Proof-of-concept of the Measurement of Lung Function Using the Relaxed Expiratory Occlusion Monitor (REOM)

May 25, 2021 updated by: Thorasys Thoracic Medical Systems Inc.
(i) To validate the inversed occlusion technique by comparing the results of resistance obtained on the relaxed expiratory occlusion monitor (REOM) with the resistance obtained with respiratory oscillometry (OSC) measurements on the tremoflo® C-100 and (ii) explore (within-test and day-to-day) repeatability and responsiveness to change of this technique when used as home monitoring device in children with asthma.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Children will be evaluated for eligibility by telephone or videoconferencing. After eligibility and consent documented by email by parents and on a source document by the research assistant:

  1. Children will receive by courier one new REOM unit, a tablet with charger, and related disposables (nose clips etc.),

  2. At a videoconference planned at a mutually conveniently time with the child and their parents the following will be obtained;

    1. Basic demographics (date of birth, age, sex, ethnicity, height, weight) and asthma morbidity and medications.
    2. Training on the REOM unit measurement using a recorded instructions video, followed by hand-on use of the unit under remote observation. The Research Assistant will teach the parents and child in the REOM, namely on how to use the unit to measure resistance until it is mastered and reproducible, how to complete the brief daily questionnaire, and how upload data from the REOM to the tablet by Bluetooth. Confirmation of the validity and reproducibility of the technique will be obtained by review of the measurement output that will be sent by WIFI automatically from the tablet to a protected google drive (with the patient identified only by a code) accessible to the Coordinating Centre.
    3. Briefly, a minimum of three (3) reproducible measurements of Reo on the REOM will be obtained in accordance to the following standardized procedures: the subjects will be asked to be comfortably seated upright, with the head slightly tilted upward at an angle of about 15 degrees from neutral position to prevent upper airway obstruction, with the cheeks tightly supported to prevent upper airway shunting. A nose clip will be worn to prevent nasal air leak. Subjects will be instructed to breathe normally in a single-use bacterial/viral respiratory filter connected to the mouthpiece of the REOM device. This manoeuvre will be repeated for a maximum of 6 trials to obtain a coefficient of variation (CV) ≤15% on at least 3 Reo measurements with visual remote inspection of the curves and results via Bluetooth connection by the research assistant. Each trial will last 20 to 30 seconds to obtain a minimum of 3 to 6 valid expirations per trial. The mean Reo of 3 reproducible measurements will be calculated at the peak (Reo1) and the low (Reo2) flow.

  3. Once the technique is mastered, the child will be asked to:

    1. Perform the REOM measurements once daily before receiving their asthma controller medication, ideally at the same time in the evening.
    2. If the child requires a rapid beta-2 agonists because of symptoms, a before and after measurement will be obtained 30 minutes after the dose has been administered to document responsiveness to change once a day when sick.
    3. Once a week, a short questionnaire including the cACT (or ACT for 12 years and older), a question about an acute care visit or use of rescue oral corticosteroids, and occurrence of any adverse event will be sent by text message or email (patient preference) throughout the study duration.
  4. A research assistant will contact the family at 7±3 days, 14±3 days, and monthly thereafter or, if in case of problem with the equipment or interruption in REOM measurements/response to the weekly questionnaire.

The study duration will be 4 months (to maximize the chance of an exacerbation).

Study Type

Observational

Enrollment (Anticipated)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H3T 1C5

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The asthmatic study subjects will be recruited a the Sainte-Justine University Hospital Center, Montreal, QC. Recruitment will be performed by Dr. Ducharme's research staff. The study will be conducted remotely with patients who consented to the Pediatric asthma database and Biobank of the Sainte-Justine University Hospital Center or among the families subscribing to the Asthma Clinic newsletter or seeing the advertisement on the CHUSJ website.

Description

Inclusion Criteria:

  1. Children aged between 6 and 17 years old
  2. Adequate understanding of French or English
  3. Asthma diagnosis confirmed by a physician

  4. Poor asthma control in the past 6 months, that is,

    1. an acute exacerbation requiring oral corticosteroids, or
    2. an FEV1 <80% of predicted, FEV1/FVC ratio below the lower limit of normal, or significant (≥12%) reversibility in FEV1, or
    3. a total score <20 on the child Asthma Control Test (ACT) for children aged ≤11 years or on the ACT for those aged ≥12 years).

Exclusion Criteria:

  1. Inability to produce a good seal around the mouthpiece when previously tested with spirometry
  2. Oscillometry or REOM, contra-indication to performing respiratory tests (e.g., facial trauma, chest pain, severe scoliosis)
  3. Other reason interfering with respiratory testing.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory resistance R5
Time Frame: Over one week
Using the tremoflo C-100 at 5 Hz to calculate the mean resistance during the patient's tidal breathing.
Over one week
Expiratory resistance (R5exp)
Time Frame: Over one week
Using the tremoflo C-100 at 5 Hz to calculate resistance during the patient's exhalation.
Over one week
Resistance at low expiratory flow (Reo2)
Time Frame: Over one week
Using the REOM device the resistance (Reo2) at low expiratory flow will be calculated.
Over one week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory resistance R19
Time Frame: Over one week
Using the tremoflo C-100 at 19 Hz to calculate the mean resistance during the patient's tidal breathing.
Over one week
Expiratory resistance (R19exp)
Time Frame: Over one week
Using the tremoflo C-100 at 19 Hz to calculate resistance during the patient's exhalation.
Over one week
Resistance at high expiratory flow (Reo1)
Time Frame: Over one week
Using the REOM device the resistance (Reo1) at high expiratory flow will be calculated.
Over one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thorasys Thoracic Medical Systems Inc.

Collaborators

MedTeq

Investigators

  • Principal Investigator: Francine M Ducharme, MD, St. Justine's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

June 1, 2021

Primary Completion (ANTICIPATED)

May 1, 2022

Study Completion (ANTICIPATED)

October 1, 2022

Study Registration Dates

First Submitted

May 19, 2021

First Submitted That Met QC Criteria

May 25, 2021

First Posted (ACTUAL)

May 26, 2021

Study Record Updates

Last Update Posted (ACTUAL)

May 27, 2021

Last Update Submitted That Met QC Criteria

May 25, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REOM 2019-2053

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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