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Clinical Trials/NCT03197701
NCT03197701
Unknown
Not Applicable

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

Universitair Ziekenhuis Brussel1 site in 1 country300 target enrollmentSeptember 2015
ConditionsLung Function

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lung Function
Sponsor
Universitair Ziekenhuis Brussel
Enrollment
300
Locations
1
Primary Endpoint
Normal values for maximal inspiratory flow rates
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2015
End Date
September 2019
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Normal values for maximal inspiratory flow rates

Time Frame: 3 years

Maximal flow rate when 50% of inspiratory vital capacity has been inhaled (FIF50)

Secondary Outcomes

  • Reproducibility of maximal inspiratory flow rates(3 years)

Study Sites (1)

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