Dataset Information

Respiratory Protection Effect of Ear-loop-type KF94 Masks according to the Wearing Method in COVID-19 Pandemic: a Randomized, Open-label Study.

ABSTRACT:

Background

Ear-loop-type Korean Filter 94 masks (KF94 masks, equivalent to the N95 and FFP2) are broadly used in health care settings in Korea for the coronavirus disease 2019 pandemic.

Methods

A prospective randomized open-label study was designed to identify differences in the fitting performance between mask wearing methods in three different types of KF94 mask with ear loops between January to March 2021. General-fitting involved wearing an ear-loop-type KF94 mask, and tight-fitting involved wearing a mask aided by a clip connecting the ear loops. Each of the 30 participants wore three types of masks according to a randomly assigned order in both methods and performed a total of six quantitative fit tests (QNFTs) according to the occupational safety and health administration protocol.

Results

All fit factors (FFs) measured by the QNFT were significantly higher for tight-fitting method with the clip in all KF94 masks (P < 0.001). However, the total FFs were very low, with a median (interquartile range) of 6 (3-23) and 29 (9-116) for general-fitting and tight-fitting, respectively. When wearing tightly, the horizontal 3-fold type mask with adjustable ear-loop length had the highest FF, with a median of 125, and the QNFT pass rate (FF ≥ 100) increased significantly from 4 (13%) to 18 (60%).

Conclusion

Even with sufficient filter efficiency, ear-loop-type-KF94 masks do not provide adequate protection. However, in relatively low-risk environments, wearing a face-seal adjustable KF94 mask and tight wearing with a clip can improve respiratory protection for healthcare workers.

Trial registration

ClinicalTrials.gov Identifier: NCT04794556.

SUBMITTER: Yang HJ

PROVIDER: S-EPMC8289716 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundRespiratory infections are common in the pediatric population. Preschoolers, especially those in kindergarten and 3-6 years old, are highly vulnerable to various respiratory infections.ObjectiveTo investigate the efficacy of indoor mask-wearing in mitigating respiratory infections in preschoolers in a real-world campus setting.MethodsThe study was conducted over a 115-day period in a kindergarten. Eligible children were assigned into study and control groups. The study group wore masks indoors but not outdoors, and the control group did not wear masks in either setting. We used a questionnaire to collect participant information, including age, height, weight, monthly dietary living expenses, family annual income, parent education level, primary caregiver, number of family members, and number of children under 6 years of age in the household. Incidences of clinical respiratory infections were recorded. We calculated the relative risk and analyzed the relationship between mask-wearing and respiratory infections by inter-group comparison, logistic regression, and Cox regression analyses.ResultsA total of 135 preschoolers were included, with 35 and 100 preschoolers in the study and control groups, respectively. Baseline comparisons showed a significant difference in the number of children under 6 years old in the household between the two groups. Mask-wearing did not significantly reduce the risk of respiratory infections (RR = 1.086, 95% CI: 0.713, 1.435). Logistic and Cox regression analyses also showed no significant relationship between mask-wearing and occurrence of respiratory infections after controlling for potential confounders (OR = 0.816, 95% CI: 0.364, 1.826, and HR = 0.845, 95% CI: 0.495, 1.444).ConclusionIndoor mask-wearing did not reduce the incidence of respiratory infections in preschoolers in a real-world campus setting. However, this study included a small number of preschoolers and observed them for a short period of time. Preschoolers were instructed to wear masks only when indoors. These factors could lead to bias and limit the generalizability of the study results.