Menu
Not yet recruiting NCT07596108

Calibre vs. COSMED

No phase Interventional Cardiorespiratory Fitness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: COSMED Quark CPET metabolic cart, Calibre Biometrics.
Who it may be relevant to
Registry conditions: Cardiorespiratory Fitness. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Correlation of Cardiopulmonary Exercise Testing (CPET) VO2 Max Parameters Between the Calibre Device and COSMED Metabolic Cart

Overview

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.

Interventions

  • Device COSMED Quark CPET metabolic cart
    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.
  • Device Calibre Biometrics
    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.

Primary outcome measures

  • VO₂ peak correlation, as measured by Pearson or Spearman correlation coefficient between Calibre and COSMED [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: During CPET testing across Visit 1 and Visit 2, up to 7 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07596108 · Pro00118791

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗