Respiratory Protection Effect of Ear-loop-type KF94 Mask
12 mars 2021 uppdaterad av: Hee Yoon, Samsung Medical Center
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
30
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
-
Seoul, Korea, Republiken av, 06351
- Samsung Medical Center
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 65 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Group A
Participants were randomly assigned to groups A, B, and C to reduce learning effects according to the mask type
|
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
|
|
Experimentell: Group B
Participants were randomly assigned to groups A, B, and C to reduce learning effects according to the mask type
|
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
|
|
Experimentell: Group C
Participants were randomly assigned to groups A, B, and C to reduce learning effects according to the mask type
|
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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
total fit factors(FFs) of the quantitative fit tests (QNFT) according to the wearing method of the three types of KF94 masks
Tidsram: through study completion, an average of 1 year
|
through study completion, an average of 1 year
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
passing rate of the QNFT according to the wearing method
Tidsram: through study completion, an average of 1 year
|
through study completion, an average of 1 year
|
|
total FFs after user-seal-check and real-time adjustment
Tidsram: through study completion, an average of 1 year
|
through study completion, an average of 1 year
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Hee Yoon, MD., PhD., Samsung Medical Center
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 januari 2021
Primärt slutförande (Faktisk)
10 mars 2021
Avslutad studie (Faktisk)
10 mars 2021
Studieregistreringsdatum
Först inskickad
8 mars 2021
Först inskickad som uppfyllde QC-kriterierna
10 mars 2021
Första postat (Faktisk)
12 mars 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
15 mars 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
12 mars 2021
Senast verifierad
1 mars 2021
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- KF94 mask
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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