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Respiratory Protection Effect of Ear-loop-type KF94 Mask - Trial NCT04794556

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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NCT04794556
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Trial Details
ClinicalTrials.gov โ€ข NCT04794556
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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

Study Focus

Infection

tight-fitting of KF94 mask with clip

Interventional

device

Sponsor & Location

Samsung Medical Center

Seoul, South Korea

Timeline & Enrollment

N/A

Jan 01, 2021

Mar 10, 2021

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, unspecified
Bacterial, viral and other infectious agents
Infection following immunization
Other infectious diseases
Viral infection, unspecified

Data Source

ClinicalTrials.gov

NCT04794556

Device Trial