Maximal Effort-dependent Respiratory Flow Rates

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

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.

Study Overview

• Status: Unknown
• Conditions: Lung Function

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.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1090
    • Recruiting
    • UZ Brussel
    • Contact: Daniel Schuermans, RN
    • Principal Investigator: Shane Hanon, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Normal healthy subjects

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Normal values for maximal inspiratory flow rates	Peak inspiratory flow rate (PIF)	3 years
Normal values for maximal inspiratory flow rates	Maximal flow rate when 50% of inspiratory vital capacity has been inhaled (FIF50)	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reproducibility of maximal inspiratory flow rates	Coefficient of variation for peak inspiratory flow rate (PIF)	3 years

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel
• Investigators: Principal Investigator: Shane Hanon, MD, Universitair Ziekenhuis Brussel

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Anticipated): September 1, 2018
• Study Completion (Anticipated): September 1, 2019

Study Registration Dates

• First Submitted: June 22, 2017
• First Submitted That Met QC Criteria: June 22, 2017
• First Posted (Actual): June 23, 2017

Study Record Updates

• Last Update Posted (Actual): July 18, 2017
• Last Update Submitted That Met QC Criteria: July 13, 2017
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Lung function; Inspiratory flow rates
• Other Study ID Numbers: 143201525127

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO