Assessment of Cloth Face Coverings as Source Control Under Laboratory and Simulated Field Conditions

NCT05216939 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2022-05-17

No results posted yet for this study

Summary

Cloth masks have been evaluated as a potential substitute for personal protective equipment (PPE) and found lacking. Prior to the COVID-19 outbreak, the use of cloth masks was limited and the focus of the limited research available was on the filtration of various fabrics in comparison to either surgical masks or N95 respirators. The Centers for Disease Control and Prevention (CDC) guidance for the coronavirus (COVID-19) outbreak makes it clear that cloth masks are not to be considered as PPE for healthcare workers and should be used in the healthcare setting only as a last resort when no other masks or respirators are available. While cloth masks are not recommended to be used as PPE, the use of cloth masks as primary source control has not yet been examined.

Conditions

  • Masks

Interventions

OTHER

Flannel mask with ear loops

Participants will have a mask fit test and will wear a flannel mask with ear loops. While wearing the flannel mask, participants will perform a sequence of activities. The researchers will note whether the mask lost its fit (e.g., slipping off the nose or face). Between activities, participants will be told to re-adjust the mask. Participants will be assigned to a specific speed on a treadmill with no incline, either 1.5 mph, the 'light' activity level, or 3 mph, the 'moderate' activity level. They will walk on the treadmill for 10 minutes. Prior to the treadmill activity, participants will rate the comfort and fit of the mask. Near the end of the activity, participants will rate their perceived exertion and again rate the comfort of the mask. Participants will complete a post-experiment questionnaire following all activities.

OTHER

Flannel mask with ties

Participants will have a mask fit test and will wear a flannel mask with ties. While wearing the flannel mask, participants will perform a sequence of activities. The researchers will note whether the mask lost its fit (e.g., slipping off the nose or face). Between activities, participants will be told to re-adjust the mask. Participants will be assigned to a specific speed on a treadmill with no incline, either 1.5 mph, the 'light' activity level, or 3 mph, the 'moderate' activity level. They will walk on the treadmill for 10 minutes. Prior to the treadmill activity, participants will rate the comfort of the mask. Near the end of the activity, participants will rate their perceived exertion and again rate the comfort of the mask. Participants will complete a post-experiment questionnaire following all activities.

OTHER

Twill mask with ear loops

Participants will have a mask fit test and will wear a twill mask with ear loops. While wearing the twill mask with ear loops, participants will perform a sequence of activities. The researchers will note whether the mask lost its fit (e.g., slipping off the nose or face). Between activities, participants will be told to re-adjust the mask. Participants will be assigned to a specific speed on a treadmill with no incline, either 1.5 mph, the 'light' activity level, or 3 mph, the 'moderate' activity level. They will walk on the treadmill for 10 minutes. Prior to the treadmill activity, participants will rate the comfort of the mask. Near the end of the activity, participants will rate their perceived exertion and again rate the comfort of the mask. Participants will complete a post-experiment questionnaire following all activities.

OTHER

Twill mask with ties

Participants will have a mask fit test and will wear a twill mask with ties. While wearing the twill mask with ties, participants will perform a sequence of activities. The researchers will note whether the mask lost its fit (e.g., slipping off the nose or face). Between activities, participants will be told to re-adjust the mask. Participants will be assigned to a specific speed on a treadmill with no incline, either 1.5 mph, the 'light' activity level, or 3 mph, the 'moderate' activity level. They will walk on the treadmill for 10 minutes. Prior to the treadmill activity, participants will rate the comfort of the mask. Near the end of the activity, participants will rate their perceived exertion and again rate the comfort of the mask. Participants will complete a post-experiment questionnaire following all activities.

Sponsors & Collaborators

Principal Investigators

  • Colleen Kraft, MD, MSc · Emory University

  • Andrea L Shane, MD MPH MSc · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-08
Primary Completion
2022-02-22
Completion
2022-02-22

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05216939 on ClinicalTrials.gov