Afshari Ali, Ghassemi Pejman, Lin Jonathan, Halprin Molly, Wang Jianting, Mendoza Gonzalo, Weininger Sandy, Pfefer T Joshua
Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993, USA.
Biomed Opt Express. 2019 Jul 2;10(8):3731-3746. doi: 10.1364/BOE.10.003731. eCollection 2019 Aug 1.
Cerebral oximetry based on near-infrared spectroscopy represents a unique noninvasive tool for real-time surgical monitoring, yet studies have shown a significant discrepancy in accuracy among commercial systems. Towards the establishment of a standardized method for performance testing, we have studied a solid phantom approach - based on a 3D-printed cerebrovascular module (CVM) incorporating an array of 148 cylindrical channels - that has several advantages over liquid phantoms. Development and characterization of a CVM prototype are described, including high-resolution imaging and spectrophotometry measurements. The CVM was filled with whole bovine blood tuned over an oxygen saturation range of 30-90% and molded-silicone layers simulating extracerebral tissues were used to evaluate penetration depth. Saturation measurement accuracy was assessed in two commercially-available clinical cerebral oximeters. For one oximeter, both neonatal and pediatric sensors showed a high degree of precision, whereas accuracy was strongly dependent on saturation level and extracerebral geometry. The second oximeter showed worse precision, yet greater robustness to variations in extracerebral layers. These results indicate that 3D-printed channel array phantoms represent a promising new approach for standardized testing of clinical oximeters.
基于近红外光谱的脑血氧饱和度测定法是一种用于实时手术监测的独特无创工具,但研究表明,各商业系统在准确性上存在显著差异。为建立一种性能测试的标准化方法,我们研究了一种基于实体模型的方法——该方法基于一个3D打印的脑血管模块(CVM),其包含148个圆柱形通道阵列——相较于液体模型,该方法具有若干优势。本文描述了CVM原型的开发与特性,包括高分辨率成像和分光光度测量。CVM中填充了在30%至90%氧饱和度范围内调节过的全牛血,并使用模拟脑外组织的模制硅胶层来评估穿透深度。在两款市售临床脑血氧仪中评估了饱和度测量准确性。对于其中一款血氧仪,新生儿和儿科传感器均显示出高度的精确性,而准确性则强烈依赖于饱和度水平和脑外几何形状。第二款血氧仪显示出较差的精确性,但对脑外层变化具有更强的稳健性。这些结果表明,3D打印通道阵列模型是临床血氧仪标准化测试的一种有前景的新方法。