Dynamic Hyperinflation During Maximal Voluntary Ventilation in Healthy Subjects
1 other identifier
interventional
45
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 11, 2016
CompletedFirst Posted
Study publicly available on registry
July 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedFebruary 2, 2017
July 1, 2016
2.1 years
July 11, 2016
February 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Frequency which induces Dynamic Hyperinflation
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.
day one
Secondary Outcomes (8)
Correlation between the frequency which induces Dynamic Hyperinflation (DH) and Forced Expiratory Volume in one second
day one
Correlation between the frequency which induces Dynamic Hyperinflation (DH) and Forced Vital Capacity
day one
Correlation between the frequency which induces Dynamic Hyperinflation (DH) and Forced Expiratory Flows at 25%, 50% and 75% of Forced Vital Capacity
day one
Correlation between the frequency which induces Dynamic Hyperinflation (DH) and age
day one
Correlation between the frequency which induces Dynamic Hyperinflation (DH) and body mass index
day one
- +3 more secondary outcomes
Study Arms (1)
healthy subjects
EXPERIMENTALSubjects with normal lung function between 40 and 70 years old.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Healthy subjects
You may not qualify if:
- History of asthma, obstructive syndrome on basic lung function
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU St. Pierre
Brussels, Brussels Capital, 1000, Belgium
Study Officials
- PRINCIPAL INVESTIGATOR
Vincent Ninane, MD, PhD
University Hospital Center Saint Pierre chest service
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 11, 2016
First Posted
July 13, 2016
Study Start
April 1, 2015
Primary Completion
May 1, 2017
Study Completion
June 1, 2017
Last Updated
February 2, 2017
Record last verified: 2016-07
Data Sharing
- IPD Sharing
- Will not share