Racial Disparities in Accuracy of Pulse Oximetry

脉搏血氧饱和度准确性的种族差异

• 批准号: 10451087
• 负责人: Heather M Siefkes
• 金额: $ 7.87万
• 依托单位: UNIVERSITY OF CALIFORNIA AT DAVIS
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-03-01 至 2024-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10451087
• 关键词: Accident and Emergency department; Accounting; Adult; Age; Bilirubin; Blood Transfusion; Blood capillaries; Blood gas; Caring; Clinical Trials; Collaborations; Data; Detection; Devices; Diagnosis; Disease; Dissociation; Equipment and Supplies; Erythrocyte Transfusion; Erythrocytes; Future; Gender; Gestational Age; Gold; Hemoglobin; Hemoglobin A; Hypoxemia; Hypoxemic Respiratory Failure; Incidence; Individual; Infant; Infrastructure; Lead; Life; Light; Lung diseases; Measurement; Measures; Medical; Melanins; Multicenter Studies; Necrotizing Enterocolitis; Neonatal; Neonatal Intensive Care Units; Newborn Infant; Outcome; Oxygen; Packed Red Blood Cell Transfusion; Partial Pressure; Patients; Peripheral; Physiologic pulse; Physiological; Premature Infant; Prospective cohort; Pulmonary Hypertension; Pulse Oximetry; Research; Resuscitation; Risk; Severities; Skin; Skin Pigmentation; Source; Testing; Transfusion; United States Food and Drug Administration; clinically significant; cohort; congenital heart disorder; critically ill newborn; disease diagnosis; experience; indexing; infant monitoring; innovation; member; mortality; multidisciplinary; neonatal pulmonary hypertension; neonate; oxygen toxicity; postnatal; racial difference; racial disparity; routine care; screening; sensor; sex; skin color; standard measure; supplemental oxygen; targeted treatment

PROJECT SUMMARY/ABSTRACT We propose to assess the correlation between arterial oxygen saturation (SaO2) and peripheral oxygen saturation measured by pulse oximetry (SpO2) discrepancy and skin pigmentation. Recent data demonstrated that pulse oximetry devices overestimate SpO2 in darker skin adults. This is less understood in newborns. However, medical conditions associated with hypoxemia occur more commonly in black infants and the conditions associated with hyperoxemia occur less frequently in black infants. Thus, raising the question if pulse oximeters overestimate SpO2 in black infants and falsely putting them in the “safe” zone. We will measure simultaneous SaO2 and SpO2 among varying degrees of skin pigmentation while accounting for other physiologic variables such as gestational age, receipt of red blood cells, bilirubin, and sex, to assess the impact of skin pigmentation on the SaO2-SpO2 discrepancy. Members of our team have experience with research related to oxygen targeted therapies and pulse oximetry in newborns. Additionally, our team members have experience working with recorded pulse oximetry data and have received support from the leading pulse oximeter device company to supply equipment and sensors for this proposal. The proposed research is significant because it will answer the question if pulse oximetry bias due to skin color occurs to a degree that is clinically significant and could cause harm for newborns with darker skin. Results from this study will inform a larger trial in which we will assess the effect of postnatal age on pulse oximetry accuracy and multiple oximeters and will impact how pulse oximetry is used for infants of varying skin color in routine care such CCHD screening, SpO2 targeted care and future clinical trials. Additionally, this is innovative because it will use readily available SpO2 and SaO2 measurements from infants with varying degrees of light and dark skin to assess pulse oximeter bias and imprecision and will use a noninvasive device to measure melanin index to quantify skin pigmentation. Additionally, it will take into consideration other physiologic impacts on SpO2 such as gestational age, degree of hypoxemia, gender, and red blood cell transfusion. Through collaboration between two neonatal intensive care units, we will establish the infrastructure and necessary multidisciplinary relationships that can later be expanded to conduct future multicenter studies to evaluate the potential disparity from pulse oximeters and how it correlates with skin pigmentation.

项目总结/摘要 我们建议评估动脉血氧饱和度（SaO 2）和外周氧之间的相关性 通过脉搏血氧饱和度（SpO 2）差异和皮肤色素沉着测量的饱和度。最近的数据显示， 脉搏血氧仪高估了深色皮肤成人的SpO 2。这在新生儿中较少被理解。 然而，与低氧血症相关的医学状况在黑人婴儿中更常见， 与高氧血症相关的病症在黑人婴儿中较少发生。因此，提出一个问题，如果 脉搏血氧仪高估了黑人婴儿的SpO 2，并错误地将他们置于“安全”区。我们将 在不同程度的皮肤色素沉着中同时测量SaO 2和SpO 2，同时考虑其他 生理变量，如胎龄，红细胞，胆红素和性别，以评估 皮肤色素沉着对SaO 2-SpO 2差异的影响。 我们的团队成员具有与氧靶向治疗和脉冲相关的研究经验 新生儿的血氧测定。此外，我们的团队成员具有记录脉搏血氧饱和度的工作经验 数据，并得到了领先的脉搏血氧仪设备公司的支持，提供设备， 传感器对此表示 拟议的研究是重要的，因为它将回答这个问题，如果脉搏血氧饱和度偏差，由于 皮肤颜色的出现达到临床上显著的程度，并且可能对皮肤较深的新生儿造成伤害。 这项研究的结果将为一项更大的试验提供信息，在该试验中，我们将评估出生后年龄对脉搏的影响。 血氧测定准确度和多个血氧仪，并将影响脉搏血氧测定法如何用于不同皮肤的婴儿 常规护理（如CCHD筛查、SpO 2靶向护理和未来临床试验）中的彩色。此外，这是 创新，因为它将使用随时可用的SpO 2和SaO 2测量值， 皮肤的浅色和深色程度，以评估脉搏血氧仪偏倚和不精确性，并将使用无创器械 来测量黑色素指数以量化皮肤色素沉着。此外，它还将考虑其他 对SpO 2的生理影响，如胎龄、低氧血症程度、性别和红细胞 输血通过两个新生儿重症监护室之间的合作，我们将建立 基础设施和必要的多学科关系，以后可以扩大，以进行未来的 多中心研究，以评价脉搏血氧仪的潜在差异及其与皮肤的相关性 色素沉着