Determination of SpO2 and PR Accuracy Specifications at Rest Accuracy of Pulse Oximeters With Profound Hypoxia Pulse Oximeter Accuracy Evaluation Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Nihon Kohden
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Accuracy of Sensor Oxygen Saturation by Arms Calculation
研究概览
简要总结
The aim of this study is to determine the accuracy of devices called pulse oximeters, which measure blood oxygen by shining light through fingers, ears or other skin, without requiring blood sampling. Study will be used with patients at rest.
详细描述
This study is intended to evaluate performance of a new design pulse oximeter (test device) manufactured by Nihon Kohden Corporation sufficiently to support performance claims for an FDA 510K submission or ISO technical file. Specifically, SpO2 and pulse rate accuracy will be assessed for a Nihon Kohden OLV-4202 pulse oximeter with adult patients under a controlled setting of varying levels of inhaled oxygen concentration levels for patients at rest.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Both male and female subjects who can give written informed consent
- •Healthy subjects capable of undergoing controlled hypoxemia to the levels outlined in the desaturation profile
- •Meeting the demographic requirements
排除标准
- •Age below 18 or over 50
- •Pregnant women
- •Significant arrhythmia
- •Blood pressure above 150 systolic or 90 diastolic
- •Carboxyhemoglobin levels over 3%
- •Subjects whom the investigator consider ineligible for the study
结局指标
主要结局
Accuracy of Sensor Oxygen Saturation by Arms Calculation
时间窗: 30 seconds
Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter (SpO2i) to that obtained from a blood sample (SRi) and calculating the arithmetic root mean square (Arms) error value as follows: Arms =Square root (sum of n samples of ((SpO2i - SRi) squared) / n)
次要结局
- Accuracy of Sensor Pulse Rate by Arms Calculation(30 seconds)