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Maximal Effort-dependent Respiratory Flow Rates

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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
Sponsor:
Information provided by (Responsible Party):
Universitair Ziekenhuis Brussel

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.

Condition or disease
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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Other
Time Perspective: Cross-Sectional
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



Primary Outcome Measures :
  1. Normal values for maximal inspiratory flow rates [ Time Frame: 3 years ]
    Peak inspiratory flow rate (PIF)

  2. 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 Outcome Measures :
  1. Reproducibility of maximal inspiratory flow rates [ Time Frame: 3 years ]
    Coefficient of variation for peak inspiratory flow rate (PIF)



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Normal healthy subjects
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)

Information from the National Library of Medicine

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


Contacts
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Contact: Shane Hanon, MD +3224776841 shane.hanon@uzbrussel.be
Contact: Daniel Schuermans, RN daniel.schuermans@uzbrussel.be

Locations
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Belgium
UZ Brussel Recruiting
Brussels, Belgium, 1090
Contact: Daniel Schuermans, RN         
Principal Investigator: Shane Hanon, MD         
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
Investigators
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Principal Investigator: Shane Hanon, MD Universitair Ziekenhuis Brussel
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Responsible Party: Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT03197701    
Other Study ID Numbers: 143201525127
First Posted: June 23, 2017    Key Record Dates
Last Update Posted: July 18, 2017
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Universitair Ziekenhuis Brussel:
Lung function
Inspiratory flow rates