Nizami Shermeen, Greenwood Kim, Barrowman Nick, Harrold JoAnn
Systems and Computer Engineering, Carleton University, 1125 Colonel By Drive, Ottawa, ON, K1S 5B6, Canada.
Clinical Engineering, The Children's Hospital of Eastern Ontario, Ottawa, Canada.
Cardiovasc Eng Technol. 2015 Sep;6(3):383-91. doi: 10.1007/s13239-015-0229-7. Epub 2015 Jun 9.
This crossover observational study compares the data characteristics and performance of new-generation Nellcor OXIMAX and Masimo SET SmartPod pulse oximeter technologies. The study was conducted independent of either original equipment manufacturer (OEM) across eleven preterm infants in a Neonatal Intensive Care Unit (NICU). The SmartPods were integrated with Dräger Infinity Delta monitors. The Delta monitor measured the heart rate (HR) using an independent electrocardiogram sensor, and the two SmartPods collected arterial oxygen saturation (SpO2) and pulse rate (PR). All patient data were non-Gaussian. Nellcor PR showed a higher correlation with the HR as compared to Masimo PR. The statistically significant difference found in their median values (1% for SpO2, 1 bpm for PR) was deemed clinically insignificant. SpO2 alarms generated by both SmartPods were observed and categorized for performance evaluation. Results for sensitivity, positive predictive value, accuracy and false alarm rates were Nellcor (80.3, 50, 44.5, 50%) and Masimo (72.2, 48.2, 40.6, 51.8%) respectively. These metrics were not statistically significantly different between the two pulse oximeters. Despite claims by OEMs, both pulse oximeters exhibited high false alarm rates, with no statistically or clinically significant difference in performance. These findings have a direct impact on alarm fatigue in the NICU. Performance evaluation studies can also impact medical device purchase decisions made by hospital administrators.
这项交叉观察性研究比较了新一代Nellcor OXIMAX和Masimo SET SmartPod脉搏血氧仪技术的数据特征和性能。该研究在一家新生儿重症监护病房（NICU）中，对11名早产儿独立于任何原始设备制造商（OEM）进行。SmartPods与德尔格Infinity Delta监护仪集成。Delta监护仪使用独立的心电图传感器测量心率（HR），两个SmartPods收集动脉血氧饱和度（SpO2）和脉搏率（PR）。所有患者数据均为非高斯分布。与Masimo PR相比，Nellcor PR与HR的相关性更高。它们中位数的统计学显著差异（SpO2为1%，PR为1次/分钟）被认为在临床上无显著意义。观察并分类了两个SmartPods产生的SpO2警报以进行性能评估。灵敏度、阳性预测值、准确性和误报率的结果分别为Nellcor（80.3、50、44.5、50%）和Masimo（72.2、48.2、40.6、51.8%）。这两种脉搏血氧仪之间的这些指标在统计学上没有显著差异。尽管OEM厂商有宣称，但两种脉搏血氧仪都表现出较高的误报率，在性能上没有统计学或临床上的显著差异。这些发现对NICU中的警报疲劳有直接影响。性能评估研究也会影响医院管理人员做出的医疗设备采购决策。
