Asthma in ChildrenNCT04903145
Proof-of-concept of the Measurement of Lung Function Using the Relaxed Expiratory Occlusion Monitor (REOM)
An observational study of Asthma in Children, run by Thorasys Thoracic Medical Systems Inc. at 1 site in Canada.
Trial summary
(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… Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Asthma in Children
- What is being tested?
- REOM
- How many people
- 45 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2021to Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Children aged between 6 and 17 years old
- Adequate understanding of French or English
- Asthma diagnosis confirmed by a physician
- Poor asthma control in the past 6 months, that is,
- an acute exacerbation requiring oral corticosteroids, or
- an FEV1 <80% of predicted, FEV1/FVC ratio below the lower limit of normal, or significant (≥12%) reversibility in FEV1, or
- 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).
Who cannot join
- Inability to produce a good seal around the mouthpiece when previously tested with spirometry
- Oscillometry or REOM, contra-indication to performing respiratory tests (e.g., facial trauma, chest pain, severe scoliosis)
- Other reason interfering with respiratory testing.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Sainte-Justine University Hospital Center
Montreal, Quebec, H3T 1C5
Francine M Ducharme, MD, 514 345-4931 ext. 4398, francine.m.ducharme@umontreal.ca
About this study
(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.
Read the 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:
- Children will receive by courier one new REOM unit, a tablet with charger, and related disposables (nose clips etc.),
- At a videoconference planned at a mutually conveniently time with the child and their parents the following will be obtained;
- Basic demographics (date of birth, age, sex, ethnicity, height, weight) and asthma morbidity and medications.
- 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.
- 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.
- Once the technique is mastered, the child will be asked to:
- Perform the REOM measurements once daily before receiving their asthma controller medication, ideally at the same time in the evening.
- 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.
- 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.
- 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).
- Conditions
- Asthma in Children
- Being tested
- REOM
- Keywords
- tremoflo, oscillometry, interrupter, asthma, REOM
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REOMDiagnostic test
To compare data generated by the REOM device with data from the tremoflo C-100 device
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory resistance R5
Using the tremoflo C-100 at 5 Hz to calculate the mean resistance during the patient's tidal breathing.
Measured: Over one week
Expiratory resistance (R5exp)
Using the tremoflo C-100 at 5 Hz to calculate resistance during the patient's exhalation.
Measured: Over one week
Resistance at low expiratory flow (Reo2)
Using the REOM device the resistance (Reo2) at low expiratory flow will be calculated.
Measured: Over one week
Secondary outcomes (3)
Respiratory resistance R19
Using the tremoflo C-100 at 19 Hz to calculate the mean resistance during the patient's tidal breathing.
Measured: Over one week
Expiratory resistance (R19exp)
Using the tremoflo C-100 at 19 Hz to calculate resistance during the patient's exhalation.
Measured: Over one week
Resistance at high expiratory flow (Reo1)
Using the REOM device the resistance (Reo1) at high expiratory flow will be calculated.
Measured: Over one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study startJun 2021 (estimated)
- Primary completionMay 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thorasys Thoracic Medical Systems Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MedTeq
- Responsible party
- Sponsor
- Investigators
- Francine M Ducharme, MD, Principal investigator, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04903145
- Sponsor's protocol ID
- REOM 2019-2053
- Status last verified
- May 2021
- First submitted
- 19 May 2021
- Last updated
- 27 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kaminsky DA. What does airway resistance tell us about lung function? Respir Care. 2012 Jan;57(1):85-96; discussion 96-9. doi: 10.4187/respcare.01411.
PubMed 22222128Lamontagne AJ, Pelaez S, Grad R, Blais L, Lavoie KL, Bacon SL, Guay H, Gauthier A, McKinney ML, Ernst P, Collin J, Ducharme FM. Facilitators and solutions for practicing optimal guided asthma self-management: the physician perspective. Can Respir J. 2013 Jul-Aug;20(4):285-93. doi: 10.1155/2013/146839.
PubMed 23936888Kaplan A, Stanbrook M. Must family physicians use spirometry in managing asthma patients?: YES. Can Fam Physician. 2010 Feb;56(2):126, 128, 130,132; discussion e49, e51. No abstract available.
PubMed 20154239Lundblad LKA, Blouin N, Grudin O, Grudina L, Drapeau G, Restrepo N, Ducharme FM. Comparing lung oscillometry with a novel, portable flow interrupter device to measure lung mechanics. J Appl Physiol (1985). 2021 Apr 1;130(4):933-940. doi: 10.1152/japplphysiol.01072.2020. Epub 2021 Feb 4.
PubMed 33539262Lougheed MD, Lemiere C, Ducharme FM, Licskai C, Dell SD, Rowe BH, Fitzgerald M, Leigh R, Watson W, Boulet LP; Canadian Thoracic Society Asthma Clinical Assembly. Canadian Thoracic Society 2012 guideline update: diagnosis and management of asthma in preschoolers, children and adults. Can Respir J. 2012 Mar-Apr;19(2):127-64. doi: 10.1155/2012/635624.
PubMed 22536582Bates JH, Irvin CG, Farre R, Hantos Z. Oscillation mechanics of the respiratory system. Compr Physiol. 2011 Jul;1(3):1233-72. doi: 10.1002/cphy.c100058.
PubMed 23733641Goldman MD, Saadeh C, Ross D. Clinical applications of forced oscillation to assess peripheral airway function. Respir Physiol Neurobiol. 2005 Aug 25;148(1-2):179-94. doi: 10.1016/j.resp.2005.05.026.
PubMed 15990365MEAD J, WHITTENBERGER JL. Evaluation of airway interruption technique as a method for measuring pulmonary airflow resistance. J Appl Physiol. 1954 Jan;6(7):408-16. doi: 10.1152/jappl.1954.6.7.408. No abstract available.
PubMed 13117773Ducharme FM, Jroundi I, Jean G, Lavoie Boutin G, Lawson C, Vinet B. Interdevice agreement in respiratory resistance values by oscillometry in asthmatic children. ERJ Open Res. 2019 Mar 18;5(1):00138-2018. doi: 10.1183/23120541.00138-2018. eCollection 2019 Feb.
PubMed 30895187Oostveen E, MacLeod D, Lorino H, Farre R, Hantos Z, Desager K, Marchal F; ERS Task Force on Respiratory Impedance Measurements. The forced oscillation technique in clinical practice: methodology, recommendations and future developments. Eur Respir J. 2003 Dec;22(6):1026-41. doi: 10.1183/09031936.03.00089403.
PubMed 14680096Jones SR, Carley S, Harrison M. An introduction to power and sample size estimation. Emerg Med J. 2003 Sep;20(5):453-8. doi: 10.1136/emj.20.5.453.
PubMed 12954688Shi Y, Aledia AS, Tatavoosian AV, Vijayalakshmi S, Galant SP, George SC. Relating small airways to asthma control by using impulse oscillometry in children. J Allergy Clin Immunol. 2012 Mar;129(3):671-8. doi: 10.1016/j.jaci.2011.11.002. Epub 2011 Dec 17.
PubMed 22178635Robinson PD, Brown NJ, Turner M, Van Asperen P, Selvadurai H, King GG. Increased day-to-day variability of forced oscillatory resistance in poorly controlled or persistent pediatric asthma. Chest. 2014 Oct;146(4):974-981. doi: 10.1378/chest.14-0288.
PubMed 24991854Wong A, Hardaker K, Field P, Huvanandana J, King GG, Reddel H, Selvadurai H, Thamrin C, Robinson PD. Home-based Forced Oscillation Technique Day-to-Day Variability in Pediatric Asthma. Am J Respir Crit Care Med. 2019 May 1;199(9):1156-1160. doi: 10.1164/rccm.201809-1659LE. No abstract available.
PubMed 30822109Guyatt GH, Kirshner B, Jaeschke R. Measuring health status: what are the necessary measurement properties? J Clin Epidemiol. 1992 Dec;45(12):1341-5. doi: 10.1016/0895-4356(92)90194-r.
PubMed 1460470
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof-of-concept of the Measurement of Lung Function Using the Relaxed Expiratory Occlusion Monitor (REOM)
- ClinicalTrials.gov ID
- NCT04903145
- Acronym / sponsor ID
- REOM 2019-2053
- Conditions
- Asthma in Children
- Keywords
- tremoflo, oscillometry, interrupter, asthma, REOM
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Thorasys Thoracic Medical Systems Inc.Industry (pharma, biotech, devices)
- Collaborators
- MedTeq
- Study start
- Jun 2021 (estimated)
- Primary completion
- May 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 26 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
(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.
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:
- Children will receive by courier one new REOM unit, a tablet with charger, and related disposables (nose clips etc.),
- At a videoconference planned at a mutually conveniently time with the child and their parents the following will be obtained;
- Basic demographics (date of birth, age, sex, ethnicity, height, weight) and asthma morbidity and medications.
- 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.
- 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.
- Once the technique is mastered, the child will be asked to:
- Perform the REOM measurements once daily before receiving their asthma controller medication, ideally at the same time in the evening.
- 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.
- 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.
- 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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (7 listed)
- Children aged between 6 and 17 years old
- Adequate understanding of French or English
- Asthma diagnosis confirmed by a physician
- Poor asthma control in the past 6 months, that is,
Key exclusion criteria (3 listed)
- Inability to produce a good seal around the mouthpiece when previously tested with spirometry
- Oscillometry or REOM, contra-indication to performing respiratory tests (e.g., facial trauma, chest pain, severe scoliosis)
- Other reason interfering with respiratory testing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REOMTo compare data generated by the REOM device with data from the tremoflo C-100 device | Diagnostic test | – |
Primary outcome
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.
Expiratory resistance (R5exp)
Time frame: Over one week
Using the tremoflo C-100 at 5 Hz to calculate resistance during the patient's exhalation.
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.
3 secondary outcomes
Respiratory resistance R19
Time frame: Over one week
Expiratory resistance (R19exp)
Time frame: Over one week
Resistance at high expiratory flow (Reo1)
Time frame: Over one week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2021.
- Background: PubMed 22222128Kaminsky DA. What does airway resistance tell us about lung function? Respir Care. 2012 Jan;57(1):85-96; discussion 96-9. doi: 10.4187/respcare.01411.
- Background: PubMed 23936888Lamontagne AJ, Pelaez S, Grad R, Blais L, Lavoie KL, Bacon SL, Guay H, Gauthier A, McKinney ML, Ernst P, Collin J, Ducharme FM. Facilitators and solutions for practicing optimal guided asthma self-management: the physician perspective. Can Respir J. 2013 Jul-Aug;20(4):285-93. doi: 10.1155/2013/146839.
- Background: PubMed 20154239Kaplan A, Stanbrook M. Must family physicians use spirometry in managing asthma patients?: YES. Can Fam Physician. 2010 Feb;56(2):126, 128, 130,132; discussion e49, e51. No abstract available.
- Background: PubMed 33539262Lundblad LKA, Blouin N, Grudin O, Grudina L, Drapeau G, Restrepo N, Ducharme FM. Comparing lung oscillometry with a novel, portable flow interrupter device to measure lung mechanics. J Appl Physiol (1985). 2021 Apr 1;130(4):933-940. doi: 10.1152/japplphysiol.01072.2020. Epub 2021 Feb 4.
- Background: PubMed 22536582Lougheed MD, Lemiere C, Ducharme FM, Licskai C, Dell SD, Rowe BH, Fitzgerald M, Leigh R, Watson W, Boulet LP; Canadian Thoracic Society Asthma Clinical Assembly. Canadian Thoracic Society 2012 guideline update: diagnosis and management of asthma in preschoolers, children and adults. Can Respir J. 2012 Mar-Apr;19(2):127-64. doi: 10.1155/2012/635624.
- Background: PubMed 23733641Bates JH, Irvin CG, Farre R, Hantos Z. Oscillation mechanics of the respiratory system. Compr Physiol. 2011 Jul;1(3):1233-72. doi: 10.1002/cphy.c100058.
- Background: PubMed 15990365Goldman MD, Saadeh C, Ross D. Clinical applications of forced oscillation to assess peripheral airway function. Respir Physiol Neurobiol. 2005 Aug 25;148(1-2):179-94. doi: 10.1016/j.resp.2005.05.026.
- Background: PubMed 13117773MEAD J, WHITTENBERGER JL. Evaluation of airway interruption technique as a method for measuring pulmonary airflow resistance. J Appl Physiol. 1954 Jan;6(7):408-16. doi: 10.1152/jappl.1954.6.7.408. No abstract available.
- Background: PubMed 30895187Ducharme FM, Jroundi I, Jean G, Lavoie Boutin G, Lawson C, Vinet B. Interdevice agreement in respiratory resistance values by oscillometry in asthmatic children. ERJ Open Res. 2019 Mar 18;5(1):00138-2018. doi: 10.1183/23120541.00138-2018. eCollection 2019 Feb.
- Background: PubMed 14680096Oostveen E, MacLeod D, Lorino H, Farre R, Hantos Z, Desager K, Marchal F; ERS Task Force on Respiratory Impedance Measurements. The forced oscillation technique in clinical practice: methodology, recommendations and future developments. Eur Respir J. 2003 Dec;22(6):1026-41. doi: 10.1183/09031936.03.00089403.
- Background: PubMed 12954688Jones SR, Carley S, Harrison M. An introduction to power and sample size estimation. Emerg Med J. 2003 Sep;20(5):453-8. doi: 10.1136/emj.20.5.453.
- Background: PubMed 22178635Shi Y, Aledia AS, Tatavoosian AV, Vijayalakshmi S, Galant SP, George SC. Relating small airways to asthma control by using impulse oscillometry in children. J Allergy Clin Immunol. 2012 Mar;129(3):671-8. doi: 10.1016/j.jaci.2011.11.002. Epub 2011 Dec 17.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francine M Ducharme, MD principal investigator
St. Justine's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma in Children, run by Thorasys Thoracic Medical Systems Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francine M Ducharme, MD (514 345 4931 ext. 4398, francine.m.ducharme@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory resistance R5 (time frame: Over one week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04903145, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2021.