- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Stéphane L DOUTRELEAU, MD, PhD
- Telefonnummer: +33672511656
- E-mail: sdoutreleau@chu-grenoble.fr
Undersøgelse Kontakt Backup
- Navn: Marie COUDURIER, MD
- Telefonnummer: +33476765494
- E-mail: mcoudurier3@chu-grenoble.fr
Studiesteder
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Grenoble, Frankrig, 38000
- CHUGA
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Kontakt:
- Stéphane L DOUTRELEAU, MD, PhD
- Telefonnummer: +33672511656
- E-mail: sdoutreleau@chu-grenoble.fr
-
Kontakt:
- Marie COUDURIER, MD
- Telefonnummer: +33476765494
- E-mail: mcoudurier3@chu-grenoble.fr
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Comparison of ventilatory flow (VE) and carbon dioxide output (VCO₂) measurements obtained using the two systems.
Tidsramme: During the 5-minute rest period and throughout the exercise test until exhaustion. 30 minutes total.
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Equivalence of measurements within a 5% margin of error.
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During the 5-minute rest period and throughout the exercise test until exhaustion. 30 minutes total.
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: stephane DOUTRELEAU, MD, PhD, University Grenoble Alps
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 38RC25.0261
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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