Clinical Evaluation of a New In-Line Continuous Blood Gas Monitor

Abstract

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 clinicallocations. 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+.