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

Not Applicable

Completed

• Conditions: Fit of N95 filtering mask; Protection from airborne pathogens; COVID-19; Infection - Other infectious diseases; Respiratory - Other respiratory disorders / diseases; Public Health - Other public health

• Registration Number: ACTRN12621000065897
• Lead Sponsor: Samuel Reade

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-27
• Study Completion: 2022-07-17
• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 52

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fit testing rates after at least TWO hours of real-world use in an intensive care unit after successful fit test at baseline. Passing of fit testing is defined as per the manufacturers fit testing protocol, ie participants are unable to taste the saccharin agent when wearing the hood through the N95 in all 7 manoeuvres (Normal breathing, deep breathing, moving head side to side, moving head up and down, bending over, talking, normal breathing again (1 minute each)[ Baseline and >2 hours use]

Secondary Outcome Measures

Name	Time	Method
Repeat fit test failure rates comparison between different respirator shapes (3 piece flat fold vs duckbill vs cup vs diamond)[ Basline and at >2 hours];Time respirator worn, measured by time difference between time respirator donned to start time of repeat test[ Between 2 and 4 hours]