NightOwl Pulse Oximeter Calibration Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- A_rms determination
研究概览
简要总结
Calibration of a software module that computes SpO2 based on photoplethysmography (PPG) traces acquired by a reflectance-based pulse oximeter which can be placed on the index finger or the forehead.
The study is designed in accordance with Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO 80601- 2-61:2011)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy subjects (ASA 1 and ASA 2) upon signing the informed consent. (ASA : american society of anesthesiologist's health score)
排除标准
- •smokers or individuals exposed to high levels of carbon monoxide that result in elevated carboxyhaemoglobin levels.
- •individuals subject to conditions that result in elevated levels of methaemoglobin.
- •individuals with arterial cannulation or hypoxia at FiO2 = 0,21
研究组 & 干预措施
Pulse oximeter calibration population
干预措施: NightOwl (Device)
结局指标
主要结局
A_rms determination
时间窗: Within 3 months after subject recruitment, the calibration and ARMS determination should have been performed.
After calibration of the NightOwl SpO2 software module, the A_rms metric will be computed. This metric constitutes the performance metric proposed by ISO 80601-2-61:2011 Annex CC: Determination of accuracy. This metric captures the bias and precision of the computed SpO2 values compared to the benchmark.
次要结局
未报告次要终点