Maximal Effort-dependent Respiratory Flow Rates

Lung Function Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03197701
• Other study ID #: 143201525127
• Status: Recruiting
• Phase: N/A
• First received: June 22, 2017
• Last updated: July 13, 2017
• Start date: September 2015
• Est. completion date: September 2019

Study information

• Verified date: September 2016
• Source: Universitair Ziekenhuis Brussel
• Contact: Shane Hanon, MD
• Phone: +3224776841
• Email: shane.hanon[@]uzbrussel.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: September 2019
• Est. primary completion date: September 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Lung Function

Locations

Country	Name	City	State
Belgium	UZ Brussel	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Normal values for maximal inspiratory flow rates	Peak inspiratory flow rate (PIF)	3 years
Primary	Normal values for maximal inspiratory flow rates	Maximal flow rate when 50% of inspiratory vital capacity has been inhaled (FIF50)	3 years
Secondary	Reproducibility of maximal inspiratory flow rates	Coefficient of variation for peak inspiratory flow rate (PIF)	3 years