Supporting health equity with bias-free pulse oximetry

通过无偏差脉搏血氧测定法支持健康公平

• 批准号: 10571419
• 负责人: Mariana Gross Figueiro
• 金额: $ 79.47万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-09 至 2026-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10571419
• 关键词: Advocate; Affect; Air; Black race; Blood; Breathing; COVID-19 pandemic; COVID-19 patient; Calibration; Catheters; Clinical Research; Clinics and Hospitals; Collaborations; Communities; Data; Development; Devices; Diagnosis; Diagnostic; Emergency Department Physician; Fingers; Fostering; Foundations; Health care facility; Home; Hospital Supply; Hospitalization; Hospitals; Hypoxemia; Institutes; Institution; Latinx; Licensing; Light; Literature; Manufacturer Name; Marketing; Measurement; Measures; Medical; Melanins; Methodology; Minority Groups; Modeling; Monitor; Morbidity - disease rate; Native Americans; Oxygen; Oxygen saturation measurement; Patients; Persons; Photoplethysmography; Physicians; Physiologic pulse; Pilot Projects; Play; Policies; Population; Population Heterogeneity; Provider; Publishing; Pulse Oximetry; Radial; Reading; Research; Risk; Role; Skin; Skin Pigmentation; Source; Specific qualifier value; Systematic Bias; Technology; Testing; Therapeutic; Translating; Underrepresented Minority; Ventilator; absorption; base; clinical practice; cohort; cost; disadvantaged population; health equity; high risk; human subject; improved; member; mortality; operation; outreach; pandemic disease; preference; prototype; respiratory; sensor; social media; tool; transmission process

Project Summary Pulse oximeters are essential for physicians’ diagnosis and monitoring of respiratory anomalies in patients. During the COVID-19 pandemic, their importance has grown because pulse-oximeter measurements of hypoxemia have become the major indication for hospitalizing patients. Clinical studies have shown that commercially available pulse oximeter measurements (SpO2) systematically overestimate true arterial oxygen saturation measurements (SaO2) for persons with dark skin pigmentation at low concentrations of O2 in the blood. This bias results in respiratory compromised persons with dark skin not meeting criteria for hospitalization or initiation of ventilator support, thereby putting specific populations (Black, Latinx, and Native American) at disproportionately greater risk for higher mortality or morbidity than those with light skin. No published explanations exist for this well-documented observation and, indeed, the available literature often contrarily states that pulse oximeter measurements are not affected by skin pigmentation. Our theoretical analysis and pilot research, however, demonstrate that the bias is due to present-day devices’ use of red light-emitting diode light sources, whose broad spectral bandwidth interacts with the spectral absorption of melanin concentration in skin to systematically shift the devices’ calibration. This shift causes artificially high values of SpO2 at low blood concentrations of O2 for patients with dark skin. The 3 proposed aims will extend our efforts to date, providing a scientific foundation for eliminating this bias and to foster development and promotion of simple, inexpensive, and bias-free pulse oximeters. In Aim 1, we will: (a) determine if there are other spectrally-dependent constituents in the finger that change with each pulse; (b) determine how light-source bandwidth interacts with melanin, including whether there are other pulse-dependent changes in spectral transmission through the fingers, and how sensitive SpO2 measurements are to light source bandwidth; (c) specify the practical peak wavelength and spectral bandwidth needed for bias-free pulse oximetry; and (d) fabricate an optimized light source that provides bias-free pulse oximeter measurements for testing in Aim 2. In Aim 2, we will demonstrate that the finger probe developed in Aim 1d provides bias-free pulse oximeter measurements (SpO2) that do not overestimate true arterial oxygen saturation measurements (SaO2) for persons with dark skin pigmentation at low blood concentrations of O2. In Aim 3, which will not employ human subjects as in Aims 1 and 2, we will translate our findings (i.e., print, in-person, and social media) to physicians, hospitals, and health care facilities commonly serving underrepresented minority populations. As part of Aim 3, in collaboration with a Stakeholder Board convened by the Institute for Health Equity Research, we will target the medical and affected communities to mitigate the impact of current devices through educational outreach and introduce them to bias-free pulse oximeters once they are available. Finally, we will license the technology to major manufacturers of pulse oximeters, giving preference to those who supply hospitals and clinics serving disadvantaged populations.

项目摘要 脉搏氧合对于医师对患者呼吸异常的诊断和监测至关重要。 在Covid-19大流行期间，它们的重要性已增强，因为脉搏氧计测量值 低氧血症已成为住院患者的主要迹象。临床研究表明 市售的脉搏氧测量（SPO2）系统地高估了真正的动脉氧 对于血液中低浓度的黑色皮肤色素沉着的人的饱和度测量（SAO2）。 这种偏见会导致呼吸道损害患者，皮肤深色不符合住院或 开始通风支持，从而将特定人群（黑人，拉丁裔和美国原住民）放在 与皮肤轻的人相比，高死亡率或发病率更高的风险不成比例。没有出版 对于这个有据可查的观察，存在解释，实际上，现有文献通常是相反的 指出脉搏氧测量不受皮肤色素沉着的影响。我们的理论分析和 但是，试点研究表明，偏见是由于当前的设备使用红光发光二极管所致 光源，其宽光谱带宽与黑色素浓度的光谱折磨相互作用 皮肤系统地移动设备的校准。这种转变导致在低血时人为地spo2值 深色皮肤患者的O2浓度。提出的3个目标将把我们的努力延长到迄今为止 消除这种偏见并促进和促进简单，廉价， 和无偏见的脉搏氧合。在AIM 1中，我们将：（a）确定是否存在其他频谱构成 用每个脉冲改变的手指； （b）确定光源带宽如何与黑色素相互作用， 包括通过手指传播光谱传输的其他脉冲依赖性变化，以及 敏感的SPO2测量如何光源带宽； （c）指定实用的峰值波长和 无偏脉冲血氧仪所需的光谱带宽； （d）制造一个优化的光源，提供 在AIM 2中进行测试的无偏脉冲氧测量。在AIM 2中，我们将证明手指探针 在AIM 1D中开发的无偏脉冲氧测量值（SPO2）不会高估真实 低血液上深色皮肤色素沉着的人的动脉氧饱和度测量（SAO2） O2的浓度。在AIM 3中，不会像AIM 1和2中那样采用人类主题，我们将翻译我们的 通常向医生，医院和医疗机构的发现（即印刷，面对面和社交媒体） 服务代表性不足的少数民族人口。作为AIM 3的一部分，与利益相关者委员会合作 在卫生公平研究所召集的 通过教育宣传来减轻当前设备的影响，并将其介绍给无偏见的脉冲 血氧对数一旦可用。最后，我们将向主要制造商许可该技术 Oximeters，优先考虑那些提供医院和诊所的人，为处境不利的人群提供服务。