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Trial record 2 of 82699 for:    subjects

Dynamic Hyperinflation During Maximal Voluntary Ventilation in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT02831465
Recruitment Status : Unknown
Verified July 2016 by Centre Hospitalier Universitaire Saint Pierre.
Recruitment status was:  Recruiting
First Posted : July 13, 2016
Last Update Posted : February 2, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Saint Pierre

Brief Summary:

Maximal Voluntary Ventilation (MVV) correlates well with maximal exercise capacity and is used to assess the ventilatory function during exercise in COPD (Chronic Obstructive Pulmonary Disease) patients. Dynamic hyperinflation (DH) often occurs during MVV in COPD and is believed to be due to expiratory flow limitation.

The present study is intended to assess whether DH can also occur during MVV in normal subjects without expiratory flow limitation.


Condition or disease Intervention/treatment Phase
Dynamic Hyperinflation Behavioral: Healthy Subjects Not Applicable

Detailed Description:

Maximal voluntary ventilation (MVV) correlates well with maximal exercise capacity and is used to assess the ventilatory function during exercise in COPD (Chronic Obstructive Pulmonary Disease) patients. Dynamic hyperinflation (DH) often occurs during MVV in COPD and is believed to be due to expiratory flow limitation. The present study is intended to assess whether DH can also occur during MVV in normal subjects without expiratory flow limitation.

Study design: healthy subjects with normal lung function will perform MVV at increasing breathing frequencies and maximal tidal volume, from 10 to 100 cycles per minute. Inspiratory capacity (IC) will be measured at rest and after each 12 seconds of MVV in order to detect DH. From the moment DH appeares at a given frequency, only one additional MVV at a higher breathing frequency will be conducted to confirm DH.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Dynamic Hyperinflation During Maximal Voluntary Ventilation in Healthy Subjects
Study Start Date : April 2015
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : June 2017

Arm Intervention/treatment
Experimental: healthy subjects
Subjects with normal lung function between 40 and 70 years old.
Behavioral: Healthy Subjects
Subjects with normal lung function performed MVV at increasing breathing frequencies and maximal tidal volume, from 10 to 100 cycles per minute. Inspiratory capacity (IC) was measured at rest and after each 12 seconds of MVV in order to detect DH. From the moment DH appeared at a given frequency, only one additional MVV at a higher breathing frequency was conducted to confirm DH.




Primary Outcome Measures :
  1. Frequency which induces Dynamic Hyperinflation [ Time Frame: day one ]
    We analyze Frequency of Maximal Voluntary Ventilation (MVV) which induces a significant decrease of the Inspiratory Capacity (IC) post MVV compared to the IC at rest.


Secondary Outcome Measures :
  1. Correlation between the frequency which induces Dynamic Hyperinflation (DH) and Forced Expiratory Volume in one second [ Time Frame: day one ]
    We analyze if there is a good correlation between the frequency which induces a significant Dynamic Hyperinflation (DH) and Forced Expiratory Volume in one second

  2. Correlation between the frequency which induces Dynamic Hyperinflation (DH) and Forced Vital Capacity [ Time Frame: day one ]
    We analyze if there is a good correlation between the frequency which induces a significant Dynamic Hyperinflation (DH) and Forced Vital Capacity

  3. Correlation between the frequency which induces Dynamic Hyperinflation (DH) and Forced Expiratory Flows at 25%, 50% and 75% of Forced Vital Capacity [ Time Frame: day one ]
    We analyze if there is a good correlation between the frequency which induces a significant Dynamic Hyperinflation (DH) and Forced Expiratory Flows at 25%, 50% and 75% of Forced Vital Capacity

  4. Correlation between the frequency which induces Dynamic Hyperinflation (DH) and age [ Time Frame: day one ]
    We analyze if there is a good correlation between the frequency which induces a significant Dynamic Hyperinflation (DH) and age

  5. Correlation between the frequency which induces Dynamic Hyperinflation (DH) and body mass index [ Time Frame: day one ]
    We analyze if there is a good correlation between the frequency which induces a significant Dynamic Hyperinflation (DH) and body mass index

  6. Correlation between the frequency which induces Dynamic Hyperinflation (DH) and Inspiratory Capacity at rest [ Time Frame: day one ]
    We analyzed if there is a good correlation between the frequency which induces a significant Dynamic Hyperinflation (DH) and Inspiratory capacity at rest

  7. Correlation between the frequency which induces Dynamic Hyperinflation (DH) and IC/FVC ratio (IC : Inspiratory Capacity at rest ; FVC : Forced Vital Capacity) [ Time Frame: day one ]
    We analyze if there is a good correlation between the frequency which induces a significant Dynamic Hyperinflation (DH) and IC/FVC ratio (IC : Inspiratory Capacity at rest ; FVC : Forced Vital Capacity)

  8. Comparison Maximal Voluntary Ventilation with Forced Expiratory Volume in one second multiplied by 35 [ Time Frame: day one ]
    We compare Maximal Voluntary Ventilation at the different frequencies with the common predictive value of maximal ventilation obtained by multiplying Forced Expiratory Volume in one second by 35



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Ages Eligible for Study:   40 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subjects

Exclusion Criteria:

  • History of asthma, obstructive syndrome on basic lung function

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): NCT02831465


Contacts
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Contact: Audrey Herpeux 003225067323 audrey_herpeux@stpierre-bru.be
Contact: Inge Muylle, MD 003225354295 inge_muylle@stpierre-bru.be

Locations
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Belgium
CHU St. Pierre Recruiting
Brussels, Brussels Capital Region, Belgium, 1000
Contact: Audrey Herpeux    +3225067323    audrey_herpeux@stpierre-bru.be   
Sponsors and Collaborators
Centre Hospitalier Universitaire Saint Pierre
Investigators
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Principal Investigator: Vincent Ninane, MD, PhD University Hospital Center Saint Pierre chest service

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Responsible Party: Centre Hospitalier Universitaire Saint Pierre
ClinicalTrials.gov Identifier: NCT02831465     History of Changes
Other Study ID Numbers: B076201318918
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: February 2, 2017
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Centre Hospitalier Universitaire Saint Pierre:
Dynamic hyperinflation
Maximal Voluntary Ventilation
Inspiratory capacity
healthy subjects