Respiratory Protection Effect of Ear-loop-type KF94 Mask

Not Applicable

Completed

• Conditions: Infection
• Interventions: Device: tight-fitting of KF94 mask with clip

• Registration Number: NCT04794556
• Lead Sponsor: Samsung Medical Center

Brief Summary

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

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.

Study Timeline

• Study Start: 2021-01-01
• Status Verified: 2021-03
• Study First Submitted: 2021-03-08
• Primary Completion: 2021-03-10
• Study Completion: 2021-03-10
• Study First Submitted QC: 2021-03-10
• Study First Posted: 2021-03-12
• Last Update Submitted: 2021-03-12
• Last Update Posted: 2021-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	tight-fitting of KF94 mask with clip	Participants were randomly assigned to groups A, B, and C to reduce learning effects according to the mask type
Group A	tight-fitting of KF94 mask with clip	Participants were randomly assigned to groups A, B, and C to reduce learning effects according to the mask type
Group C	tight-fitting of KF94 mask with clip	Participants were randomly assigned to groups A, B, and C to reduce learning effects according to the mask type

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of