Australian Central Over-Reading Centre

The Australian Central Over-Reading Centre (CORC) specialises in training and supporting operators to become certified to perform multiple breath washout (MBW) and oscillometry testing.

The Australian CORC also provides over-reading services for data collected during clinical trials and investigator-led studies. The Australian CORC is based at the Child Health Research Centre (CHRC) in Brisbane, Australia.

Multiple Breath Washout (MBW) Certification and training

The Multiple Breath Nitrogen Washout test has been identified as a promising modality for evaluating the efficacy of new treatments for several important paediatric and aduolt obstructive lung diseases. The Australian CORC network was formed to facilitate successful implementation of MBW into clinical trial and investigator-led studies across multiple sites nationally and internationally as part of an international CORC network in collaboration with SickKids Hospital in Toronto, Canada and the Royal Brompton Hospital in London, England. Collectively these three centres cover the geographic regions of Australia/New Zealand, North America and Europe, respectively.

The Australian CORC network provides a platform for MBW training according to a standardised MBW testing protocol and qualification program using the Exhalyzer® D MBW device. We provide hands-on in-person training and/or virtual training (depending on the needs of the study), operator qualification and support for new operators through 1:1 help sessions.

Please contact the Australian CORC for any questions regarding these MBW-based services via the email below:

mbwcentre@uq.edu.au

Oscillometry Certification and training

The oscillometry test has been identified as a promising modality for evaluating individual’s airway function and found to be more sensitive than spirometry in the detection of peripheral airway diseases. As it is a relaxed, tidal breathing-based manoeuvre it can be greatly utilised in those where spiriometry is more challenging to perform i.e., children, the elderly and those with neuromuscular weaknesses.

The Australian CORC network was formed to facilitate successful implementation of oscillometry into clinical trial and investigator-led studies across multiple sites nationally and internationally.

The Australian CORC network provides a platform for oscillometry training according to a standard oscillometry testing protocol and qualification program using the tremoflo® C2 and C100 devices. We provide hands-on in-person training or virtual training, operator qualification and support for new operators through 1:1 help sessions. We also provide central over-reading services for data collected within studies, tailored to the needs of the study.

Please contact the Australian CORC for any questions regarding these oscillometry-based services via the email below:

oscillometrycentre@uq.edu.au

Professor Paul Robinson

Conjoint Professor in Respiratory and Sleep Medicine

Child Health Research Centre
Dr Tamara Blake

Research Fellow (Respiratory Physiology) & Respiratory Scientist

Child Health Research Centre
Miss Kathleena Condon

Casual Research Assistant & Senior Clinical Research Assistant

Child Health Research Centre

Training documents

Standard operating procedure

This SOP is intended as an operator’s guide to Nitrogen Multiple Breath Washout Testing using the Eco Medics AG Exhalyzer® D Pulmonary Function Testing Device with online testing software Spiroware 3.1.6. Version: Jun 28 2017

Download

Download (MBWN2 SOP v1.1_3.3.2 Supplement)

MBW Training and qualification requirements

This document is intended to assist MBW training participants with their Multiple Breath Nitrogen Washout qualifications.

Download

Time of test documents

Defining a leak

This document is intended to help operators identify leaks during the multiple breath nitrogen washout test.

Download

MBW System error messages summary

This summary provides a table of the error messages from the EcoMedics Exhalyzer D system and its description.

Download

MBW testing checklist

This testing checklist provides a list of reminders for operators before beginning their MBW testing.

Download

Intake sheet form

The MBW N2 intake sheet form provides MBW operators a checklist during time of test to review quality of trials. It also allows operators to keep track on the number of acceptable trials within a test occasion.

Download

Post test documents

Signal misalignment SOP

This document is intended to help operators identify signal alignment issues. Signals must be aligned in order to generate accurate MBW outcomes. Version: Aug 10 2016

Download

General re-run instructions

Re-running A-files allows the operator the opportunity to correct any system settings that were incorrect when the data was acquired. Version: May 31 2016

Download

Do I need to attend the MBW training in person?

Anyone who will be performing MBW testing for a sponsored study (i.e. PROSPECT, SHIP, Vertex etc.) MUST attend a one-day training session and complete qualification requirements.
An experienced operator can train new staff on-site if they have completed 50 test occasions with an 80% success rate. It is the responsibility of the operator to collect the QC reports and demonstrate they have fulfilled the requirements to the MBW centre prior to training new staff.
Operators who are training by a team member on-site are required to complete the Post-training knowledge test (80% pass mark required), and demonstrate the ability to perform technically acceptable MBW tests. It is also recommended that these operators complete the Pre-training modules.
Please download the MBW Training and Certification Requirements document in the MBW Resources section for further details.

How do I become a qualified MBW operator for adults and children (6+ years)?

Operators must first attend a training, then submit MBWN₂ qualification tests to the Centre for review. Once qualification tests are deemed successful (with an 80% success rate), this operator will be considered qualified for MBWN₂ testing in subjects 6 years and older.
The subjects asked to perform MBWN₂ for your qualifications should be representative of the study population. Hence, if you are from a paediatric site, at least 1 paediatric patient should be included in your qualifications.
It is up to the site to ensure they have appropriate research ethics approvals to test subjects for certification.
To complete the certification process, the Post-training knowledge test must also be completed.
Please download the MBW Training and Certification Requirements document in the MBW Resources section for further details.

How do I become qualified in MBW testing for preschoolers (3-6 years)?

The operator must have attended a training, have completed the online pre-school training module and be certified in MBWN₂ testing for adults and children (6+ years).
Preschool testing requires 2 operators at the time of test; thus both operators must submit a total of 5 preschool qualification tests to the Centre for review. Both operators wishing to become certified in preschool testing must be present at the test. Once qualification tests are deemed successful (with an 80% success rate), both operators will be considered qualified for MBWN₂ testing in preschool children.

How many test occasions must be submitted per operator for adult and children (6+ years) MBW qualification?

For a new site to become qualified in MBW testing for subjects 6 years and above, at least 10 test occasions must be submitted for site qualification. If there is a single operator, they must submit 10 test occasions. If there are multiple operators, each operator must submit 5 test occasions.
For any additional operator at a qualified site, the new operator must submit 5 test occasions.
Each operator should include at a minimum: 2 CF patients and 1 subject must be in the range of the study population (e.g. at paediatric centres)
Please download the MBW Training and Qualification Requirements document in the MBW Resources section for further details.

How many test occasions must be submitted per operator for preschool MBW qualification?

Qualification tests for adults and children (6+ years) should be submitted and approved by the MBW centre before preschool qualification measurements are collected.
Sites participating in a preschool study are SUBSEQUENTLY required to send an additional 5 test occasions from preschool children (3-6 years of age).
Subjects tested for qualification should be representative of study population and sites should aim to test as many subjects belonging to this group as possible. Sites must include at a minimum: 2 children with CF and one child <4 years
Please download the MBW Training and Qualification Requirements document in the MBW Resources section for further details.

Once my site is qualified for preschool testing, can I have someone who is not trained hold the mask?

In our experience it is beneficial for both operators performing MBW testing in preschool children to be certified and experienced in testing. However, we understand there are extenuating circumstances when two certified operators are not available. In this event an inexperienced member of the team may hold the mask. **PLEASE NOTE this does NOT apply to qualification testing. It is recommended that sites participating in preschool studies have at least 3 operators trained to ensure trained operators are available for all study visits.

Who will be qualified; the site or the individual?

Can operators submit study data in the place of qualification test occasions?

Operators cannot submit study data in place for their qualification test occasions. Operators must demonstrate that they can collect original, technically acceptable data as the primary operator (Subjects < 6years) or on their own (Subjects > 6years). Data will be collected under unique qualification ID’s, solely for the purpose of operator certification.
Please download the MBW Training and Certification Requirements document in the MBW Resources section for further details

Where do I get consumables for the qualification test occasions?

Consumables required to test subjects >6 years of age for the certification protocol come standard with the purchase of the equipment. For further information see the MBW SOP for details (this is available once you register for training). For qualifications, a generic mouthpiece may be used and the filter used for testing is available through Eco Physics. Please note, there are study specific consumables that must be used when collecting study data.
Consumables required to test subjects <6 years of age for the qualification protocol will be provided to you either by the MBW centre during training or by the CRO after training, this will depend on the study.
Please recall: Qualification MBW tests for testing subjects (>6 years old) should be collected, submitted AND DEEMED successful prior to collection of preschool qualification tests.

Multiple Breath Washout (MBW) Certification and training

Oscillometry Certification and training

Professor Paul Robinson

Dr Tamara Blake

Miss Kathleena Condon

Training documents

Time of test documents

Post test documents

Do I need to attend the MBW training in person?

How do I become a qualified MBW operator for adults and children (6+ years)?

How do I become qualified in MBW testing for preschoolers (3-6 years)?

How many test occasions must be submitted per operator for adult and children (6+ years) MBW qualification?

How many test occasions must be submitted per operator for preschool MBW qualification?

Once my site is qualified for preschool testing, can I have someone who is not trained hold the mask?

Who will be qualified; the site or the individual?

Can operators submit study data in the place of qualification test occasions?

Where do I get consumables for the qualification test occasions?

How do I get a username and password to transfer data via FTP?