Skip to content

An investigation of fit test rates of N95 respirators after two to four hours usage in a real-world intensive care unit setting

An investigation of fit test rates of N95 respirators after two to four hours usage in a real-world intensive care unit setting

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12621000065897
Enrollment
52
Registered
2021-01-27
Start date
2021-04-12
Completion date
2022-07-17
Last updated
2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Current guidelines in Victoria do not recommend fit testing of N95 respirators (tight fitting face masks). In addition they recommend use of N95 respirators for 4 hours before changing. Therefore we sought to test this as our hypothesis. The purpose of the study was to test the N95 fit test rates after 4 hours of use in a real-world intensive care unit setting to help assess if they adequately protected healthcare workers.

Interventions

Healthcare workers in a metropolitan intensive care unit will be invited to undergo fit testing of N95 respirators. They will be tested at baseline and at least two hours later in a real world ICU setting, to assess fit testing rates after 2-4 hours of use. Participants will not be tested if they have exposure to confirmed or suspected COVID-19 patients on that day as this may put the participant or tester at risk of COVID-19. Fit testing will be performed using the FT-10 3M Qualitative Fit Te

Healthcare workers in a metropolitan intensive care unit will be invited to undergo fit testing of N95 respirators. They will be tested at baseline and at least two hours later in a real world ICU setting, to assess fit testing rates after 2-4 hours of use. Participants will not be tested if they have exposure to confirmed or suspected COVID-19 patients on that day as this may put the participant or tester at risk of COVID-19. Fit testing will be performed using the FT-10 3M Qualitative Fit Test Apparatus Kit - Sweet (Saccharin) respirator test qualitative test. This is a validated testing protocol as per the standard AS/NZS 1715. The testing protocol is well validated and is described in detail in both the manufacturer’s instructions and elsewhere. Fit testing will be undertaken by the researchers, and 3M have agreed to provide training on carrying out fit testing procedures. The range of respirators available for fit testing is: Proshield N95 size medium Proshield N95 size small Halyard Fluid Shield 3 (Small/Medium) 3M 1860s mask size small BYD CARE Foldable N95 Particulate Respirator (“one-size fits all”) BYD DE2322. 3M Aura 1870+ Trident P2 respirator. These are the currently available brands in the study ICUs. If local supply changes or new respirator designs become available these may also be bested. Participants who fail on one mask at baseline may immediately try fit testing with a different brand. Fit testing is expected to take around 30 minutes per participant. Due to the introduction of formal fit testing in our institution, participants were required to only enter the study using a respirator with which they had passed formal fit testing.

Sponsors

Samuel Reade
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1) All healthcare workers in patient facing role working with the study ICUs. 2) Where HCWs had failed the baseline fit test they were permitted to re-enter the study using a different design of N95.

Exclusion criteria

1) Participants who were unable to complete both baseline and repeat testing without leaving the ICU 2) Any participants who caring for Covid-19 suspected or confirmed patients on that day, due to the risk of spreading infection/self-contamination 3) Any male participants with facial hair in the respirator contact area, due to high chance of failure 4) Any participants with current respiratory symptoms 5) Any participants with allergy to saccharin or claustrophobia.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026