A validation method for near-infrared spectroscopy based tissue oximeters for cerebral and somatic tissue oxygen saturation measurements.
A validation method for near-infrared spectroscopy based tissue oximeters for cerebral and somatic tissue oxygen saturation measurements.
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DOI：
10.1007/s10877-017-0015-1
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发表时间：
2018-04
影响因子：
2.2
通讯作者：
Lin HM
中科院分区：
文献类型：
--
作者：
Benni PB;MacLeod D;Ikeda K;Lin HM
我们描述了基于近红外光谱的forer - sight ELITE®（CAS Medical Systems, Inc., Branford， CT， USA）组织血氧仪的验证方法，该血氧仪用于测量成人受试者的大脑和躯体组织血氧饱和度（StO2），已提交给美国食品和药物管理局（FDA），以获得临床使用许可。这种验证方法是从文献中近红外光谱验证的历史演变而来的，FDA推荐使用Deming回归和自举统计验证方法。为了脑部验证，将前额大脑StO2测量值与健康成人受试者在受控缺氧序列中颈内静脉和动脉血饱和度的加权参考（REF CXB）进行比较，传感器放置在前额。对于躯体验证，将躯体StO2测量值与加权的70:30参考值（REF CXS）进行比较，并遵循类似的方案，将传感器放置在侧腹、股四头肌和小腿肌肉上。经知情同意，25名受试者成功完成了大脑验证研究。脑StO2与REF CXB的偏差和精度（1 SD）为−0.14±3.07%。经知情同意，24名受试者成功完成了躯体验证研究。与REF CXS相比，躯体StO2测量值的偏差和精度为0.04±4.22%，与侧腹、股四头肌和小腿StO2测量值的平均值相比，能最好地代表全球全身StO2测量值。提出的近红外光谱验证方法可能提供一种可靠的方法来测试近红外光谱监测仪，并使其符合临床使用的要求。
We describe the validation methodology for the NIRS based FORE-SIGHT ELITE® (CAS Medical Systems, Inc., Branford, CT, USA) tissue oximeter for cerebral and somatic tissue oxygen saturation (StO2) measurements for adult subjects submitted to the United States Food and Drug Administration (FDA) to obtain clearance for clinical use. This validation methodology evolved from a history of NIRS validations in the literature and FDA recommended use of Deming regression and bootstrapping statistical validation methods. For cerebral validation, forehead cerebral StO2 measurements were compared to a weighted 70:30 reference (REF CXB) of co-oximeter internal jugular venous and arterial blood saturation of healthy adult subjects during a controlled hypoxia sequence, with a sensor placed on the forehead. For somatic validation, somatic StO2 measurements were compared to a weighted 70:30 reference (REF CXS) of co-oximetry central venous and arterial saturation values following a similar protocol, with sensors place on the flank, quadriceps muscle, and calf muscle. With informed consent, 25 subjects successfully completed the cerebral validation study. The bias and precision (1 SD) of cerebral StO2 compared to REF CXB was −0.14 ± 3.07%. With informed consent, 24 subjects successfully completed the somatic validation study. The bias and precision of somatic StO2 compared to REF CXS was 0.04 ± 4.22% from the average of flank, quadriceps, and calf StO2 measurements to best represent the global whole body REF CXS. The NIRS validation methods presented potentially provide a reliable means to test NIRS monitors and qualify them for clinical use.
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影响因子：
3.3
作者：
An, HY;Lin, WL
通讯作者：
Lin, WL
DOI：
10.1016/0197-2456(86)90046-2
发表时间：
1986-09-01
期刊：
CONTROLLED CLINICAL TRIALS
影响因子：
--
作者：
DERSIMONIAN, R;LAIRD, N
通讯作者：
LAIRD, N
影响因子：
5.7
作者：
Bickler, Philip E.;Feiner, John R.;Rollins, Mark D.
通讯作者：
Rollins, Mark D.
影响因子：
1.2
作者：
Faulkner, J. T.;Hartley, M.;Tang, A.
通讯作者：
Tang, A.
影响因子：
3
作者：
Esaki, K;Hamaoka, T;Mizuno, M
通讯作者：
Mizuno, M