Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000065897
Ethics application status
Approved
Date submitted
27/10/2020
Date registered
27/01/2021
Date last updated
14/06/2024
Date data sharing statement initially provided
27/01/2021
Date results information initially provided
14/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
An investigation of fit test rates of N95 respirators after two to four hours usage in a real-world intensive care unit setting
Scientific title
An investigation of fit test rates of N95 respirators after two to four hours usage in a real-world intensive care unit setting
Secondary ID [1] 302632 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fit of N95 filtering mask 319542 0
Protection from airborne pathogens 319543 0
COVID-19 319544 0
Condition category
Condition code
Infection 317492 317492 0 0
Other infectious diseases
Respiratory 317526 317526 0 0
Other respiratory disorders / diseases
Public Health 317527 317527 0 0
Other public health

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Intervention code [1] 318935 0
Not applicable
Comparator / control treatment
Each participant serves as their own control, with the control being baseline fit test.
Control group
Active

Outcomes
Primary outcome [1] 325530 0
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)
Timepoint [1] 325530 0
Baseline and >2 hours use
Secondary outcome [1] 388437 0
Repeat fit test failure rates comparison between different respirator shapes (3 piece flat fold vs duckbill vs cup vs diamond)
Timepoint [1] 388437 0
Basline and at >2 hours
Secondary outcome [2] 436419 0
Time respirator worn, measured by time difference between time respirator donned to start time of repeat test
Timepoint [2] 436419 0
Between 2 and 4 hours

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2021
Actual
12/04/2021
Date of last participant enrolment
Anticipated
Actual
17/07/2022
Date of last data collection
Anticipated
Actual
17/07/2022
Sample size
Target
50
Accrual to date
Final
52
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 26680 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 42721 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 307063 0
Hospital
Name [1] 307063 0
Monash Health
Country [1] 307063 0
Australia
Primary sponsor type
Individual
Name
Samuel Reade
Address
Intensive Care Unit
Casey Hospital
62-70 Kangan Drive
Berwick
VIC
3806
Country
Australia
Secondary sponsor category [1] 307632 0
None
Name [1] 307632 0
Address [1] 307632 0
Country [1] 307632 0
Other collaborator category [1] 281522 0
Individual
Name [1] 281522 0
Umesh Kadam
Address [1] 281522 0
Intensive Care Unit
Casey Hospital
62-70 Kangan Drive
Berwick
VIC
3806
Country [1] 281522 0
Australia
Other collaborator category [2] 283089 0
Individual
Name [2] 283089 0
Dr Wisam Al-Bassam
Address [2] 283089 0
Country [2] 283089 0
Australia
Other collaborator category [3] 283090 0
Individual
Name [3] 283090 0
Dr Ahmad Bassam
Address [3] 283090 0
Country [3] 283090 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307187 0
Monash Health HREC
Ethics committee address [1] 307187 0
Research Support Services
Monash Health
Level 2, I Block
246 Clayton Road
Clayton Victoria 3168
Ethics committee country [1] 307187 0
Australia
Date submitted for ethics approval [1] 307187 0
14/09/2020
Approval date [1] 307187 0
Ethics approval number [1] 307187 0
Ethics committee name [2] 315516 0
Monash HREC
Ethics committee address [2] 315516 0
Level 2, I Block, Monash Medical Centre, 246 Clayton Road, Clayton, 3168. VIC
Ethics committee country [2] 315516 0
Australia
Date submitted for ethics approval [2] 315516 0
17/09/2020
Approval date [2] 315516 0
05/10/2020
Ethics approval number [2] 315516 0
RES-20-0000-717A

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 106330 0
Dr Samuel Reade
Address 106330 0
ICU dept.
Monash Medical Centre Clayton,
246 Clayton Road
Clayton
3168
VIC
Country 106330 0
Australia
Phone 106330 0
+61 3 9594 6666
Fax 106330 0
Email 106330 0
[email protected]
Contact person for public queries
Name 106331 0
Dr Samuel Reade
Address 106331 0
ICU dept.
Monash Medical Centre Clayton,
246 Clayton Road
Clayton
3168
VIC
Country 106331 0
Australia
Phone 106331 0
+61 3 9594 6666
Fax 106331 0
Email 106331 0
[email protected]
Contact person for scientific queries
Name 106332 0
Dr Samuel Reade
Address 106332 0
ICU dept.
Monash Medical Centre Clayton,
246 Clayton Road
Clayton
3168
VIC
Country 106332 0
Australia
Phone 106332 0
+61 3 9594 6666
Fax 106332 0
Email 106332 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.