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Validation of a New System for Measuring Ventilation and CO₂ Production

Comparison of a New Gas Exchange Measurement System During Exercise With a Reference System

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07677241
Acronym
PAIRFS
Enrollment
20
Registered
2026-06-30
Start date
2026-07-06
Completion date
2026-07-28
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healhty

Keywords

exercise, ventilatory measurement

Brief summary

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.

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.

Interventions

DEVICEZoneX

The 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).

Sponsors

University Hospital, Grenoble
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Comparison of ventilatory flow (VE) and carbon dioxide output (VCO₂) measurements obtained using the two systems.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.

Countries

France

Contacts

PRINCIPAL_INVESTIGATORstephane DOUTRELEAU, MD, PhD

University Grenoble Alps

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 4, 2026