An Invasive Controlled Desaturation Study to Determine the Accuracy of the CART-I Pulse Oximeter (Sky Labs Inc., Korea) in Healthy Adult Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sky Labs
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Accuracy of SpO2
研究概览
简要总结
A pulse oximeter is used for continuous monitoring of peripheral oxygen saturation (SpO2) and plays an important role in the early detection of hypoxia, guiding the titration of supplemental oxygen, and reducing the need for blood gas analysis. Therefore, the SpO2 accuracy of a pulse oximeter should be validated for patient safety. The objective of this study is to evaluate whether the CART-I pulse oximeter with a ring-type wearable PPG sensor (Sky Labs Inc., Seoul, Korea) provides clinically reliable SpO2 readings over the range of 70-100% SaO2, during steady-state, non-motion conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults aged 20-50 years2
- •COHb < 3 %
- •MetHb < 2 %
- •ctHb > 10 g/dl
- •Non-smoker
- •An individual deemed fit by the investigators to be included in the clinical trial
排除标准
- •History of respiratory disease
- •History of cardiovascular disease
- •History of fainting
- •History of diabetes
- •Obesity (defined as BMI > 30 kg/m2)
- •Allen's test positive (poor collateral blood supply of hand)
- •An individual who is judged to be difficult for the collection of normal PPG signals because CART-I is loose when being worn on fingers other than the thumb and little finger
结局指标
主要结局
Accuracy of SpO2
时间窗: 1 day
Mean bias, standard deviation, standard error, maximum/minimum bias, precision are calcuated
次要结局
未报告次要终点
