- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07677241
Validation of a New System for Measuring Ventilation and CO₂ Production (PAIRFS)
Comparison of a New Gas Exchange Measurement System During Exercise With a Reference System
Study Overview
Detailed Description
Exercise gas exchange measurement is the gold-standard method for assessing maximal and submaximal aerobic performance. The measured variables are essential for the objective evaluation of exercise performance.
These parameters are used to assess an individual's performance level, determine training zones, and thereby personalize training programs. Their accuracy is therefore of critical importance.
However, the assessment of ventilatory parameters is complex, as it relies on measurements of airflow (using pneumotachographs) and gas concentrations in inspired and expired air (using O₂- and CO₂-sensitive sensors). The physical properties and composition of air differ between inspiration and expiration. In particular, the saturation of expired air with water vapor-which does not behave as an ideal gas-introduces significant challenges and can reduce the reliability of current measurement systems.
The accumulation of these individual sources of measurement error ultimately determines the overall quality and accuracy of a commercial gas exchange analysis system.
Nevertheless, athletes and coaches require regular access to these measurements in order to prescribe appropriate training intensities and evaluate training effectiveness. A recent comparative study of several commercially available portable systems highlighted substantial variability in both measurement accuracy and overall performance among existing devices. Consequently, the availability of a simple, accessible, and, above all, more accurate measurement system would represent a significant advance for the sports performance community.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Stéphane L DOUTRELEAU, MD, PhD
- Phone Number: +33672511656
- Email: sdoutreleau@chu-grenoble.fr
Study Contact Backup
- Name: Marie COUDURIER, MD
- Phone Number: +33476765494
- Email: mcoudurier3@chu-grenoble.fr
Study Locations
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-
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Grenoble, France, 38000
- CHUGA
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Contact:
- Stéphane L DOUTRELEAU, MD, PhD
- Phone Number: +33672511656
- Email: sdoutreleau@chu-grenoble.fr
-
Contact:
- Marie COUDURIER, MD
- Phone Number: +33476765494
- Email: mcoudurier3@chu-grenoble.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Male or female adults (aged ≥ 18 years).
- Individuals affiliated with, or benefiting from, a health insurance or social security scheme.
- Individuals capable of understanding and signing an informed consent form.
- Individuals fluent in French.
Exclusion Criteria:
- Current tobacco smoking.
- Any cardiovascular, respiratory, or musculoskeletal condition that could impair the ability to perform a maximal exercise test.
- Individuals unwilling or unable to provide written informed consent.
- Individuals with hierarchical, family, or close personal relationships with the principal investigator.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparison of ventilatory flow (VE) and carbon dioxide output (VCO₂) measurements obtained using the two systems.
Time Frame: During the 5-minute rest period and throughout the exercise test until exhaustion. 30 minutes total.
|
Equivalence of measurements within a 5% margin of error.
|
During the 5-minute rest period and throughout the exercise test until exhaustion. 30 minutes total.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: stephane DOUTRELEAU, MD, PhD, University Grenoble Alps
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 38RC25.0261
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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