Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000388819
Ethics application status
Approved
Date submitted
25/03/2021
Date registered
8/04/2021
Date last updated
30/03/2022
Date data sharing statement initially provided
8/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of different N95 styles on fit testing in an Australian healthcare setting during the COVID-19 pandemic
Scientific title
Head to head comparison of different N95 styles on quantitative fit testing in Australian healthcare workers during the COVID-19 pandemic
Secondary ID [1] 303797 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infection control 321305 0
COVID-19 transmission 321306 0
Condition category
Condition code
Infection 319091 319091 0 0
Other infectious diseases
Respiratory 319210 319210 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Each healthcare worker will be sequentially tested on 4 N95 respirators in random order. The respirators included are: BSN Medical ProShield (duckbill style), 3M Aura (three panel style), 3M 1860 (cup style), BYD N95 (fold style). Testing will be conducted with a PortaCount machine using the modified OSHA protocol. No washout period is required between testing different respirators.
The participant will then assess the ease of donning and doffing at the conclusion of fit testing. The participant will be instructed to wear each respirator for 30 minutes and then assess the comfort of the respirator. The questionnaires will be in the form of a numerical rating scale.
Prior to commencing fit testing, data on age, gender, BMI, ethnicity and facial anthropometry (Menton-Sellion length and bizygomatic breadth) will be collected.
Intervention code [1] 320102 0
Not applicable
Comparator / control treatment
The N95 respirators will be compared to each other.
Control group
Active

Outcomes
Primary outcome [1] 327081 0
The primary outcome is the pass rate of the different brand/styles of N95 respirator.
A respirator is considered a pass if the fit factor is > or = 100 on testing with the modified OSHA protocol using a PortaCount machine. If the fit factor is < 100, then the participant is allowed to modify the respirator placement using the real time mode on the portacount machine and allowed a second test. If the second fit test achieves a fit factor of > or = 100, this is recorded as a pass. If the fit factor remains <100, this is recorded as a fail.
Each respirator will be tested using this method.
Timepoint [1] 327081 0
The primary endpoint is at the conclusion of each respirator fit test.
Secondary outcome [1] 393344 0
Ease of donning
Timepoint [1] 393344 0
At the conclusion of fit testing of each N95 respirator, using a numerical rating scale.
Secondary outcome [2] 393701 0
Ease of doffing
Timepoint [2] 393701 0
At the conclusion of fit testing of each N95 respirator, using a numerical rating scale.
Secondary outcome [3] 393702 0
Comfort
Timepoint [3] 393702 0
After wearing each N95 respirator for at least 30 minutes, the participant is asked to assess the comfort of the respirator using a numerical rating scale.

Eligibility
Key inclusion criteria
Healthcare workers who may be required to wear N95 respirator at work
Gives informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Healthcare workers who would not usually wear a N95 respirator
Does not consent

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
The primary analysis will use Cochran’s Q Test (a=0.05) to investigate the global null hypothesis that all four types of mask have the same pass rate. Pairwise comparisons of the masks will use McNemar’s Test. A stringent Bonferroni adjustment will be made to the significance level for each test.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2021
Actual
2/07/2021
Date of last participant enrolment
Anticipated
Actual
7/09/2021
Date of last data collection
Anticipated
Actual
7/10/2021
Sample size
Target
150
Accrual to date
Final
145
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 19023 0
Box Hill Hospital - Box Hill
Recruitment postcode(s) [1] 33568 0
3128 - Box Hill

Funding & Sponsors
Funding source category [1] 308186 0
Self funded/Unfunded
Name [1] 308186 0
Country [1] 308186 0
Primary sponsor type
Hospital
Name
Department of Anaesthesia, Box Hill Hospital, Eastern Health
Address
Department of Anaesthesia, Box Hill Hospital
5 Arnold Street, Box Hill 3168
Country
Australia
Secondary sponsor category [1] 309069 0
None
Name [1] 309069 0
None
Address [1] 309069 0
N/A
Country [1] 309069 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308169 0
Eastern Health Human Research Ethics Comittee
Ethics committee address [1] 308169 0
Ethics committee country [1] 308169 0
Australia
Date submitted for ethics approval [1] 308169 0
25/09/2020
Approval date [1] 308169 0
27/04/2021
Ethics approval number [1] 308169 0
LR20-095-68257

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109782 0
Dr Caitlin Low
Address 109782 0
Department of Anaesthesia
Box Hill Hospital
5 Arnold Street
Box Hill 3168
Victoria
Country 109782 0
Australia
Phone 109782 0
+61398953164
Fax 109782 0
Email 109782 0
[email protected]
Contact person for public queries
Name 109783 0
Caitlin Low
Address 109783 0
Department of Anaesthesia
Box Hill Hospital
5 Arnold Street
Box Hill 3168
Victoria
Country 109783 0
Australia
Phone 109783 0
+61398953164
Fax 109783 0
Email 109783 0
[email protected]
Contact person for scientific queries
Name 109784 0
Caitlin Low
Address 109784 0
Department of Anaesthesia
Box Hill Hospital
5 Arnold Street
Box Hill 3168
Victoria
Country 109784 0
Australia
Phone 109784 0
+61398953164
Fax 109784 0
Email 109784 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Pass/fail of each respirator fit test, after de-identification
When will data be available (start and end dates)?
Following publication of data, no end date determined.
Available to whom?
Researcher who are affiliated to a research institution who provide a methodologically sound proposal. Assessed on a case by case basis.
Available for what types of analyses?
For meta-analyses, systematic reviews.
How or where can data be obtained?
Data can be obtained by contacting the principal investigator via email at [email protected] or via the Department of Anaesthesia, Box Hill Hospital, 5 Arnold Street, Box Hill 3168. Ph: +613 9895 3164


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
SourceTitleYear of PublicationDOI
EmbasePass rates of four P2/N95 respirators or filtering facepiece respirators in Australian healthcare providers: A prospective observational study.2023https://dx.doi.org/10.1177/0310057X231154017
N.B. These documents automatically identified may not have been verified by the study sponsor.