Maximal Effort-dependent Respiratory Flow Rates
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03197701|
Recruitment Status : Unknown
Verified September 2016 by Universitair Ziekenhuis Brussel.
Recruitment status was: Recruiting
First Posted : June 23, 2017
Last Update Posted : July 18, 2017
|Condition or disease|
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).
- 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.
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Maximal Effort-dependent Respiratory Flow Rates: Reproducibility and Reference Values|
|Study Start Date :||September 2015|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||September 2019|
- Normal values for maximal inspiratory flow rates [ Time Frame: 3 years ]Peak inspiratory flow rate (PIF)
- Normal values for maximal inspiratory flow rates [ Time Frame: 3 years ]Maximal flow rate when 50% of inspiratory vital capacity has been inhaled (FIF50)
- Reproducibility of maximal inspiratory flow rates [ Time Frame: 3 years ]Coefficient of variation for peak inspiratory flow rate (PIF)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03197701
|Contact: Shane Hanon, MDemail@example.com|
|Contact: Daniel Schuermans, RNfirstname.lastname@example.org|
|Brussels, Belgium, 1090|
|Contact: Daniel Schuermans, RN|
|Principal Investigator: Shane Hanon, MD|
|Principal Investigator:||Shane Hanon, MD||Universitair Ziekenhuis Brussel|