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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calibre First Sequence | Experimental | 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). |
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| COSMED First Sequence | Experimental | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COSMED Quark CPET metabolic cart | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| VO₂ peak correlation, as measured by Pearson or Spearman correlation coefficient between Calibre and COSMED | 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 | 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 | 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 | 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David MacLeod, M.B.B.S. | Duke University | Principal Investigator |
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| Calibre Biometrics | Device | 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. |
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| VE/VCO₂ agreement, as measured by Bland-Altman bias and limits of agreement between Calibre and COSMED | 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 |