Southworth R, Sutton R, Mize S, Stammers A H, Fristoe L W, Cook D, Hostetler D, Richenbacher W E
Medical University of South Carolina, Charleston, USA.
J Extra Corpor Technol. 1998 Dec;30(4):166-70.
Two methodologies for obtaining accurate blood gas and electrolyte values during cardiopulmonary bypass (CPB) are traditional laboratory analyzers, which use an electrochemical technology, and continuous in-line monitoring systems, which use a fluorometric and/or spectrophotometric technology. The purpose of the present study was to evaluate the accuracy of a new continuous in-line monitor, the 3M CDI Blood Parameter Monitoring System 500, which provides continuous in-line measurements of pH, PCO2, PO2, potassium (K+), oxygen saturation, hematocrit, hemoglobin, and temperature, during partial or complete CPB. Study parameters included arterial pH, PCO2, PO2, and K+ values. Overall performance was analyzed by calculating the mean difference (expressed as the bias) between the CDI system 500 and the laboratory analyzer for each parameter. The accuracy of the arterial pH, PCO2, and K+ values provided by the CDI system 500 was then evaluated using target values established in the acceptable performance standards for laboratory analyzers from the Clinical Laboratory Improvement Act of 1988 (CLIA '88). The accuracy of the PO2 value provided by the CDI system 500 was evaluated using a target value of +/- 10% of the reference, or laboratory analyzer, value. A prospective multi-center trial was conducted following Institutional Review Board approval. A total of 75 cases was included in the analyses, with over 200 data points from 4 clinical locations. Results for pH, PCO2, and K+ were within the target values established by CLIA '88. pH bias was 0.00 +/- 0.02 pH units. PCO2 bias was -0.3 +/- 3.3 mm Hg. K+ bias was approximately +0.12 +/- 0.31 mmole/l. Results for PO2 were within 10% of the reference value. PO2 bias was 7.5 +/- 13.8 mm Hg. The results of this clinical trial show that the CDI System 500 continuous in-line monitoring system provides values that meet the accuracy standards for laboratory analyzers for arterial pH, PCO2, PO2, and K+.
在体外循环（CPB）期间获取准确血气和电解质值的两种方法，一种是使用电化学技术的传统实验室分析仪，另一种是使用荧光和/或分光光度技术的连续在线监测系统。本研究的目的是评估一种新型连续在线监测仪——3M CDI血液参数监测系统500的准确性，该监测仪可在部分或完全CPB期间连续在线测量pH值、二氧化碳分压（PCO2）、氧分压（PO2）、钾离子（K+）、血氧饱和度、血细胞比容、血红蛋白和温度。研究参数包括动脉血pH值、PCO2、PO2和K+值。通过计算CDI系统500与实验室分析仪在每个参数上的平均差异（以偏差表示）来分析总体性能。然后，使用1988年《临床实验室改进法案》（CLIA '88）中实验室分析仪可接受性能标准所确定的目标值，评估CDI系统500提供的动脉血pH值、PCO2和K+值的准确性。使用参考值（即实验室分析仪值）的±10%作为目标值，评估CDI系统500提供的PO2值的准确性。在获得机构审查委员会批准后进行了一项前瞻性多中心试验。分析共纳入75例病例，来自4个临床地点的200多个数据点。pH值、PCO2和K+的结果在CLIA '88确定的目标值范围内。pH偏差为0.00±0.02个pH单位。PCO2偏差为-0.3±3.3毫米汞柱。K+偏差约为+0.12±0.31毫摩尔/升。PO2的结果在参考值的10%以内。PO2偏差为7.5±13.8毫米汞柱。该临床试验结果表明，CDI系统500连续在线监测系统提供的值符合实验室分析仪在动脉血pH值、PCO2、PO2和K+方面的准确性标准。
