Early Warning system for detecting pre-eclampsia

检测先兆子痫的早期预警系统

• 批准号: 8455669
• 负责人: TAMMY Y EULIANO
• 金额: $ 14.94万
• 依托单位: CONVERGENT ENGINEERING, INC.
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-03-01 至 2014-05-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8455669
• 关键词: Accident and Emergency department; Admission activity; Algorithms; Amplifiers; Angiogenic Factor; Appearance; Area; Biological Markers; Blood Circulation; Blood Vessels; Cardiovascular system; Caring; Classification; Clinic; Clinical; Coagulation Process; Computer software; Data; Data Collection; Data Set; Databases; Decision Making; Detection; Development; Devices; Diagnosis; Diagnostic tests; Disease; Effectiveness; Electrocardiogram; Future; Goals; Grant; Health Personnel; Hospitalization; Human Resources; Hypertension; Institution; Institutional Review Boards; Lead; Left; Life; Linear Models; Literature; Logistic Regressions; Longitudinal Studies; Magnesium; Methods; Modeling; Monitor; Morbidity - disease rate; Neonatal Mortality; Outcome; Pathogenesis; Patient Recruitments; Patients; Performance; Phase; Photoplethysmography; Physiologic pulse; Pilot Projects; Pre-Eclampsia; Pregnancy; Premature Birth; Pulmonary Edema; Pulse Oximetry; Research; Resources; Risk; Seizures; Severities; Steroids; Symptoms; System; Tablets; Techniques; Technology; Testing; Therapeutic Intervention; Training; Validation; Woman; Work; base; cost; diagnostic accuracy; early onset; high risk; hypertension prevention; improved; infant death; laptop; miniaturize; mortality; neonatal morbidity; pregnancy disorder; prenatal; prevent; prototype; public health relevance; sensor; tertiary care; ward

DESCRIPTION (provided by applicant): Preeclampsia, a hypertensive disorder of pregnancy, is a leading cause of maternal and neonatal morbidity and mortality around the world, responsible for approximately 76,000 maternal and 500,000 infant deaths per year. As a heterogeneous and poorly understood disorder, its pathogenesis and possible treatments are an area of active research. While the majority of morbidity and mortality from the disorder can be prevented with close monitoring and treatment in a tertiary care center, atypical presentations with delayed diagnosis and inability to accurately predict which women will progress to a severe form complicates management. Additionally, many women are treated unnecessarily at untold cost in prolonged antepartum admissions, monitoring, and complications from misguided therapy. Technology to accurately diagnose preeclampsia, or better yet predict which women will develop the disease, would enhance treatment and save lives. Current research focuses on an array of biomarkers in the bloodstream; a viable, if expensive, opportunity for both prediction and improved diagnostic accuracy. The current proposal seeks a much less costly alternative. The vascular derangement that underlies preeclampsia develops months before the onset of symptoms. Early work shows these changes are detectable by analyzing features of the maternal cardiovascular system. The current project will develop and test an inexpensive, reusable, non-invasive device that accurately diagnoses preeclampsia. The device employs a single ECG lead and a pulse oximetry probe. Software algorithms extract more than 80 features from these two technologies. The phases of the project include 1) collect data on 100 preeclamptic and 100 control parturients in labor & delivery with known diagnosis, using a bench-top system; 2) refine preliminary algorithms with regression and nonlinear techniques; 3) develop a miniaturized prototype of the device and validate performance. For Phase II the device will be employed in two additional studies: (1) longitudinal data collection in prenatal clinic patients to refine algorithms for prediction of preeclampsia months before onset and (2) large-scale data collection in delivery wards for development of algorithms that distinguish mild preeclamptics from those who will go on to develop severe disease. The eventual goal is a small, inexpensive, reusable, non-invasive device for use in clinics, emergency departments and delivery wards to predict and diagnose preeclampsia and differentiate future mild and severe disease. The cost of the device allows for a per use cost of as little as five cents. It will support better decision making regarding patient management including level of monitoring, delivery planning and therapeutic interventions.

描述（由申请人提供）：先兆子痫是一种妊娠期高血压疾病，是全球孕产妇和新生儿发病率和死亡率的主要原因，每年造成约76，000例孕产妇和500，000例婴儿死亡。作为一种异质性和知之甚少的疾病，其发病机制和可能的治疗方法是一个活跃的研究领域。虽然大多数疾病的发病率和死亡率可以通过三级护理中心的密切监测和治疗来预防，但延迟诊断的非典型表现以及无法准确预测哪些女性将发展为严重形式使管理复杂化。此外，许多妇女在长期产前入院、监测和错误治疗引起的并发症中接受了不必要的治疗，费用难以计算。准确诊断先兆子痫的技术，或者更好地预测哪些妇女会患上这种疾病，将加强治疗并挽救生命。目前的研究集中在血流中的一系列生物标志物上;这是一个可行的，如果昂贵的话，预测和提高诊断准确性的机会。目前的提案寻求一种成本低得多的替代方案。血管紊乱是先兆子痫的基础，在症状出现前几个月就出现了。早期的研究表明，这些变化可以通过分析母体心血管系统的特征来检测。目前的项目将开发和测试一种便宜的，可重复使用的，非侵入性的设备，准确诊断先兆子痫。该器械采用单个ECG导联和脉搏血氧探头。软件算法从这两种技术中提取了80多个特征。该项目的阶段包括：1）使用台式系统收集100名先兆子痫和100名对照产妇在分娩和分娩中的数据; 2）使用回归和非线性技术改进初步算法; 3）开发设备的小型化原型并验证性能。对于II期，该装置将用于另外两项研究：（1）纵向数据收集， 产前诊所患者以改进算法，用于在发病前数月预测先兆子痫，以及（2）在分娩病房中大规模收集数据，用于开发区分轻度先兆子痫患者和将继续发展为严重疾病的患者的算法。最终目标是一种小型、廉价、可重复使用、非侵入性的设备，用于诊所、急诊室和产房，以预测和诊断先兆子痫，并区分未来的轻度和重度疾病。该设备的成本允许每次使用成本低至5美分。它将支持有关患者管理的更好决策，包括监测水平，交付计划和治疗干预。