Improved Accuracy of NIRS-based Skeletal Muscle Oxygen Saturation Measurement through Model Creation and Advanced Signal Processing Techniques

通过模型创建和先进的信号处理技术提高基于 NIRS 的骨骼肌氧饱和度测量的准确性

• 批准号: 8879942
• 负责人: Franz Ulrich
• 金额: $ 14.75万
• 依托单位: NONIN MEDICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-06-01 至 2015-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8879942
• 关键词: Blood; Blood Cells; Blood Transfusion; Blood Vessels; Brain; Brain Hypoxia-Ischemia; Cerebrum; Characteristics; Childhood; Clinical; Clinical Research; Collaborations; Consult; Detection; Development; Devices; Effectiveness; Financial compensation; Forearm; Hand; Health; Human; Infant; Lead; Leg; Legal patent; Length; Life; Light; Limb structure; Lipids; Lower Extremity; Measurement; Measures; Medical; Modeling; Monitor; Muscle; Near-Infrared Spectroscopy; Optics; Organ; Outcome; Oxygen saturation measurement; Patient Care; Patients; Peripheral arterial disease; Persons; Phase; Principal Investigator; Property; Reading; Reference Values; Research Infrastructure; Research Personnel; Shock; Site; Skeletal Muscle; Skin; Spottings; Surface; Techniques; Technology; Testing; Thigh structure; Tissue Model; Tissues; Transfusion; Validation; Variant; Vascular Diseases; Work; base; commercialization; design; experience; handheld mobile device; human tissue; improved; light scattering; neonate; pediatric patients; sensor; signal processing; tissue oxygenation; user-friendly; validation studies

DESCRIPTION (provided by applicant): Near infrared spectroscopy (NIRS) oximeters have the potential to measure tissue oxygenation in brain, muscle, and other organs to improve management of blood transfusion, shock, hypoxia-ischemia, and vascular disease. However, currently available NIRS tissue oximeters have either been calibrated primarily for cerebral oxygenation measurements or for other tissues at a limited depth, limiting accuracy or applicability to these clinical conditions. The aim of this proposal is to develop LED-based NIRS tissue oximetry sensors capable of measuring skeletal muscle oxygenation several centimeters deep to the surface. The sensor design will decrease inter-subject variability of the measurement and improve accuracy of the measurement. This depth of measurement will allow for application to monitor peripheral artery disease, shock detection, and blood cell transfusion. Key milestones include: • Determine optical light characteristics of skeletal muscle tissue which impact accuracy of NIRS tissue oximetry through a vascular occlusion study • Determine if an improved ex vivo blood-tissue model utilizing lipid mixing techniques can adequately represent blood tissue optical characteristics • Determine effectiveness of dynamic path-length adjustment signal processing to reduce inter-subject variability and improve skeletal muscle tissue oximetry accuracy Ex vivo models allow for known and controllable reference values, but fail to model the appropriate tissue scattering properties. Severed limb models have been tested, but also do not necessarily represent the scattering properties of living human tissue measured by NIRS. Human vascular occlusion models allow for appropriate light scattering properties to be assessed, but fail to have controlled or known reference saturations. A combined approach of an improved ex vivo model and a vascular occlusion study with advanced signal processing techniques will be incorporated, altering the ex vivo modeling to better represent optical characteristics of tissue. The end result will be a robust model of skeletal muscle tissue and a tissue oximetry sensor with improved accuracy for skeletal muscle measurement and reduced inter-subject variability. Phase II work will focus on expanding into lower limb occlusion studies and validation in peripheral arterial disease (PAD) patients to document characterization of the optical properties of skeletal muscle in the presence of plaque and possible light path adjustment techniques for correcting alterations in optics. Eventual commercialization includes a hand held portable device that will support spot check of muscle oxygenation in multiple clinical settings with possible extension to a wearable, mobile device.

描述（由申请人提供）：近红外光谱（NIRS）血氧仪具有测量脑、肌肉和其他器官组织氧合的潜力，以改善输血、休克、缺氧缺血和血管疾病的管理。然而，目前可用的近红外组织血氧仪要么主要用于脑氧合测量，要么用于有限深度的其他组织，限制了这些临床条件的准确性或适用性。该提案的目的是开发基于led的近红外组织血氧测量传感器，能够测量几厘米深的骨骼肌氧合。传感器的设计将减少测量的主体间变异性，提高测量的精度。这种测量深度将允许应用于外周动脉疾病监测、休克检测和血细胞输注。关键里程碑包括：