Standardized Testing of Adult NIRS Oximetry Sensors using a Modular Phantom and Closed-loop Controlled Saturation System

用于基于近红外光谱的脑血氧仪（测量脑氧水平的设备）的近红外光谱（NIR）系统代表了一种强大且日益常见的方法，用于临床检测可能对组织活力产生不利影响的去饱和事件（氧水平显著下降）。成人脑血氧仪标准化测试的改进方法将补充目前监管许可所需的临床测试。最佳的测试方法可以被纳入脑血氧仪的现行标准，并开发成医疗器械开发工具。一种用于有效、最小负担地评价成人脑血氧仪器械性能的新型工具的可用性有可能导致临床性能的改善，这将影响接受脑损伤具有显著风险的外科手术的患者。此外，拟议的研究将与教育，指导和推广活动无缝集成，以推进生物光子成像和监管科学领域的跨学科计划。该提案旨在开发和验证一系列用于成人近红外血氧饱和度的新型基于体模的测试方法。这项工作的组成部分将包括：1）开发3D打印的神经血管模块（NVM），该模块包含一个闭环血液循环系统，可以控制血氧的调节，以及复制成人头部浅层几何形状和光学特性的硅树脂层; 2）研究关键混杂因素的影响，包括脑外层的厚度（例如，头皮/颅骨、蛛网膜下腔）、表皮色素沉着水平和总血液浓度对两种临床脑血氧仪中饱和度测量准确性的影响; 3）进行蒙特卡罗模拟以阐明成人脑血氧测定期间光-组织相互作用，包括混杂因素的影响。该奖项反映了NSF的法定使命，并被认为是值得通过使用基金会的知识价值和更广泛的影响审查标准进行评估的支持。

Near-infrared spectroscopy (NIR) systems for NIRS-based cerebral oximeters (devices to measure brain oxygen level) represent a powerful and increasingly common approach for clinical detection of desaturation events (significant drops in oxygen level) with the potential to adversely impact tissue viability. Improved methods for standardized testing of adult cerebral oximeters will complement clinical testing currently required for regulatory clearance. Optimal test methods could be incorporated into current standards for cerebral oximeters and developed into a medical device development tool. The availability of a novel tool for effective, least-burdensome evaluation of adult cerebral oximeter device performance has the potential to lead to improvements in clinical performance that will impact patients undergoing surgical procedures where cerebral impairment is a significant risk. Furthermore, the proposed research will be seamlessly integrated with educational, mentoring, and outreach activities to advance the cross-disciplinary program in the field of Biophotonics Imaging and Regulatory Sciences.This proposal aims to develop and validate a series of novel phantom-based test methods for adult NIRS oximetry. The components of this work will include: 1) Developing 3D-printed neurovascular module (NVM) incorporating a closed loop blood circulation system that enables controlled modulation of blood oxygenation, and silicone-based layers that replicate the geometry and optical properties of superficial layers in the adult head; 2) Investigating the effect of key confounding factors, including the thickness of extracerebral layers (e.g., scalp/skull, subarachnoid space), epidermal pigmentation level, and total blood concentration, on saturation measurement accuracy in two clinical cerebral oximeters; 3) Performing Monte Carlo simulations to elucidate light-tissue interactions during adult cerebral oximetry, including the effect of confounding factors.----This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.