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

Asthma in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04903145
• Other study ID #: REOM 2019-2053
• Status: Not yet recruiting
• Start date: June 2021
• Est. completion date: October 2022

Study information

• Verified date: May 2021
• Source: Thorasys Thoracic Medical Systems Inc.
• Contact: Francine M Ducharme, MD
• Phone: 514 345 4931
• Email: francine.m.ducharme[@]umontreal.ca
• Is FDA regulated: No
• Study type: Observational

Clinical 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 responsiveness to change of this technique when used as home monitoring device in children with asthma.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: October 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Asthma in Children

Intervention

Diagnostic Test:
• REOM
To compare data generated by the REOM device with data from the tremoflo C-100 device

Locations

Country	Name	City	State
Canada	Sainte-Justine University Hospital Center	Montréal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Thorasys Thoracic Medical Systems Inc.	MEDTEQ

Country where clinical trial is conducted

Canada, 

References & Publications (15)

Bates JH, Irvin CG, Farré R, Hantos Z. Oscillation mechanics of the respiratory system. Compr Physiol. 2011 Jul;1(3):1233-72. doi: 10.1002/cphy.c100058. Review. — View Citation

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). pii: 00138-2018. doi: 10.1183/23120541.00138-2018. eCollection 2019 Feb. — View Citation

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. Review. — View Citation

Guyatt GH, Kirshner B, Jaeschke R. Measuring health status: what are the necessary measurement properties? J Clin Epidemiol. 1992 Dec;45(12):1341-5. — View Citation

Jones SR, Carley S, Harrison M. An introduction to power and sample size estimation. Emerg Med J. 2003 Sep;20(5):453-8. Review. Erratum in: Emerg Med J. 2004 Jan;21(1):126. — View Citation

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. Review. — View Citation

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. English, French. — View Citation

Lamontagne AJ, Pelàez 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. — View Citation

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. Erratum in: Can Respir J. 2013 May-Jun;20(3):185. — View Citation

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. — View Citation

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. — View Citation

Oostveen E, MacLeod D, Lorino H, Farré 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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory resistance R5	Using the tremoflo C-100 at 5 Hz to calculate the mean resistance during the patient's tidal breathing.	Over one week
Primary	Expiratory resistance (R5exp)	Using the tremoflo C-100 at 5 Hz to calculate resistance during the patient's exhalation.	Over one week
Primary	Resistance at low expiratory flow (Reo2)	Using the REOM device the resistance (Reo2) at low expiratory flow will be calculated.	Over one week
Secondary	Respiratory resistance R19	Using the tremoflo C-100 at 19 Hz to calculate the mean resistance during the patient's tidal breathing.	Over one week
Secondary	Expiratory resistance (R19exp)	Using the tremoflo C-100 at 19 Hz to calculate resistance during the patient's exhalation.	Over one week
Secondary	Resistance at high expiratory flow (Reo1)	Using the REOM device the resistance (Reo1) at high expiratory flow will be calculated.	Over one week