Trials / Unknown
UnknownNCT03197701
Maximal Effort-dependent Respiratory Flow Rates
Maximal Effort-dependent Respiratory Flow Rates: Reproducibility and Reference Values
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 300 (estimated)
- Sponsor
- Universitair Ziekenhuis Brussel · Academic / Other
- Sex
- All
- Age
- 20 Years – 80 Years
- Healthy volunteers
- Accepted
Summary
The general objective of this project is to determine the best method to measure maximal inspiratory flow rates, to study their reproducibility and create reference equations in healthy subjects.
Detailed description
1. Reproducibility and reference values in normal subjects: the investigators will propose a method for measurement of the maximal inspiratory flow rates (MIFR) and establish their reproducibility in normal subjects. The variability of these inspiratory flow rates will be compared with the variability of effort dependent and non-effort dependent expiratory flow rates. Also, reference equations will be drawn up and compared to the only existing set of reference values (2) (needing a revision). 2. Reproducibility in disease: the investigators will evaluate the reproducibility of the MIFR in patients with neuromuscular diseases (Steinert muscular dystrophy, amyotrophic lateral sclerosis) and with upper airway obstruction (tracheal stenosis, thyroid enlargement) and compare to the reproducibility of expiratory flow rates in this population. 3. Monitoring of diseases: In the neuromuscular patients MIFR will be correlated to the existing parameters used for monitoring of these diseases (respiratory muscle strength, forced vital capacity), with a longitudinal follow-up. In the patients with upper airway obstruction the MIFR (quantitative measurement) will be compared to the visual inspection (qualitative interpretation) of the maximal flow-volume loop and also the evolution after a therapeutic intervention (airway stenting, thyroidectomy) will be monitored.
Conditions
Timeline
- Start date
- 2015-09-01
- Primary completion
- 2018-09-01
- Completion
- 2019-09-01
- First posted
- 2017-06-23
- Last updated
- 2017-07-18
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT03197701. Inclusion in this directory is not an endorsement.