Respiratory Protection Effect of Ear-loop-type KF94 Mask

NCT04794556 | Completed

• 1 other identifier: KF94 mask
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Infection

Keywords

Respiratory protective devices; quantitative fit test; N95 filtering facepiece respirators; infection control; KF94 mask

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (3)

Group A

EXPERIMENTAL

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

Group B

EXPERIMENTAL

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

Group C

EXPERIMENTAL

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

Interventions

tight-fitting of KF94 mask with clip DEVICE

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

Group A; Group B; Group C

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthcare workers with experience in wearing filtering facepiece respirator working in the hospital

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

Location

Related Publications (1)

• Yang HJ, Yoon H, Kang SY, Lee G, Park JE, Kim T, Lee SU, Hwang SY, Cha WC, Shin TG, Jo IJ. Respiratory Protection Effect of Ear-loop-type KF94 Masks according to the Wearing Method in COVID-19 Pandemic: a Randomized, Open-label Study. J Korean Med Sci. 2021 Jul 19;36(28):e209. doi: 10.3346/jkms.2021.36.e209.

  PMID: 34282608 DERIVED

MeSH Terms

Conditions

Infections

Interventions

Surgical Instruments

Intervention Hierarchy (Ancestors)

Surgical Equipment; Equipment and Supplies

Study Officials

• Hee Yoon, MD., PhD.

  Samsung Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: March 12, 2021
• Study Start: January 1, 2021
• Primary Completion: March 10, 2021
• Study Completion: March 10, 2021
• Last Updated: March 15, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)