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Trial registered on ANZCTR


Registration number
ACTRN12620000688987
Ethics application status
Approved
Date submitted
21/05/2020
Date registered
19/06/2020
Date last updated
19/06/2020
Date data sharing statement initially provided
19/06/2020
Date results information initially provided
19/06/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparing the user seal check and fit test between two types of N95 respirators - the Halyard N95 Particulate Filter Respirators and the ProShield® N-95 masks
Scientific title
Comparing the user seal check and fit test between two types of N95 respirators in anaesthetic staff members - the Halyard N95 Particulate Filter Respirators and the ProShield® N-95 masks
Secondary ID [1] 301332 0
Nil Known
Universal Trial Number (UTN)
U1111-1252-2924
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Airborne transmitted disease 317535 0
COVID-19 317695 0
Condition category
Condition code
Infection 315626 315626 0 0
Other infectious diseases
Respiratory 315773 315773 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We will perform a user seal check and a quantitative fit testing of N95 masks on a total of 80 of the anaesthetic staff members. Before the commencement of the study, all participants will have received a formal personal protective equipment (PPE) training session, which includes N95 masks donning/doffing technique and user seal check method. They will also watch a video demonstration on fit testing procedure.

Two types of N95 masks are selected for this project: 1) Halyard N95 Particulate Filter Respirators, and 2) ProShield® N-95 masks. Each participant will fit check and fit test both brands of the masks. The order of the N95 mask brand to be examined is randomly allocated.

The participant will don the first probed and randomised mask, and perform a user seal check in front of a mirror. A negative result means the wearer could not detect any gross leakage and will then proceed to the quantitative fit test with that mask.

The quantitative fit test involves the use of the Portacount machine, which will be calibrated at the beginning of each testing day, using a provided HEPA filter. The subject will attach their mask probe to the PortaCount machine via plastic tubing that has been soaked in 99.5% isopropyl alcohol solution. The test will then begin according to the United States Occupational Safety and Health Administration protocols (https://www.osha.gov/laws-regs/federalregister/2019-09-26), which consists of 4 exercises:
1) Bending over at the hips and returning to upright repeatedly, taking two breaths when bent over. This lasts 50 seconds.
2) Reading a standardized text aloud for 30 seconds
3) Moving the head from side to side for 30 seconds
4) Flexing and extending the neck for 39 seconds

The test will be observed throughout by personnel trained in the use of the PortaCount machine and any breach of protocol will be addressed by recommencing the test. At the conclusion of the test the subject will then disconnect and doff the mask.

The participant will then go through the same user seal check and quantitative fit tests as described above with the second brand of the N95 mask. The user seal check result and the fit factor for both brands of the N95 masks will be recorded.
Intervention code [1] 317628 0
Treatment: Devices
Comparator / control treatment
Halyard N95 mask
Control group
Active

Outcomes
Primary outcome [1] 323861 0
Fit test result - pass or fail.
Pass is defined as a fit factor of >100. The fit factor is calculated by dividing the concentration of the particles in ambient air outside the mask by that inside the mask.
It is assessed by a trained personnel using the PortaCount machine, which will be calibrated at the beginning of each testing day, using a provided HEPA filter. The subject will attach their mask probe to the PortaCount machine via plastic tubing that has been soaked in 99.5% isopropyl alcohol solution. The test will be performed according to United States Occupational Safety and Health Administration protocols (https://www.osha.gov/laws-regs/federalregister/2019-09-26).
Timepoint [1] 323861 0
At the time of fit testing
Secondary outcome [1] 383078 0
Fit check result - positive is when there is a leak, negative is when there is no leak detected.
To User Seal Check a respirator, the wearer should forcefully inhale and exhale several times. The respirator should collapse slightly upon inhaling and expand upon exhaling. The wearer should not feel any air leaking between his/her face and the respirator. This is the sign of a good facial fit and a successful User Seal Check.
Timepoint [1] 383078 0
At the time of fit checking
Secondary outcome [2] 383132 0
Fit test score - as measured by fit factor. The fit factor is calculated by dividing the concentration of the particles in ambient air outside the mask by that inside the mask.

It is assessed by a trained personnel using the PortaCount machine, which will be calibrated at the beginning of each testing day, using a provided HEPA filter. The subject will attach their mask probe to the PortaCount machine via plastic tubing that has been soaked in 99.5% isopropyl alcohol solution. The test will be performed according to United States Occupational Safety and Health Administration protocols (https://www.osha.gov/laws-regs/federalregister/2019-09-26).
Timepoint [2] 383132 0
At the time of fit testing
Secondary outcome [3] 383491 0
Comparing the accuracy of fit check with fit test results.
The accuracy of the user seal check will be scored against the fit factor. A fit factor of > 100 is considered a pass. The accuracy will be expressed as sensitivity=true positive/(true positive + false negative) and specificity=true negative/(true negative + false positive).
The fit check is assessed by user seal check technique as described by the manufacturer's user guide. The fit testing is assessed by using Portacount machine. The test will be performed according to United States Occupational Safety and Health Administration protocols (https://www.osha.gov/laws-regs/federalregister/2019-09-26).
Timepoint [3] 383491 0
At the time of fit check and fit test.

Eligibility
Key inclusion criteria
Anaesthetic staff members, including anaesthetic consultants and trainees who is currently working in the Royal Melbourne Hospital
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Currently experiencing respiratory symptoms
or
Have facial beard

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The order of the N95 mask brand to be examined is randomly allocated (www.random.org). The allocation will not be revealed until the time of testing begins.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The order of the N95 mask brand to be examined is randomly allocated (www.random.org). The randomisation will be stratified into two groups: 1) Asian and 2) Non-Asian. This is to minimise any variation in fit test success rate due to differences in ethnicity.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Stratification to Asian and non-Asian group.
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
There has been no studies evaluating the quantitative fit test passing rate of the Halyard N95 Particulate Filter Respirators and the ProShield® N-95 masks. However, based on Lam’s study, it shows that the quantitative fit passing rate among the three different tested N95 masks ranges between 0.45-0.7. Therefore if we assume the fit test passing rate of one type of mask to be 45% and the other type to be 70%, we will need about 70 participants in each group to provide a power of 0.8. Because this is a crossover trial, we will need a total of 70 participants. However, in order to account for dropouts or unexpected circumstances (such as equipment failure), we will recruit a total of 80 participants instead.

Descriptive statistics such as means, medians and percentages will be used to present the demographic data, user seal check results, and quantitative fit testing score and pass rate of both types of N95 masks. Paired t-test or Wilcoxon sign rank test will be used to compare the fit factor scores and passing rate between the two types of N95 masks depending on normality of the data distribution. A p-value of <0.05 is considered statistically significant. The accuracy of the user seal check will be scored against the fit factor. A fit factor of > 100 is considered a pass. The accuracy will be expressed as sensitivity=true positive/(true positive + false negative) and specificity=true negative/(true negative + false positive).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 16719 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 30321 0
3050 - Parkville

Funding & Sponsors
Funding source category [1] 305765 0
Hospital
Name [1] 305765 0
Department of Anaesthesia and Pain Management, Royal Melbourne Hospital
Address [1] 305765 0
Department of Anaesthesia and Pain Management
Office Level 3 North
Royal Melbourne Hospital
300 Grattan street
Parkville
Vic 3050
Country [1] 305765 0
Australia
Primary sponsor type
Hospital
Name
The Royal Melbourne Hospital
Address
Office for Research
Level 2 South West
Royal Melbourne Hospital
300 Grattan Street
Parkville Victoria 3050
Country
Australia
Secondary sponsor category [1] 306201 0
None
Name [1] 306201 0
Address [1] 306201 0
Country [1] 306201 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306039 0
Melbourne Health Research and Ethics Committee
Ethics committee address [1] 306039 0
Office for Research
Royal Melbourne Hospital
Level 2South West
300 Grattan Street
Parkville Victoria
Ethics committee country [1] 306039 0
Australia
Date submitted for ethics approval [1] 306039 0
11/05/2020
Approval date [1] 306039 0
25/05/2020
Ethics approval number [1] 306039 0
QA2020084

Summary
Brief summary
We are currently facing a global pandemic of COVID-19, caused by the novel coronavirus, SARS-CoV-2. Frontline healthcare workers, especially anaesthetic staff, are particularly vulnerable because of frequent performance of aerosolized-generated procedures, such as bag-mask ventilation and intubation. N95 filtering facepieces are recommended for use by healthcare workers who come into contact with airborne or aerosolized infectious diseases. The protection that is provided by these devices is dependent on the filter’s efficiency and seal quality. According to the recommendations by Standards Australian (AS/NZS 1715-2009), healthcare workers should undergo regular fit testing. Australian Guidelines for the Prevention and Control of Infection in Healthcare (2019) recognises that fit testing is a valuable practice, which provides an opportunity to educate healthcare professionals.

There are two types of N95 mask examinations — fit check and fit test. Fit checks, also known as the user seal checks, are fast and simple. It is performed by the wearer, who detects if a gross leak is present. Quantitative fit tests are more objective but require the use of specialised equipment by a trained operator. We would like to compare the fit testing results between the two types of N95 masks, namely the Halyard* N95 Particulate Filter Respirators and the ProShield® N-95 masks. There has been no published literature on the performance of these two types of masks. We would also like to compare the fit check with the fit testing results.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102510 0
Prof Daryl Williams
Address 102510 0
Department of Anaesthesia and Pain Management
Office Level 3 North
Royal Melbourne Hospital
300 Grattan Street
Parkville
Vic 3050
Country 102510 0
Australia
Phone 102510 0
+61 03 9342 7540
Fax 102510 0
Email 102510 0
Daryl.Williams@mh.org.au
Contact person for public queries
Name 102511 0
Dr Irene Ng
Address 102511 0
Department of Anaesthesia and Pain Management
Office Level 3 North
Royal Melbourne Hospital
300 Grattan Street
Parkville
Vic 3050
Country 102511 0
Australia
Phone 102511 0
+61 03 9342 7000
Fax 102511 0
Email 102511 0
Irene.Ng@mh.org.au
Contact person for scientific queries
Name 102512 0
Dr Irene Ng
Address 102512 0
Department of Anaesthesia and Pain Management
Office Level 3 North
Royal Melbourne Hospital
300 Grattan Street
Parkville
Vic 3050
Country 102512 0
Australia
Phone 102512 0
+61 03 9342 7000
Fax 102512 0
Email 102512 0
Irene.Ng@mh.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
To maintain participants' confidentiality
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary