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Maximal Effort-dependent Respiratory Flow Rates

Maximal Effort-dependent Respiratory Flow Rates: Reproducibility and Reference Values

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03197701
Enrollment
300
Registered
2017-06-23
Start date
2015-09-30
Completion date
2019-09-30
Last updated
2017-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Function

Keywords

Lung function, Inspiratory flow rates

Brief 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.

Interventions

None listed

Sponsors

Universitair Ziekenhuis Brussel
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* healthy hospital workers or visitors

Exclusion criteria

* current smokers or ex-smokers with a history of \> 80 PY * Presence or history of serious illness or thorax deformity (questionnaire) * recent respiratory tract infection (1 week)

Design outcomes

Primary

MeasureTime frameDescription
Normal values for maximal inspiratory flow rates3 yearsPeak inspiratory flow rate (PIF)

Secondary

MeasureTime frameDescription
Reproducibility of maximal inspiratory flow rates3 yearsCoefficient of variation for peak inspiratory flow rate (PIF)

Countries

Belgium

Contacts

Primary ContactShane Hanon, MD
shane.hanon@uzbrussel.be+3224776841
Backup ContactDaniel Schuermans, RN
daniel.schuermans@uzbrussel.be

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026