Multi Parameter Vital Signs Monitoring by the Corsano CardioWatch 287-2 Validation Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- RMSE of Heart Rate
研究概览
简要总结
Today, continuous monitoring of vital signs remains a challenge since it generally requires the patient to be connected to multiple wired sensors, which restricts patient mobility in the intra-mural setting and complicates home monitoring in the extra-mural setting. Wearable devices on the wrist, although emerging, are often not clinically validated or limited to the monitoring of one or two vital signs.
This study aims to validate the Corsano CardioWatch 287-2 for the continuous monitoring of heart rate at ≤ 4 bpm root mean squared error (RMSE); interbeat intervals at ≤ 50 ms RMSE; breathing rate at ≤ 2 brpm RMSE; and peripheral oxygen saturation at ≤ 3 percentage point RMSE. Also, this study aims to validate the Corsano CardioWatch 287-2 for the measurement of non-invasive blood pressure according to ISO 81060-2:2018.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old;
- •undergoing invasive monitoring, like coronary angiography;
- •able to provide consent.
排除标准
- •who cannot wear the Corsano CardioWatch 287 due to reasons such as allergic reactions, wounds, amputations etc.;
- •unable or not willing to sign informed consent;
- •with significant mental or cognitive impairment;
- •who do not have a suitable entry site for the invasive arterial line
- •who do not comply to criteria established by ISO 81060-2:2018.
结局指标
主要结局
RMSE of Heart Rate
时间窗: 30 minutes
Root-mean-squared error between PPG measured and gold standard measured heart rate
RMSE of Respiratory Rate
时间窗: 30 minutes
Root-mean-squared error between PPG measured and gold standard measured respiratory rate
RMSE of Oxygen Saturation
时间窗: 30 minutes
Root-mean-squared error between PPG measured and gold standard measured oxygen saturation
RMSE of Blood Pressure
时间窗: 30 minutes
Root-mean-squared error between PPG measured and gold standard measured blood pressure (systolic blood pressure and diastolic blood pressure)
次要结局
未报告次要终点