MBW Centre

Photo of child doing MBW mask

The Multiple Breath Washout (MBW) test has been shown to be an effective tool for monitoring progression of cystic fibrosis (CF) lung disease and evaluating the efficacy of new treatments. In order to standardize testing for clinical trials, our team has developed a standard protocol and qualification program.

As the North American (NA) National Resource Centre (NRC) & Central Over-Reading Centre (CORC), we provide hands-on MBW training sessions, operator qualification and support for new operators. If you are interested in attending training or require quality control over-reading services for your clinical trial, please contact our team.

MBW Training

Our team has developed an intensive MBW training and qualification process based on a device specific MBW N₂ 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 hands-on session participants are required to complete three online training modules and a pre-training quiz.

2.

One-day Hands-on Session:
This 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 a final online post-training module and knowledge test. Upon successful test completion, participants are required to collect/submit MBW qualification tests.

Participants are required to complete a final online post-training module and knowledge test. Upon successful test completion, participants are required to collect/submit MBW qualification tests.

Trainees will independently review online training modules, attend an in-person training session in Toronto hosted by the NA CORC and successfully collect qualification tests to obtain operator qualification. While most of the training can be conducted remotely, sites must also have in-person access to their Exhalyzer® D MBW device.

The training program is comprised of five components which should be performed in series and completed over several weeks. Further details for each component can be found in the registration link.

MBW Training Registration 2025

MBW Resource Documents

1. 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 and Spiroware testing software.

2. North American MBW Training and Qualification Requirements (PDF)
This document is intended to assist MBW training participants with their Multiple Breath Nitrogen Washout qualifications.
Version: Nov 7, 2024

1. Defining a Leak (PDF)
This document is intended to help operators identify leaks during the multiple breath nitrogen washout test.
Version: May 26, 2016

2. MBW Testing Checklist (PDF)
This testing checklist provides a list of reminders for operators before beginning their MBW.
Version: Feb 9, 2024

3. MBW System Error Messages Summary (PDF)
This summary provides a table of the error messages from the EcoMedics Exhalyzer D system and its description.
Version: Oct 19, 2015

4. Intake Sheet Form (PDF)
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: June 20, 2017

1. 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.

2. General Re-Run Instructions

Frequently Asked Questions

  • Anyone who will be performing MBW testing for a sponsored study (i.e. PROMISE, BEGIN, Vertex, etc.) must attend a one-day training session in Toronto and complete qualification requirements.
  • If there is substantial reasoning as to why specific personnel cannot attend training session hosted by NA CORC, 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. Please connect with the NA MBW Centre before proceeding with this alternative training option.
    • Operators who are trained by a team member are required to complete the Post-Training Knowledge Test (80% pass mark required) and demonstrate the ability to perform technically acceptable MBW tests by collecting and submitting qualification tests to the NA CORC. It is also recommended that these operators complete the Pre-Training modules.
    • For operators trained at their own site who have not attended training, knowledge test administration and qualification is still required. All the same qualification requirements apply. Operators will still need to pay the qualification training cost associated with MBW qualification.
  • Please download the MBW Training and Qualification Requirements document in the MBW Resource Documents section for further details.

  • For information about our training sessions and registration, visit our Training section on this page.
  • For additional information about training, please contact the study CRO or the MBW Centre.

  • Operators must first attend a training, then submit MBW N₂ 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 MBW N₂ testing in subjects 6 years and older.
  • The subjects asked to perform MBW N₂ for your qualifications should be representative of the study population. Hence, if you are from a paediatric site, at least one paediatric patient should be included in your qualifications.
  • It is the responsibility of the site to ensure they have appropriate research ethics approvals to test subjects for qualification.
  • To complete the qualification process, the Post-Training Knowledge Test must also be completed.
  • Please download the MBW Training and Qualification Requirements document in the MBW Resources section for further details.

  • The operator must have attended a training, have completed the online pre-school training module and be qualified in MBW N₂ testing for adults and children (6+ years).
  • Preschool testing requires two operators at the time of test; thus, two operators working together must submit a total of five qualification tests to the MBW Centre for review. Both operators wishing to become qualified 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 MBW N₂ testing in preschool children.

  • For a new site to become qualified in MBW testing for subjects 6 years and above, a total of five qualification tests should be performed by each operator wishing to be qualified. For any additional operator at a qualified site, the new operator must submit five test occasions.
  • Each operator should include at a minimum: two CF patients and one 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.

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

  • Individuals within each site will be qualified 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.

  • 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 younger than 6 years of age) or on their own (subjects over 6 years of age). Data will be collected under unique qualification IDs, solely for the purpose of operator qualification.
  • Please download the MBW Training and Qualification Requirements document in the MBW Resources section for further details.

  • Qualification tests for adults and children (over 6 years of age) 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 (2–6 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 less than 4 years of age.
  • Please download the MBW Training and Qualification Requirements document in the MBW Resources section for further details.

  • Consumables required to test subjects over 6 years of age for the qualification 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 EcoPhysics. Please note, there are study specific consumables that must be used when collecting study data.
  • Consumables required to test subjects less than 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 (over 6 years of age) should be collected, submitted and deemed successful prior to collection of preschool qualification tests.

  • 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 through our Contact Us page.
  • If you have questions regarding the operation of your MBW unit (i.e. error messages, malfunction, software problems), please contact EcoPhysics (TJ Baker at TJ@ecophysics-us.com) directly for equipment related support.