Validation of a New System for Measuring Ventilation and CO₂ Production
ConditionHealhty
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Grenoble
About this trial
Gas exchange measurement systems are complex and require specialized facilities and expertise. As a result, access to these measurements remains limited, particularly in the field of sports performance. The aim of this validation study was to compare measurements obtained with a reference device and a new portable system.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Healthy people from sports team
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
ZoneX
DeviceThe ZoneX device was developed by PAIRFS. It is a system designed to measure changes in expired volume and fluctuations in the fractional concentration of carbon dioxide in exhaled air (FeCO₂) in healthy volunteers. These data are transmitted in real time via Bluetooth Low Energy (BLE) to dedicated PC software for acquisition and analysis. The device is CE-marked, demonstrating compliance with applicable European regulatory requirements (certificate of conformity provided in the appendix).
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Comparison of ventilatory flow (VE) and carbon dioxide output (VCO₂) measurements obtained using the two systems.
Equivalence of measurements within a 5% margin of error.
Time frame
During the 5-minute rest period and throughout the exercise test until exhaustion. 30 minutes total.Sponsors and contacts
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Source ClinicalTrials.gov
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