WHAT WE DO

The Multiple Breath Washout (MBW) test has been identified as promising outcome for evaluating the efficacy of new treatments. In order to standardize testing for interventional studies, our team has developed a standard protocol and qualification program. As the North American MBW training centre, we provide hands-on training sessions, operator qualification and support for new operators. If you are interesting in attending training, or require quality control over-reading services for your clinical trial, please contact our team below.

MBW TRAINING

Our team has developed an intensive MBW training and qualification process based on the MBWN2 Standard Operating Procedure to facilitate standardized data collection for multi-centre clinical trials. The training session is designed to facilitate making real-time decisions about test quality. The training components include:

  1. Pre-Training – Online Learning
    • Prior to attending the one-day session participants are encouraged to complete the online Pre-Training
    • Pre-Training Quiz
  2. One-day Hands-on Session
    • Session provides hands-on application and practical training to learn how to conduct quality MBW testing
  3. Post-Training – Qualification Process
    • Participants are required to complete the online Post-Training Module and Knowledge Test
    • Participants are required to collect/submit MBW Qualification Tests
Peter Gilgan Centre for Research and Learning SickKids, Toronto
Peter Gilgan Centre for Research and Learning (SickKids), Toronto

UPCOMING TRAINING

Operators who will perform MBW measurements on clinical trial study participants should attend a one-day in person MBW training session. Please click onto the upcoming dates below for registration.

ONLINE TRAINING MODULES

The online training modules are a fundamental compoenent of the MBW training process. The Pre-Training module provides background information about MBW and the Exhalyzer D® device. The Post-Training consists of additional learning modules and a Knowledge Test. Please access the online training modules by clicking the icon below. The online training content is password protected.

MBW RESOURCE 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

  • MBW Training and Qualification Requirements

    This document is intended to assist MBW training participants with their Multiple Breath Nitrogen Washout qualifications. Version: Apr 21 2017

    Download

  • Defining a Leak

    This document is intended to help operators identify leaks during the multiple breath nitrogen washout test. Version: May 26 2016

    Download

  • MBW System Error Messages Summary

    This summary provides a table of the error messages from the EcoMedics Exhalyzer D system and its description. Version: Oct 19 2015

    Download

  • MBW Testing Checklist

    This testing checklist provides a list of reminders for operators before beginning their MBW testing. Version: Oct 19 2015

    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. Version: Mar 20 2017

    Download

  • 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

FREQUENTLY ASKED QUESTIONS

Do I need to attend the MBW training in Toronto?

  • Anyone who will be performing MBW testing for a sponsored study (i.e. PROSPECT, SHIP, Vertex etc.) MUST attend a one-day training session in Toronto 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.
  • For operators trained at their own site who have not attended training, the cost of knowledge test administration and certification is $400.00 CAD per submission. All of the same qualification requirements apply.
  • Please download the MBW Training and Certification Requirements document in the MBW Resources section for further details.

How do I register for the training session?

  • For information about our training sessions and registration, visit our MBW Centre website.
  • For additional information about training, please contact the study CRO or the MBW Centre (mbw.centre@sickkids.ca).

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 (see question 5) to the MBW 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 MBW 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?

  • Individuals within each site will be certified to perform MBW for the sponsored studies. If new individuals join the team and will perform MBW measurements, they must attend training and successfully collect and submit the requisite number of test occasions before they can test study participants.

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.

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

  • Please contact the study specific CRO to request an FTP account. The request for FTP accounts will be processed weekly, usually on Fridays.

Who do I contact for MBW related questions?

  • After you have attended the training session, the MBW Centre is happy to answer your MBW procedural related questions and have a 1:1 help session, please contact us at mbw.centre@sickkids.ca.
  • If you have questions regarding the operation of your MBW unit (i.e. error messages, malfunction, software problems), please contact EcoPhysics (Tom McKarns tom@ecophysics-us.com) directly for equipment related support.

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