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

使用模块化体模和闭环控制饱和系统对成人 NIRS 血氧传感器进行标准化测试

• 批准号: 2019254
• 负责人: Yu Chen
• 金额: $ 13.81万
• 依托单位: University of Massachusetts Amherst
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-01-01 至 2021-12-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2019254&HistoricalAwards=false
• 关键词: Standardized; Testing; Adult; NIRS; Oximetry

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.

用于基于 NIRS 的脑血氧计（测量脑氧水平的设备）的近红外光谱 (NIR) 系统代表了临床检测可能对组织活力产生不利影响的去饱和事件（氧水平显着下降）的强大且日益常见的方法。成人脑血氧计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。最佳测试方法可以纳入脑血氧计的现行标准，并开发成医疗设备开发工具。一种对成人脑血氧计设备性能进行有效、最轻松评估的新工具的出现，有可能改善临床表现，这将影响接受脑损伤风险重大的外科手术的患者。此外，拟议的研究将与教育、指导和外展活动无缝结合，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新颖的基于模型的测试方法用于成人 NIRS 血氧测定。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，能够控制调节血液氧合，以及复制表面层的几何形状和光学特性的硅基层。成人头部； 2）研究关键混杂因素，包括脑外层厚度（例如头皮/颅骨、蛛网膜下腔）、表皮色素沉着水平和总血浓度对两种临床脑血氧计饱和度测量精度的影响； 3) 进行蒙特卡罗模拟，以阐明成人脑血氧测定过程中光组织的相互作用，包括混杂因素的影响。----该奖项反映了 NSF 的法定使命，并通过使用基金会的智力优点和更广泛的评估，被认为值得支持影响审查标准。