Calibre vs. COSMED
12. maj 2026 opdateret af: Duke University
Correlation of Cardiopulmonary Exercise Testing (CPET) VO2 Max Parameters Between the Calibre Device and COSMED Metabolic Cart
This study evaluates agreement between the Calibre device and the COSMED Quark CPET system for measurement of cardiorespiratory fitness parameters during maximal exercise testing in adults aged 18-55 years.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
40
Fase
- Ikke anvendelig
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ja
Beskrivelse
Inclusion Criteria:
- Age 18-55
- Able to speak English
- Able to provide informed consent
Exclusion Criteria:
- Acute myocardial infarction
- Unstable angina
- Syncope
- Uncontrolled asthma
- Arterial desaturation at rest on room air <85%
- Severe untreated arterial hypertension at rest (>200 mm Hg systolic, >120 mm Hg diastolic)
- Significant pulmonary hypertension
- Active thrombosis of the lower extremity, unless treated for at least 2 weeks prior to participation.
- Within 2 weeks of acute symptomatic pulmonary embolus
- Considered inappropriate to participate by Principal Investigator
- Previously experienced a heart attack
- Pregnancy
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Calibre First Sequence
Participants undergo cardiopulmonary exercise testing using the investigational Calibre device during Visit 1, followed by testing with the COSMED Quark CPET reference system during Visit 2 (at least 2 days later).
|
Investigational wearable facemask device with integrated sensors for breath-by-breath measurement of respiratory gas exchange and ventilatory parameters during cardiopulmonary exercise testing, evaluated against the COSMED Quark CPET reference system.
|
|
Eksperimentel: COSMED First Sequence
Participants undergo cardiopulmonary exercise testing using the COSMED Quark CPET reference system during Visit 1, followed by testing with the investigational Calibre device during Visit 2 (at least 2 days later).
|
FDA-cleared cardiopulmonary exercise testing (CPET) metabolic cart used as the reference comparator for measurement of respiratory gas exchange and ventilatory parameters during ramp cycle ergometry.
Participants wear a facemask connected to the system for breath-by-breath measurement of oxygen consumption (VO2), carbon dioxide production (VCO2), minute ventilation (VE), anaerobic threshold, and ventilatory efficiency during maximal exercise testing.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
VO₂ peak correlation, as measured by Pearson or Spearman correlation coefficient between Calibre and COSMED
Tidsramme: During CPET testing across Visit 1 and Visit 2, up to 7 days.
|
VO₂ peak measured during CPET will be compared between devices using Pearson or Spearman correlation coefficient, depending on data distribution.
|
During CPET testing across Visit 1 and Visit 2, up to 7 days.
|
|
VO₂ peak agreement, as measured by Bland-Altman bias and limits of agreement between Calibre and COSMED
Tidsramme: During CPET testing across Visit 1 and Visit 2, up to 7 days.
|
VO₂ peak measured during CPET will be compared between devices using Bland-Altman analysis to estimate average bias and limits of agreement.
|
During CPET testing across Visit 1 and Visit 2, up to 7 days.
|
|
Anaerobic threshold correlation, as measured by Pearson or Spearman correlation coefficient between Calibre and COSMED
Tidsramme: During CPET testing across Visit 1 and Visit 2, up to 7 days
|
Anaerobic threshold measured during CPET will be compared between devices using Pearson or Spearman correlation coefficient, depending on data distribution.
|
During CPET testing across Visit 1 and Visit 2, up to 7 days
|
|
Anaerobic threshold agreement, as measured by Bland-Altman bias and limits of agreement between Calibre and COSMED
Tidsramme: During CPET testing across Visit 1 and Visit 2, up to 7 days
|
Anaerobic threshold measured during CPET will be compared between devices using Bland-Altman analysis to estimate average bias and limits of agreement.
|
During CPET testing across Visit 1 and Visit 2, up to 7 days
|
|
VE/VCO₂ correlation, as measured by Pearson or Spearman correlation coefficient between Calibre and COSMED
Tidsramme: During CPET testing across Visit 1 and Visit 2, up to 7 days
|
Ventilatory equivalent for carbon dioxide (VE/VCO₂) measured during CPET will be compared between devices using Pearson or Spearman correlation coefficient, depending on data distribution.
|
During CPET testing across Visit 1 and Visit 2, up to 7 days
|
|
VE/VCO₂ agreement, as measured by Bland-Altman bias and limits of agreement between Calibre and COSMED
Tidsramme: During CPET testing across Visit 1 and Visit 2, up to 7 days
|
Ventilatory equivalent for carbon dioxide (VE/VCO₂) measured during CPET will be compared between devices using Bland-Altman analysis to estimate average bias and limits of agreement.
|
During CPET testing across Visit 1 and Visit 2, up to 7 days
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: David MacLeod, M.B.B.S., Duke University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. maj 2026
Primær færdiggørelse (Anslået)
1. maj 2027
Studieafslutning (Anslået)
1. juli 2027
Datoer for studieregistrering
Først indsendt
5. maj 2026
Først indsendt, der opfyldte QC-kriterier
12. maj 2026
Først opslået (Faktiske)
19. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
19. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- Pro00118791
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
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Ja
produkt fremstillet i og eksporteret fra U.S.A.
Ja
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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