Accuracy and Precision of Peripheral Capillary Oxygen Saturation of Reprocessed Pulse Oximetry Sensors Compared to Oxygen Saturation in Arterial Blood Samples Assessed by CO-oximetry in Neonates
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 4
- 主要终点
- Bland-Altman Analysis for Nellcor Pulse Oximeter
研究概览
简要总结
To validate the SpO2 accuracy, bias, and precision of Medline's reprocessed pulse oximetry sensors as compared to SaO2 in arterial blood samples as assessed by CO-oximetry in neonates.
详细描述
Pulse oximetry helps in measuring peripheral capillary oxygen saturation (SpO2) continuously and non-invasively, and provides an indirect measurement of arterial oxygenation (SaO2) based on the red and infrared light-absorption characteristics of oxygenated and deoxygenated hemoglobin. Uses of pulse oximetry include detection of hypoxia, avoidance of hyperoxia, titration of fractional inspired oxygen, and enabling weaning from mechanical ventilation. Arterial blood gas (ABG) analysis, such as by the use of CO-oximeter, provides a direct measurement of SaO2. However, ABG analysis requires time, expense, and arterial access. Therefore, this study aims to validate the SpO2 accuracy of pulse oximetry sensors (manufactured by Nellcor and Masimo, and reprocessed by Medline Industries, LP) in neonates as compared to ABG measurements as part of their clinical standard of care (SOC), as assessed by CO-oximetry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who are postnatal 28 days or younger (neonates)
- •Subjects who are likely to receive one or more ABG measurements as part of their clinical SOC
- •Subjects who weigh less than 5 Kg (weight range for thesensors)
排除标准
- •Subjects with current signs and symptoms of a clinically significant Patent Ductus Arteriosus (PDA) combined with a current or planned arterial line placement which will affect the validity of the co-oximetry measurement
- •Subjects with physical malformation of hands, fingers, feet, or toes that would limit the ability to place sensors for this study
- •Subjects judged by the Principal Investigator (PI) to be inappropriate for participation in this study
- •Subjects for whom placing a pulse oximeter will cause dermatological issues (e.g. allergic to foam rubber or adhesive tape)
结局指标
主要结局
Bland-Altman Analysis for Nellcor Pulse Oximeter
时间窗: 15 episodic minutes
BIAS Measurement and 95% confidence interval calculated using a Bland-Altman plot (mean vs. difference of SaO2 and SpO2) and an error plot (SaO2 vs. difference of SaO2 and SpO2) were generated. The B\&A plot analysis is a simple way to evaluate a bias between the mean differences, and to estimate an agreement interval, within which 95% of the differences of the second method, compared to the first one, fall. Data can be analyzed both as unit differences plot and as percentage differences plot. We ran a percentage mean difference plot.
次要结局
未报告次要终点