InfectionNCT04794556
Respiratory Protection Effect of Ear-loop-type KF94 Mask
A study testing tight-fitting of KF94 mask with clip in people with Infection, run by Samsung Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Infection
- What is being tested?
- tight-fitting of KF94 mask with clip
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2021to 10 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthcare workers with experience in wearing filtering facepiece respirator working in the hospital
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Respiratory Protection Effect of Ear-loop-type KF94 Filtering Facepiece Respirators According to the Wearing Method: A Randomized, Open-label Study
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.
Read the 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.
- Conditions
- Infection
- Being tested
- tight-fitting of KF94 mask with clip
- Keywords
- Respiratory protective devices, quantitative fit test, N95 filtering facepiece respirators, infection control, KF94 mask
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tight-fitting of KF94 mask with clipDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Participants were randomly assigned to groups A, B, and C to reduce learning effects according to the mask type Receives: 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 Receives: 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 Receives: Device: tight-fitting of KF94 mask with clip |
What is being measured
The primary outcome is the main question the study is designed to answer.
total fit factors(FFs) of the quantitative fit tests (QNFT) according to the wearing method of the three types of KF94 masks
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
passing rate of the QNFT according to the wearing method
Measured: through study completion, an average of 1 year
total FFs after user-seal-check and real-time adjustment
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start1 Jan 2021
- Primary completion10 Mar 2021
- Study completion10 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee Yoon, Samsung Medical Center
- Investigators
- Hee Yoon, MD., PhD., Study director, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04794556
- Sponsor's protocol ID
- KF94 mask
- Status last verified
- Mar 2021
- First submitted
- 8 Mar 2021
- Last updated
- 15 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34282608
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Protection Effect of Ear-loop-type KF94 Filtering Facepiece Respirators According to the Wearing Method: A Randomized, Open-label Study
- ClinicalTrials.gov ID
- NCT04794556
- Acronym / sponsor ID
- KF94 mask
- Conditions
- Infection
- Keywords
- Respiratory protective devices, quantitative fit test, N95 filtering facepiece respirators, infection control, KF94 mask
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 10 Mar 2021 (actual)
- Study completion
- 10 Mar 2021 (actual)
- First posted
- 12 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: tight-fitting of KF94 mask with clipParticipants were randomly assigned to groups A, B, and C to reduce learning effects according to the mask type |
| Group B | Experimental | Device: tight-fitting of KF94 mask with clipParticipants were randomly assigned to groups A, B, and C to reduce learning effects according to the mask type |
| Group C | Experimental | Device: tight-fitting of KF94 mask with clipParticipants were randomly assigned to groups A, B, and C to reduce learning effects according to the mask type |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthcare workers with experience in wearing filtering facepiece respirator working in the hospital
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tight-fitting of KF94 mask with clipThe 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 | Device | Group A, Group B, Group C |
Primary outcome
total fit factors(FFs) of the quantitative fit tests (QNFT) according to the wearing method of the three types of KF94 masks
Time frame: through study completion, an average of 1 year
2 secondary outcomes
passing rate of the QNFT according to the wearing method
Time frame: through study completion, an average of 1 year
total FFs after user-seal-check and real-time adjustment
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2021.
- Derived from this study: PubMed 34282608Yang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hee Yoon, MD., PhD. study director
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tight-fitting of KF94 mask with clip in people with Infection, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total fit factors(FFs) of the quantitative fit tests (QNFT) according to the wearing method of the three types of KF94 masks (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04794556, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2021.