We are experiencing 4 week turn-around time in review of submissions and resubmissions. We recommend commencing this process concurrently with your ethics submission and allowing at least 8 weeks for registration to be completed from date of first submission. We currently do not have the capacity to expedite reviews.

Note also there are delays to review of updates. We appreciate your patience.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12621000065897p
Ethics application status
Submitted, not yet approved
Date submitted
27/10/2020
Date registered
27/01/2021
Date last updated
27/01/2021
Date data sharing statement initially provided
27/01/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
An investigation of fit testing of face masks in a real world intensive care setting during the COVID-19 pandemic
Scientific title
An investigation of fit test rates of N95 respirators after four hours of use in a real world intensive care setting during the COVID-19 pandemic.
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 four hours later in a real world ICU setting, to assess fit testing rates after four 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
3M 1860s mask size small
BYD CARE Foldable N95 Particulate Respirator (“one-size fits all”) BYD DE2322. 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. Participants who fail at the four hour test may re-enter the study from the following day onwards using a different N95 respirator.
Fit testing is expected to take around 30 minutes per participant.

In addition quantitative fit testing has recently been introduced to our hospital (external to this study), using the Porta-Count device and international validated protocols. Where results from this are available and shared with us by the study participants this was to be compared to qualitative fit testing (see outcomes section).
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 four 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 after four hours use
Secondary outcome [1] 388299 0
Sensitivity of qualitative with quantitative fit testing (if possible). Using quantitative fit testing as the gold standard.
Timepoint [1] 388299 0
At baseline only
Secondary outcome [2] 388436 0
Composite outcome. Ease of establishing fit testing regimen within the ICU setting during a pandemic. Measured by study specific questionnaire asked to the investigators and department heads. In addition time to fit test will be measured for each participant, plus any issues arising during the project/during fit tests will be noted and reported. Time to perform will be calculated from timestamps (eg time participant consented, time study started, time completed) recorded throughout study. Issues will be noted on same electronic form
Timepoint [2] 388436 0
End of study for questionnaire and ongoing throughout for time to fit test.
Secondary outcome [3] 388437 0
Comparison of the fit test pass and fail rates between the available respirator designs.
Timepoint [3] 388437 0
Baseline and at four hours.
Secondary outcome [4] 390942 0
Specificity of qualitative with quantitative fit testing (if possible). Using quantitative fit testing as the gold standard.
Timepoint [4] 390942 0
Baseline only

Eligibility
Key inclusion criteria
1) All healthcare workers in patient facing role working with the study ICUs
2) Where HCWs had failed the 4 hour test they were permitted to re-enter the study using a different design of N95
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) Participants who were unable to complete both baseline and four hour repeat testing without leaving the ICU were excluded, as this would not represent work within the ICU and they were unable to be observed by ICU ‘PPE spotters’
2) Any participants who looking after COVID-19 suspected or confirmed patients on that day were excluded due to the risk of spreading infection to testers/other staff on re-testing
3) Any male participants with greater than three days growth of facial hair in the mask seal area, as they were unlikely to have a good mask seal
4) Any participants with current respiratory symptoms
5) Any participants who did not consent to the study

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
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

Funding & Sponsors
Funding source category [1] 307063 0
Hospital
Name [1] 307063 0
Monash Health
Address [1] 307063 0
Monash Health
246 Clayton Road,
Clayton,
VIC.
3168
(In-kind support)
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] 281523 0
Individual
Name [2] 281523 0
John D Y Lee
Address [2] 281523 0
Intensive Care Unit
Casey Hospital
62-70 Kangan Drive
Berwick
VIC
3806
Country [2] 281523 0
Australia

Ethics approval
Ethics application status
Submitted, not yet 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

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
Department of Intensive Care Unit
Casey hospital, Monash Health
62 - 70 Kangan Drive
Berwick
Vic 3806
Country 106330 0
Australia
Phone 106330 0
+61 3 8768 2670
Fax 106330 0
Email 106330 0
samuel.reade@monashhealth.org
Contact person for public queries
Name 106331 0
Dr Samuel Reade
Address 106331 0
Department of Intensive Care Unit
Casey hospital, Monash Health
62 - 70 Kangan Drive
Berwick
Vic 3806
Country 106331 0
Australia
Phone 106331 0
+61 3 8768 2670
Fax 106331 0
Email 106331 0
samuel.reade@monashhealth.org
Contact person for scientific queries
Name 106332 0
Dr Samuel Reade
Address 106332 0
Department of Intensive Care Unit
Casey hospital, Monash Health
62 - 70 Kangan Drive
Berwick
Vic 3806
Country 106332 0
Australia
Phone 106332 0
+61 3 8768 2670
Fax 106332 0
Email 106332 0
samuel.reade@monashhealth.org

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 other documents available
Summary results
No Results