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NCT Number: NCT07677241

Validation of a New System for Measuring Ventilation and CO₂ Production

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ZoneX

Device

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).

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marie COUDURIER, MD

CONTACT

[email protected]

+33476765494

Stephane L DOUTRELEAU, MD, PhD

CONTACT

[email protected]

+33672511656

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

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

Acronym: PAIRFS

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 30, 2026
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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