Respiratory Protection Effect of Ear-loop-type KF94 Mask

Study Overview
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Brief Summary
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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 COVID-19 pandemic. However, no studies have assessed the adequacy of respiratory protection. In this prospective randomized open-label study, the investigators aimed to evaluate the fitting performance of ear-loop-type KF94 masks by the quantitative fit test according to the occupational safety and health administration (OSHA) protocol. In addition, by quantitatively comparing the tight-fitting method using a clip and the general-fitting method, the investigators tried to evaluate whether the tight-wearing method improves the fitting performance of KF94 masks.

Detailed Description
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Sample size: The sample size was calculated based on a pilot study of 10 participants, which examined the FF of general-fitting. The mean FF was 20.3, and the log-transformed FFs were assessed due to skewed data, which was 1.98 (standard deviation 1.34). We assumed that the FF for tight-fitting would increase by 50%, with an α value of .05, and a β error of .10 (power = 90%) for two-sided hypothesis testing. The estimated sample size calculation revealed a required sample of 24 participants. Therefore, 30 participants were enrolled to account for a 20% dropout rate. Data analyses: Repeated-measures analysis of variance or generalized estimating equations were used to compare the FFs or passing rate of the QNFTs for the three mask types according to the wearing method. Paired t-tests or Wilcoxon signed-rank tests were used to compare the FFs according to the wearing method for each mask type. McNemar's test was used to compare the passing rate of the QNFT according to the wearing method. Bonferroni's correction was performed for all results of each subgroup analysis. SAS ver. 9.4 software (SAS Institute, Cary, NC) was used to perform all statistical analyses.

Official Title
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Respiratory Protection Effect of Ear-loop-type KF94 Filtering Facepiece Respirators According to the Wearing Method: A Randomized, Open-label Study

Conditions
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Infection

Intervention / Treatment
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* Device: tight-fitting of KF94 mask with clip


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthcare workers with experience in wearing filtering facepiece respirator working in the hospital Exclusion Criteria: Individuals with expected difficulties in wearing masks or undergoing OSHA fit tests because of factors such as a facial anomaly, lung disease, or lower back disorder

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Participants were randomly assigned to groups A, B, and C to reduce learning effects according to the mask type | Device: tight-fitting of KF94 mask with clip<br>* The general-fitting method involved wearing a mask with ear loops, and the tight-fitting method involved wearing a clip that connected ear loops on the occiput after wearing a mask according to the general method<br>|
| Experimental: Group B<br>Participants were randomly assigned to groups A, B, and C to reduce learning effects according to the mask type | Device: tight-fitting of KF94 mask with clip<br>* The general-fitting method involved wearing a mask with ear loops, and the tight-fitting method involved wearing a clip that connected ear loops on the occiput after wearing a mask according to the general method<br>|
| Experimental: Group C<br>Participants were randomly assigned to groups A, B, and C to reduce learning effects according to the mask type | Device: tight-fitting of KF94 mask with clip<br>* The general-fitting method involved wearing a mask with ear loops, and the tight-fitting method involved wearing a clip that connected ear loops on the occiput after wearing a mask according to the general method<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total fit factors(FFs) of the quantitative fit tests (QNFT) according to the wearing method of the three types of KF94 masks |  | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| passing rate of the QNFT according to the wearing method |  | through study completion, an average of 1 year | 
| total FFs after user-seal-check and real-time adjustment |  | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Respiratory protective devices, quantitative fit test, N95 filtering facepiece respirators, infection control, KF94 mask