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Trial registered on ANZCTR


Registration number
ACTRN12620000709943
Ethics application status
Approved
Date submitted
25/05/2020
Date registered
29/06/2020
Date last updated
29/06/2020
Date data sharing statement initially provided
29/06/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing user seal check and fit test between a new and a decontaminated N95 respirator.
Scientific title
Comparing user seal check and fit test between a new and a decontaminated N95 respirator.
Secondary ID [1] 301361 0
nil
Universal Trial Number (UTN)
u1111-1252-4449
Trial acronym
nil
Linked study record
nil

Health condition
Health condition(s) or problem(s) studied:
nil 317592 0
Condition category
Condition code
Other 315674 315674 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Using the participants best fitted N95 mask, it will be checked to ensure it is not visually damaged or soiled, and then place it in a sealed Tyvek pouch for decontamination. We will follow the instructions as per STERIS Healthcare on “Decontamination of Compatible N95 Respirators Using the STERIS Sterilization Systems".

60 individuals who have completed a successful fit test with their best-fitted mask will be invited to take part. Their best-fitted mask will be labelled with a study identification number. They have to wear the mask for one hour, check it is not visually damaged or soiled, and then place it in a sealed Tyvek pouch for decontamination. The instructions as per STERIS Healthcare on “Decontamination of Compatible N95 Respirators Using the STERIS Sterilization Systems” will be followed. After completion of one cycle of decontamination, we will inspect the masks and discard the ones with obvious structural damage or deformity. They will be counted as not fit-for-purpose. Using those without any damage or deformity, the participants will then carry out a user seal check and a quantitative fit test. They will provided with, 1) their own best-fitted N95 mask which has been through one cycle of H2O2 decontamination, 2) a new N95 mask with the same brand and size. Both masks will have their study identification number labeled and placed in a plastic bag. 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. The user seal check result and the fit factor for both new and decontaminated N95 masks will be recorded.
Intervention code [1] 317661 0
Not applicable
Comparator / control treatment
A fit test and user seal check will be conducted on a new N95 mask,
Control group
Active

Outcomes
Primary outcome [1] 323908 0
Fit test results - passing rate (defined as fit factor >100)
Timepoint [1] 323908 0
At point of the fit test
Secondary outcome [1] 383292 0
User seal check results – positive (gross leak) or negative (no leak)
Timepoint [1] 383292 0
During the user seal check test
Secondary outcome [2] 383306 0
Fit testing result – fit factor scores
Timepoint [2] 383306 0
At time of fit testing
Secondary outcome [3] 383307 0
Number of masks not fit-for-purpose after decontamination (ie. with structural damage or deformity)
Timepoint [3] 383307 0
At time of mask inspection after decontamination

Eligibility
Key inclusion criteria
Anaesthetic staff members, including anaesthetic consultants and trainees will be invited to participate who have recently passed their quantitative fit test with their best-fitted N95 masks
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Individuals with current respiratory symptoms or facial beard.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Descriptive statistics such as means, medians and percentages will be used to present the demographic data, number of not fit-for-purpose masks, user seal check results, and quantitative fit testing score and pass rate of both new and decontaminated N95 masks. Paired t-test or Wilcoxon sign rank test will be used to compare the fit factor scores (depending on normality of the data distribution), and chi square test will be used to compare the passing rate between the two groups. A p-value of <0.05 is considered statistically significant.


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/07/2020
Actual
Date of last participant enrolment
Anticipated
6/07/2020
Actual
Date of last data collection
Anticipated
6/07/2020
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 30376 0
3050 - Royal Melbourne Hospital

Funding & Sponsors
Funding source category [1] 305802 0
Hospital
Name [1] 305802 0
The department of Anaesthesia and Pain management - The Royal Melbourne Hospital
Country [1] 305802 0
Australia
Primary sponsor type
Hospital
Name
The department of Anaesthesia and Pain management - The Royal Melbourne Hospital
Address
300 Grattan Street, Parkville, Victoria 3050
Country
Australia
Secondary sponsor category [1] 306544 0
None
Name [1] 306544 0
Address [1] 306544 0
Country [1] 306544 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306073 0
The Melbourne Health Human Research Ethics Committee - Quality Assurance Committee
Ethics committee address [1] 306073 0
300 grattan street, parkville, Victoria 3050
Ethics committee country [1] 306073 0
Australia
Date submitted for ethics approval [1] 306073 0
15/05/2020
Approval date [1] 306073 0
27/05/2020
Ethics approval number [1] 306073 0

Summary
Brief summary
The study aim is to compare the user seal check and fit test between new and decontaminated N95 respirator. Institutions around the world have explored the options of decontamination and reuse of N95 respirators. Current literature has shown promising results with the use of aerosolised or vapour-phase H2O2 to decontaminate N95 masks. Although multiple studies have been done, there are only a few studies which evaluated fit testing of the decontaminated respirators. Most of these studies tested on a small sample size. We believe quantitative fit testing on a larger group of individuals is essential. This will ensure that tight seal can be maintained on healthcare workers with different facial features after H2O2 decontamination of the N95 masks.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102602 0
Prof Daryl Williams
Address 102602 0
Department of Anaesthesia and Pain Management, Royal Melbourne Hospital, 300 Grattan St. Parkville, Victoria 3050
Country 102602 0
Australia
Phone 102602 0
+613 9342 7540
Fax 102602 0
Email 102602 0
[email protected]
Contact person for public queries
Name 102603 0
Irene Ng
Address 102603 0
Department of Anaesthesia and Pain Management, Royal Melbourne Hospital, 300 Grattan St. Parkville, Victoria 3050
Country 102603 0
Australia
Phone 102603 0
+613 9342 7540
Fax 102603 0
Email 102603 0
[email protected]
Contact person for scientific queries
Name 102604 0
Irene Ng
Address 102604 0
Department of Anaesthesia and Pain Management, Royal Melbourne Hospital, 300 Grattan St. Parkville, Victoria 3050
Country 102604 0
Australia
Phone 102604 0
+613 9342 7540
Fax 102604 0
Email 102604 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
n/a


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.