Status:
UNKNOWN
Proof-of-concept of the Measurement of Lung Function Using the Relaxed Expiratory Occlusion Monitor (REOM)
Lead Sponsor:
Thorasys Thoracic Medical Systems Inc.
Collaborating Sponsors:
MedTeq
Conditions:
Asthma in Children
Eligibility:
All Genders
6-17 years
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 oscill...
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. Child...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2022
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04903145
Start Date
June 1 2021
End Date
October 1 2022
Last Update
May 27 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sainte-Justine University Hospital Center
Montreal, Quebec, Canada, H3T 1C5