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临床试验/NCT05693961
NCT05693961已完成不适用

An Invasive Controlled Desaturation Study to Determine the Accuracy of the CART-I Pulse Oximeter (Sky Labs Inc., Korea) in Healthy Adult Volunteers

Sky Labs1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2021年6月12日最近更新:
适应症

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

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

研究者

发起方
Sky Labs
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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