Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000702910
Ethics application status
Approved
Date submitted
18/06/2020
Date registered
26/06/2020
Date last updated
26/06/2020
Date data sharing statement initially provided
26/06/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Fit testing of N95 filtering facepieces for anaesthetists and nurses treating COVID-19 patients
Scientific title
Fit testing of N95 filtering facepiece for anaesthetist and anaesthesia nurses managing endotracheal intubations in COVID19 patients
Secondary ID [1] 301569 0
Nil Known
Universal Trial Number (UTN)
U1111-1253-8286
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fit of N95 filtering facepiece/mask 317934 0
COVID-19 317966 0
Condition category
Condition code
Anaesthesiology 315967 315967 0 0
Anaesthetics
Infection 315968 315968 0 0
Other infectious diseases
Emergency medicine 315970 315970 0 0
Other emergency care
Public Health 315971 315971 0 0
Health promotion/education
Public Health 315972 315972 0 0
Health service research
Respiratory 316001 316001 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
At Austin Health, it is standard practice for the anaesthetist and anaesthesia nurse who are performing tracheal intubation on COVID19 patients to wear a N95 filtering facepiece (FFP). This protects the anaesthetist and nurse from small aerosolized particles and large droplets. To work effectively a N95 FFP must create a tight seal with the user’s face. However due to different facial characteristics, a tight seal may not be achieved with the brand of N95 FFP(BSN Medical Australia ProShield® N95 Medium and Small) that Austin Health is mandating.

Fit testing is a rigorous process performed by anaesthetist to ensure that the N95 FFP being used has the ability to form a tight seal. This process is mandatory in the USA and UK and is a requirement specified in Australian Standard AS/NZS 1715-2009. The fit testing method complies with the published protocol of OSHA (Occupational Safety and Health Administration, USA). As part of clinical governance, the Department of Anaesthesia is undertaking an observational study to evaluate fit testing for anaesthetists and anaesthesia nurses who are directly involved in performing tracheal intubation on COVID19 patients.

The fit testing be undertaken with a Portacount Respirator Fit Testing unit. This will ascertain whether the N95 FFP is safe for this high risk procedure. The primary aim of this study is to evaluate the failure rate of this N95 FFP in a group of anaesthetists and anaesthesia nurses. For those who are unable to be fitted with this brand of N95 FFP, alternative respiratory protective equipment will be provided.

Testing requires that the participants places the N95 FFP over their face, in the exact same way as they have been taught to apply the FFP. When the participant is satisfied that there is a tight seal with their face, the mask will be attached via a small plastic tube to the testing device. A strict testing protocol based on the OSHA (Occupational Safety and Health Administration, USA) will be applied. This involved the participant inhaling and exhaling normally, then rotating their heads to the left and right, and then bending forwards and straightening whilst breathing normally. Each participant will be tested once. The duration of the testing is approximately 15 minutes.

If an participant fails a test, education will be to ensure the mask is placed correctly by reinforcing the correct technique of mask fitting and subsequent re-testing will be done. A pass or fail will be scored for each test.
Intervention code [1] 317866 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324182 0
The primary aim is to evaluate the failure rate of N95 FFP in a group of anaesthetists and anaesthesia nurses. The outcome will be defined as a positive leak being detected using a Portacount Respirator Fit Testing unit. In this situation, the machine performing the measurement will display the word "fail". The outcome is binary i.e pass or fail.
Timepoint [1] 324182 0
The fit testing takes 15 minutes. The timepoint for completion of the test will be immediately after the test has been completed.
Secondary outcome [1] 383950 0
The proportion of participants who pass the fit testing after additional education. The outcome will be defined as a positive leak being detected using a Portacount Respirator Fit Testing unit. . In this situation, the machine performing the measurement will display the word "fail". The outcome is binary i.e pass or fail. The number of participants who fail the test will be reported as a proportion.
Timepoint [1] 383950 0
The fit testing takes 15 minutes. The timepoint for completion of the test will be immediately after the test has been completed. Education will take approximately 5 minutes and the participant will be retested. The outcome will be defined as a positive leak being detected. In this situation, the machine performing the measurement will display the word "fail". The outcome is binary i.e pass or fail.

Eligibility
Key inclusion criteria
Anaesthetists and anaesthesia nurses who are directly involved in performing tracheal intubation on COVID19 patients. To be included, eligible participants must first pass a fit check to be enrolled into this study, A successful pass for a fitness check requires the absence of a air leak during inhalation and exhalation with a N95 FFP in position over the face.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1.All personnel other than Anaesthetists and anaesthesia nurses who are not directly involved in performing tracheal intubation on COVID19 patients.
2. Anaesthetists and anaesthesia nurses who are directly involved in performing tracheal intubation on COVID19 patients who have been assessed as having a unsuccessful fit check and cannot be enrolled in this study.
An unsuccessful fit check implies the presence of an air leak during inhalation and exhalation with a N95 FFP in position over the face.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
All data will be presented as numbers (proportions), mean (standard deviations), or median (Interquartile range). Continuous data such as age, body mass index, height and weight will be tested for normal distribution using the D’Agostino-Pearson omnibus test. Comparisons between the proportion of participants who pass the test and those who do not will be done using Chi squared and fisher exact tests. Standard t-test (parametric and non parametric) will be used to determine whether the means or medians of any groups are equal to each other. The assumption for the test is that both groups are sampled from normal distributions with equal variances.A p value of <0.05 will be considered as significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/06/2020
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 16935 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 30593 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 306000 0
Hospital
Name [1] 306000 0
Austin Health
Country [1] 306000 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
Austin Health, Department of Anaesthesia
145 Studley Road
Heidelberg
Victoria, 3084
Country
Australia
Secondary sponsor category [1] 306460 0
None
Name [1] 306460 0
Address [1] 306460 0
Country [1] 306460 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306235 0
Austin Health Research Ethics Unit
Ethics committee address [1] 306235 0
Austin Health Research Ethics Unit
Austin Health
145 Studley Road
Heidelberg
Victoria, 3084
Ethics committee country [1] 306235 0
Australia
Date submitted for ethics approval [1] 306235 0
14/05/2020
Approval date [1] 306235 0
09/06/2020
Ethics approval number [1] 306235 0
HREC-39067

Summary
Brief summary
Study purpose:
The purpose of this study is to evaluate the failure rate of this N95 FFP in a group of anaesthetists and anaesthesia nurses.

At Austin Health, it is standard practice for the anaesthetist and anaesthesia nurse who are performing tracheal intubation on COVID19 patients to wear a N95 filtering facepiece (FFP). This protects the anaesthetist and nurse from small aerosolized particles and large droplets. To work effectively a N95 FFP must create a tight seal with the user’s face. However due to different facial characteristics, a tight seal may not be achieved with the brand of N95 FFP(BSN Medical Australia ProShield® N95 Medium and Small) that Austin Health is mandating. Fit testing is a rigorous process to ensure that the N95 FFP being used has the ability to form a tight seal. This process is mandatory in the USA and UK and is a requirement specified in Australian Standard AS/NZS 1715-2009. The fit testing method complies with the published protocol of OSHA (Occupational Safety and Health Administration, USA).

Who is it for?
This research involves fit testing for anaesthetists and anaesthesia nurses who are directly involved in performing tracheal intubation on COVID19 patients. This is a small team of highly trained and skilled medical personnel, who are charged with providing this specialised clinical service for all patients at Austin Health who require tracheal intubation.

Study details:
At a convenient time that does not impact on clinical care commitments; the participant will attend the department for fit testing. As per standard Austin Health guidelines for PPE training, all participants will have already undergone extensive training and education in donning the N95 FFP. Using the BSN Medical ProShield®N95 FFP size that has been assigned to the participant, a fit test will be performed using internationally accepted fit testing protocol. The fit test will be conducted using the TSI Portacount 8038/8048 machine. Participants who do not pass the fit test will be re-educated on how to put on the FFP using the ‘real time’ mode on the TSI Portacount machine. This will allow the user to see how different adjustments to the N95 FFP can affect the seal in real time. The participants who do not pass fit testing will be offered a different sized BSN Medical ProShield®N95 FFP and retested. '

If the participant is unable to be fitted with either of the BSN Medical ProShield®N95 FFP, an alternative FFP or elastometric respirator will be provided. The testing will be conducted in the Department of Anaesthesia. The duration of tetsing will be approximately 15 minutes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103198 0
A/Prof Laurence Weinberg
Address 103198 0
Department of Anesthesia, 145 Studley Road Heidelberg VIC 3084
Austin Health
Country 103198 0
Australia
Phone 103198 0
+61 3 94965000
Fax 103198 0
+61 3 94596421
Email 103198 0
[email protected]
Contact person for public queries
Name 103199 0
Dr Caitlin Low
Address 103199 0
Department of Anesthesia, 145 Studley Road Heidelberg VIC 3084
Austin Health
Country 103199 0
Australia
Phone 103199 0
+61 3 94965000
Fax 103199 0
+61 3 94596421
Email 103199 0
[email protected]
Contact person for scientific queries
Name 103200 0
Dr Caitlin Low
Address 103200 0
Department of Anesthesia, 145 Studley Road Heidelberg VIC 3084
Austin Health
Country 103200 0
Australia
Phone 103200 0
+61 3 94965000
Fax 103200 0
+61 3 94596421
Email 103200 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
Participants have not consented for individual participant data to be made available (including data dictionaries).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8276Study protocol  [email protected] 380035-(Uploaded-18-06-2020-17-19-24)-Study-related document.pdf
8301Ethical approval  [email protected]



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.