Dynamic HyperinflationNCT02831465
Dynamic Hyperinflation During Maximal Voluntary Ventilation in Healthy Subjects
A study testing Healthy Subjects in people with Dynamic Hyperinflation, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Dynamic Hyperinflation
- What is being tested?
- Healthy Subjects
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2015to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects
Who cannot join
- History of asthma, obstructive syndrome on basic lung function
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
CHU St. Pierre
Brussels, Brussels Capital, 1000
Audrey Herpeux, +3225067323, audrey_herpeux@stpierre-bru.be
About this study
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.
Read the 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.
- Conditions
- Dynamic Hyperinflation
- Being tested
- Healthy Subjects
- Keywords
- Dynamic hyperinflation, Maximal Voluntary Ventilation, Inspiratory capacity, healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy SubjectsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| healthy subjects | Experimental | Subjects with normal lung function between 40 and 70 years old. Receives: Behavioral: Healthy Subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: day one
Secondary outcomes (8)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: day one
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2016 (estimated)
- Study startApr 2015
- Primary completionMay 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dynamic HyperinflationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Saint Pierre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent Ninane, MD, PhD, Principal investigator, University Hospital Center Saint Pierre chest service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02831465
- Sponsor's protocol ID
- B076201318918
- Status last verified
- Jul 2016
- First submitted
- 11 Jul 2016
- Last updated
- 2 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Hyperinflation During Maximal Voluntary Ventilation in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02831465
- Acronym / sponsor ID
- B076201318918
- Conditions
- Dynamic Hyperinflation
- Keywords
- Dynamic hyperinflation, Maximal Voluntary Ventilation, Inspiratory capacity, healthy subjects
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire Saint PierreUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- May 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 13 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthy subjects | Experimental | Behavioral: Healthy SubjectsSubjects with normal lung function between 40 and 70 years old. |
Who may qualify
- Ages
- 40 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy subjects
Key exclusion criteria (1 listed)
- History of asthma, obstructive syndrome on basic lung function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy SubjectsSubjects 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. | Behavioural | healthy subjects |
Primary outcome
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.
8 secondary outcomes
Correlation between the frequency which induces Dynamic Hyperinflation (DH) and Forced Expiratory Volume in one second
Time frame: day one
Correlation between the frequency which induces Dynamic Hyperinflation (DH) and Forced Vital Capacity
Time frame: day one
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
Correlation between the frequency which induces Dynamic Hyperinflation (DH) and age
Time frame: day one
Correlation between the frequency which induces Dynamic Hyperinflation (DH) and body mass index
Time frame: day one
Correlation between the frequency which induces Dynamic Hyperinflation (DH) and Inspiratory Capacity at rest
Time frame: day one
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
Comparison Maximal Voluntary Ventilation with Forced Expiratory Volume in one second multiplied by 35
Time frame: day one
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2017.
- Individual participant dataSharing planned: No
Related trials for Dynamic Hyperinflation
Not yet recruiting
Efficacy of Self-titration of Ventilation in Overlap Syndrome (chronic Obstructive Pulmonar Disease + Sleep Apnea Syndrome ) with Dynamic Hyperinflation. EDIN-IDIN.
Pulmonary Disease, Chronic Obstructive
Recruiting
Effect of Elastic Chest Compression on Functional Exercise Capacity and Respiratory Performance in Patients With COPD
COPD, Hyperinflation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent Ninane, MD, PhD principal investigator
University Hospital Center Saint Pierre chest service
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Subjects in people with Dynamic Hyperinflation, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Audrey Herpeux (003225067323, audrey_herpeux@stpierre-bru.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency which induces Dynamic Hyperinflation (time frame: day one). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2017.