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NCT04794556Completed

Respiratory Protection Effect of Ear-loop-type KF94 Mask

Respiratory Protection Effect of Ear-loop-type KF94 Filtering Facepiece Respirators According to the Wearing Method: A Randomized, Open-label Study
Samsung Medical CenterClinicalTrials.govdeviceDevice trial
Verified
Study focus
Disease/Condition
Infection
Drug/Device/Intervention
tight-fitting of KF94 mask with clip
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
Samsung Medical Center
Location
Seoul, South Korea
Timeline & enrollment
Phase
N/A
Start date
Jan 01, 2021
End date
Mar 10, 2021
Enrollment
30 participants
Primary outcome

total fit factors(FFs) of the quantitative fit tests (QNFT) according to the wearing method of the three types of KF94 masks

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.

ICD-10 classifications
Bacterial infection, unspecifiedBacterial, viral and other infectious agentsInfection following immunizationOther infectious diseasesViral infection, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT04794556
Type
Device Trial
About this record

Access comprehensive clinical trial information for NCT04794556 through Pure Global AI's free database. This phase not specified trial is sponsored by Samsung Medical Center and is currently Completed. The study focuses on Infection. Target enrollment is 30 participants.

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