Proof-of-concept of the Measurement of Lung Function Using the Relaxed Expiratory Occlusion Monitor (REOM)
NCT ID: NCT04903145
Last Updated: 2021-05-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
45 participants
OBSERVATIONAL
2021-06-30
2022-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Measurement of FeNO in Young Children With the NIOX VERO
NCT02661984
Telemonitoring of Lung Function by Spirometry
NCT04447664
Airway Resistance Measurement in Children 3 to 6 Years of Age
NCT02563210
The Evaluation of a Noninvasive Respiratory Monitor in Pediatric Patients Undergoing General Anesthesia
NCT02336022
Remote Monitoring in Preschool Wheeze
NCT05447832
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
REOM
To compare data generated by the REOM device with data from the tremoflo C-100 device
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
6 Years
17 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
MedTeq
INDUSTRY
Thorasys Thoracic Medical Systems Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Francine M Ducharme, MD
Role: PRINCIPAL_INVESTIGATOR
St. Justine's Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sainte-Justine University Hospital Center
Montreal, Quebec, Canada
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Lamontagne 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.
Kaplan 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.
Lundblad 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.
Lougheed 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.
Bates 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.
Goldman 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.
MEAD 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.
Ducharme 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.
Oostveen 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.
Jones 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.
Shi 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.
Robinson 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.
Wong 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.
Guyatt 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
REOM 2019-2053
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.