participants will be recruited. Exclusionary criteria include pregnancy and breastfeeding. After informed consent, participants will enter a chamber where they will undergo 3D facial scanning using a dedicated camera system and be trained to don an N95 respirator properly. The fitted filtering efficiency (FFE) of 4 types of face coverings: a N95 respirator, a KN95 respirator (with and without a clip), a surgical mask (with and without a clip), and a KF94 respirator (with and without a clip) will be tested on each participant using the OSHA quantitative fit testing protocol for filtering face pieces.

Detailed description

Consenting: The investigators will review the inclusion and exclusion criteria and any medical conditions that the participant may have or medications that they are currently taking. The investigators will go over the study protocol in detail so that the participant will know what to expect during the study procedure. Lung Function Test: The participant will perform a breathing test (peak flow meter) before and after the facemask testing. This test measures the volume of air that the participant can blow out (exhale) quickly after taking a very deep breath. This is a method for measuring lung function and it must meet certain criteria prior to testing. 3D Facial Measurement and Imaging: The participants 3D facial features will be measured by facial calipers. Trained personnel (wearing gloves) will need to touch areas of the participants face and scalp to ensure proper caliper measurements are collected. A 3D picture of the participants face will be taken using a special 3D camera. Video Instruction on Wearing an N-95 Respirator: The participant will watch a short video showing proper ways to wear an N-95 respirator. Assessment of the Performance of Face Coverings: The participant will enter a study chamber where tiny sodium chloride (table salt) particles are emitted by a particle generator. The participant will be fit tested wearing different types of face coverings that include an N95-rated respirator, a KN95 mask (with and without clip), a surgical mask (with and without clip), and a KF94 respirator (with and without clip). During the test, the participant will be asked to perform a few tasks such as bending over, talking, etc. 3D images of the participants head, while wearing the masks, will be taken following each test.

Conditions

• Healthy

Interventions

Type	Name	Description
OTHER	N95	3M N95 Respirator
OTHER	KN95	KN95 Mask (with and without clip)
OTHER	KF94	KF94 Mask (with and without clip)
OTHER	Surgical	Surgical Mask (with and without clip)

Timeline

• Start date: 2022-06-01
• Primary completion: 2023-08-30
• Completion: 2023-08-30
• First posted: 2022-05-24
• Last updated: 2024-02-29

Locations

1 site across 1 country: United States