Dynamic Hyperinflation During Maximal Voluntary Ventilation in Healthy Subjects

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 Overview

• Status: Unknown
• Conditions: Dynamic Hyperinflation
• Intervention / Treatment: Behavioral: Healthy Subjects

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.

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Audrey Herpeux; Phone Number: 003225067323; Email: audrey_herpeux@stpierre-bru.be
• Study Contact Backup: Name: Inge Muylle, MD; Phone Number: 003225354295; Email: inge_muylle@stpierre-bru.be

Study Locations

• Belgium
  • Brussels Capital Region
    • Brussels, Brussels Capital Region, Belgium, 1000
      • Recruiting
      • Chu St. Pierre
      • Contact: Audrey Herpeux; Phone Number: +3225067323; Email: audrey_herpeux@stpierre-bru.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 67 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy subjects

Exclusion Criteria:

• History of asthma, obstructive syndrome on basic lung function

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between the frequency which induces Dynamic Hyperinflation (DH) and Forced Expiratory Volume in one second	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	day one
Correlation between the frequency which induces Dynamic Hyperinflation (DH) and Forced Vital Capacity	We analyze if there is a good correlation between the frequency which induces a significant 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	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	day one
Correlation between the frequency which induces Dynamic Hyperinflation (DH) and age	We analyze if there is a good correlation between the frequency which induces a significant Dynamic Hyperinflation (DH) and age	day one
Correlation between the frequency which induces Dynamic Hyperinflation (DH) and body mass index	We analyze if there is a good correlation between the frequency which induces a significant Dynamic Hyperinflation (DH) and body mass index	day one
Correlation between the frequency which induces Dynamic Hyperinflation (DH) and Inspiratory Capacity at rest	We analyzed if there is a good correlation between the frequency which induces a significant Dynamic Hyperinflation (DH) and Inspiratory capacity at rest	day one
Correlation between the frequency which induces Dynamic Hyperinflation (DH) and IC/FVC ratio (IC : Inspiratory Capacity at rest ; FVC : Forced Vital Capacity)	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)	day one
Comparison Maximal Voluntary Ventilation with Forced Expiratory Volume in one second multiplied by 35	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	day one

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Saint Pierre
• Investigators: Principal Investigator: Vincent Ninane, MD, PhD, University Hospital Center Saint Pierre chest service

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Anticipated): May 1, 2017
• Study Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: July 11, 2016
• First Submitted That Met QC Criteria: July 12, 2016
• First Posted (Estimate): July 13, 2016

Study Record Updates

• Last Update Posted (Estimate): February 2, 2017
• Last Update Submitted That Met QC Criteria: February 1, 2017
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: healthy subjects; Inspiratory capacity; Dynamic hyperinflation; Maximal Voluntary Ventilation
• Other Study ID Numbers: B076201318918

Plan for Individual participant data (IPD)

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