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

NCT04903145 | Unknown

• 1 other identifier: REOM 2019-2053
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma in Children

Keywords

tremoflo; oscillometry; interrupter; asthma; REOM

Outcome Measures

Primary Outcomes (3)

• 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

• Expiratory resistance (R5exp)

  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)

  Using the REOM device the resistance (Reo2) at low expiratory flow will be calculated.

  Over one week

Secondary Outcomes (3)

• Respiratory resistance R19

  Over one week

• Expiratory resistance (R19exp)

  Over one week

• Resistance at high expiratory flow (Reo1)

  Over one week

Interventions

REOM DIAGNOSTIC_TEST

To compare data generated by the REOM device with data from the tremoflo C-100 device

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Thorasys Thoracic Medical Systems Inc.: lead
• MedTeq: collaborator

Study Sites (1)

Sainte-Justine University Hospital Center

Montreal, Quebec, H3T 1C5, Canada

Location

Related Publications (15)

• 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.

  PMID: 22222128 BACKGROUND

• 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.

  PMID: 23936888 BACKGROUND

• 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.

  PMID: 20154239 BACKGROUND

• 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.

  PMID: 33539262 BACKGROUND

• 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.

  PMID: 22536582 BACKGROUND

• 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.

  PMID: 23733641 BACKGROUND

• 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.

  PMID: 15990365 BACKGROUND

• 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.

  PMID: 13117773 BACKGROUND

• 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.

  PMID: 30895187 BACKGROUND

• 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.

  PMID: 14680096 BACKGROUND

• 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.

  PMID: 12954688 BACKGROUND

• 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.

  PMID: 22178635 BACKGROUND

• 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.

  PMID: 24991854 BACKGROUND

• 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.

  PMID: 30822109 BACKGROUND

• 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.

  PMID: 1460470 BACKGROUND

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Francine M Ducharme, MD

  St. Justine's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francine M Ducharme, MD

CONTACT

514 345 4931; francine.m.ducharme@umontreal.ca

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: May 26, 2021
• Study Start: June 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: October 1, 2022
• Last Updated: May 27, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)