Reduction of Pigmentation Dependent Errors using Spectroscopic Pulse Oximetery

使用光谱脉搏血氧仪减少色素沉着相关误差

• 批准号: 10385103
• 负责人: Vikas Khurana
• 金额: $ 25.66万
• 依托单位: AIMLOXY LLC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10385103
• 关键词: Accident and Emergency department; African; Algorithms; Antibiotics; Artificial Intelligence; Bilirubin; Blood; Blood gas; Businesses; COVID-19; Car Phone; Cardiopulmonary; Clinical; Clinical Research; Clip; Collaborations; Computer software; Data; Data Analytics; Data Set; Development; Devices; Diagnosis; Diagnostics Research; Disease; Emergency Medicine; Ethnic group; Evolution; Feasibility Studies; Fingers; Foxes; Frequencies; Generations; Goals; Gold; Hypoxia; Individual; Infant; Intervention; Investigation; Laboratory Research; Lead; Light; Liquid substance; Machine Learning; Measurement; Measures; Methods; Minority; Modeling; Monitor; Morbidity - disease rate; Morphology; Multicenter Trials; Optics; Outcome; Oxygen; Oxygen saturation measurement; Patients; Pattern; Performance; Phase; Photoplethysmography; Physiologic pulse; Pigmentation physiologic function; Pigments; Pilot Projects; Plethysmography; Positioning Attribute; Pulmonary Heart Disease; Pulse Oximetry; Reporting; Resource-limited setting; Sampling; Schools; Security; Sepsis; Severity of illness; Signal Transduction; Skin; Spectrum Analysis; Study Subject; System; Techniques; Technology; Time; Tissues; Universities; University Hospitals; Validation; Vertebral column; Work; artificial intelligence algorithm; base; clinical decision-making; clinical diagnosis; design; ethnic minority; experience; health care disparity; heart rate variability; human subject; improved; machine learning algorithm; machine learning model; machine learning prediction; mortality; multi-ethnic; new technology; next generation; novel; optical sensor; phase 2 study; prevent; prototype; racial disparity; racial minority; rapid diagnosis; research clinical testing; screening; sensor; sensor technology; skin color; temporal measurement; tool

PROJECT SUMMARY/ ABSTRACT Pulse oximetry is a powerful clinical tool for clinical evaluation of patients with cardiopulmonary compromise, however, multiple clinical studies have indicated pulse oximetry suffers from overestimation errors in darkly pigmented individuals, which is a critical mistake in screening for a cardiopulmonary disease, including COVID- 19, and could contribute to reports of outcome disparities in ethnic minorities. Aimloxy, LLC has been developing proprietary hardware and firmware for High Frequency Pulse Sensing Technology (HF-PST), which represents a next-generation evolution of photoplethysmography (PPG) pulse sensing technologies, which have conventionally served as the backbone of pulse oximetry. The Optical Diagnostic Research Laboratory (ODRL) at Temple University is involved in the development of optical sensing technologies for low-resource settings and has developed mobile-phone based technologies that include strategies for reducing pigmentation dependent inaccuracy in transcutaneous sensing of bilirubin levels in African-origin infants. The ODRL, Aimloxy, along with collaborators from Temple University Hospital’s Department of Emergency Medicine and Fox School of Business’ Center for Data Analytics will team together to perform initial development and benchtop characterization of a next-generation high frequency spectroscopic pulse oximeter capable of reducing pigmentation dependent errors in PPG and oximetry signals, conduct an initial human subjects feasibility study on a multi-ethnic population, and incorporate refined machine learning algorithms to improve measurement accuracy in pigmented individuals. The successful completion of this phase I proposal will set the stage for a full-scale study in phase II to develop a commercial prototype and perform multicenter trials to characterize accuracy and compare performance against traditional techniques in darkly pigmented individuals, ultimately helping reduce healthcare disparities in racial minorities.

项目摘要/摘要 脉搏血氧饱和度是临床评估心肺功能受损患者的有力工具， 然而，多项临床研究表明，脉搏血氧仪在黑暗中存在高估误差。 色素沉着的个体，这是筛查包括COVID在内的心肺疾病的一个严重错误- 19，并可能有助于关于少数族裔结果差异的报告。Aimloxy，LLC一直在开发 高频脉冲传感技术(HF-PST)的专有硬件和固件，它代表 下一代光体积描记(PPG)脉搏传感技术的发展 传统上作为脉搏血氧仪的支柱。光学诊断研究实验室(ODRL) 在坦普尔大学参与了针对低资源环境的光学传感技术的开发 并开发了基于移动电话的技术，包括减少色素沉着的策略 非洲裔婴儿经皮测胆红素水平的相关性不准确。ODRL，Aimloxy， 与坦普尔大学医院急诊科和狐狸学校的合作者一起 Of Business‘Center for Data Analytics将联手执行初始开发和平台 可还原的新一代高频光谱脉搏血氧仪的特性 PPG和血氧仪信号中的色素依赖误差，进行初步的人类受试者可行性研究 基于多种族人口，并结合改进的机器学习算法来改进测量 色素沉着个体的准确性。这一第一阶段提案的成功完成将为 第二阶段的全面研究，以开发商业原型并执行多中心试验以表征 最终，在深色肤色的个体中，与传统技术的准确性和性能进行比较 帮助缩小少数族裔的医疗保健差距。