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CompletedNCT07677241PAIRFSUpdated Aug 3, 2026

Validation of a New System for Measuring Ventilation and CO₂ Production

An observational study in Healhty, sponsored by University Hospital, Grenoble. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-03.

Sponsored by University Hospital, Grenoble · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
20
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Healhty

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Keywords

  • exercise
  • ventilatory measurement
03

In context

Motor Activity

2,418 studies on the registry are indexed under Motor Activity; 1,162 are open to participants now.

This study's enrollment of 20 is below the median of 100 across 291 observational studies indexed under Motor Activity.

Browse Motor Activity studies →

Lead sponsor

University Hospital, Grenoble is the lead sponsor of 815 studies on the registry; 205 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Healthy people from sports team

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

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.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
20 participants (actual)
Patient registry
No

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).

06

What researchers measure

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.

07

Study locations

1 site
  • CHUGA
    Grenoble, 38000, France
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07677241
Lead sponsor
University Hospital, Grenoble
Responsible party
Sponsor
First posted
Jun 30, 2026
Start date
Jul 6, 2026
Primary completion
Jul 28, 2026
Completion
Jul 28, 2026
Last update
Aug 3, 2026

Study contacts

stephane DOUTRELEAU, MD, PhD
principal investigator · University Grenoble Alps

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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