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

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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.