Correlation of Cardiopulmonary Exercise Testing (CPET) VO2 Max Parameters Between the Calibre Device and COSMED Metabolic Cart
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- VO₂ peak correlation, as measured by Pearson or Spearman correlation coefficient between Calibre and COSMED
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-55
- •Able to speak English
- •Able to provide informed consent
排除标准
- •Acute myocardial infarction
- •Unstable angina
- •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
研究组 & 干预措施
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).
干预措施: COSMED Quark CPET metabolic cart (Device)
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).
干预措施: Calibre Biometrics (Device)
结局指标
主要结局
VO₂ peak correlation, as measured by Pearson or Spearman correlation coefficient between Calibre and COSMED
时间窗: 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.
VO₂ peak agreement, as measured by Bland-Altman bias and limits of agreement between Calibre and COSMED
时间窗: 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.
Anaerobic threshold correlation, as measured by Pearson or Spearman correlation coefficient between Calibre and COSMED
时间窗: 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.
Anaerobic threshold agreement, as measured by Bland-Altman bias and limits of agreement between Calibre and COSMED
时间窗: 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.
VE/VCO₂ correlation, as measured by Pearson or Spearman correlation coefficient between Calibre and COSMED
时间窗: 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.
VE/VCO₂ agreement, as measured by Bland-Altman bias and limits of agreement between Calibre and COSMED
时间窗: 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.
次要结局
未报告次要终点