Development of a portable beat-to-beat fetal ECG system

便携式胎儿心电图系统的开发

• 批准号: 10483922
• 负责人: Anita Krishnan
• 金额: $ 25.63万
• 依托单位: AUSCULTECH DX, LLC
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-01-18 至 2024-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10483922
• 关键词: Affect; Amplifiers; Arrhythmia; Birth; Cardiac; Cardiology; Cardiotocography; Cessation of life; Child; Clinical; Collaborations; Computer software; Data; Detection; Development; Devices; Diagnosis; Diagnostic tests; Discipline of obstetrics; Disease; Early Diagnosis; Electrocardiogram; Emotional; Engineering; Enrollment; Evaluation; Fetal Death; Fetal Heart; Fetal Monitoring; Fetal Version; Fetus; Frequencies; Funding; Future; Goals; Infant; Inpatients; Intervention; Life; Link; Long QT Syndrome; Maternal-fetal medicine; Measurement; Measures; Medical center; Monitor; National Institute of Child Health and Human Development; Operative Surgical Procedures; Parents; Patients; Performance; Pharmaceutical Preparations; Phase; Play; Pregnancy; Pregnant Women; Process; Provider; Research; Resolution; Role; Scientist; Second Pregnancy Trimester; Signal Transduction; Small Business Technology Transfer Research; Specialist; Survival Rate; System; Technology; Technology Transfer; Test Result; Testing; Third Pregnancy Trimester; Time; Toxicity Tests; Translating; United States; United States National Institutes of Health; Universities; Visualization; Work; cardiac magnetic resonance imaging; clinical practice; cohort; cost; data acquisition; diagnostic tool; experience; fetal; fetus at risk; heart rhythm; infant death; laptop; neonatal death; pilot test; portability; prototype; signal processing; skills; software development; stillbirth; time interval; tool; ultrasound

Project Summary There are 24,000 stillbirths per year in the United States, and 2.6 million stillbirths per year worldwide, with no significant decrease in the last decade. Abnormal fetal heart rhythms, such as long QT syndrome, are thought to play an important role in these deaths, and may cause 3- 10% of unexplained stillbirths. This is in addition to known fetal arrhythmias, which affect 1-3% of pregnancies per year. A magnetocardiogram is the gold standard to detect these disorders, but is not portable or practical for widespread use. Other available tools such as ultrasound and cardiotocography cannot measure the intervals needed to diagnose and guide management of life threatening arrhythmias. The ideal tool for diagnosing and guiding therapy for arrhythmias is an electrocardiogram (ECG). Unfortunately, clinicians do not widely use the existing fetal electrocardiogram (fECG) devices for a variety of reasons: they do not work throughout all of gestation, can miss brief arrhythmias, have a delay between the actual rhythm and displayed rhythm, do not work in multiple gestations, and lack resolution of important intervals. Our team has refined a prototype fECG during an ongoing R21 funded study. This proposal will build on our preliminary work to create a compact version of the fECG which can be utilized more widely in ambulatory settings. In this proposal we aim to: 1. Develop a compact amplifier system 2. Develop a new user interface 3. Pilot test the new system in a cohort of ten pregnant women carrying fetuses 22-40 weeks gestation to determine whether it is comparable to or superior to the current system in fECG quality and CTI measurements. If successful, fetal cardiologists could use this tool to diagnose and treat known and latent fetal arrhythmias. Globally, it could serve as a low cost tool to screen for arrhythmias that lead to stillbirth and to monitor fetuses for compromise during surgery, maternal medication use, and fetal interventions. Clinically implementing this critical diagnostic tool will be a landmark in the field of fetal cardiology.

项目概要 美国每年有24,000个死产，每年有260万个死产 在全球范围内，过去十年没有显着下降。胎儿心律异常，例如 长 QT 综合征被认为在这些死亡中发挥着重要作用，并可能导致 3- 10% 的不明原因死产。这还不包括已知的胎儿心律失常，影响 1-3% 每年怀孕次数。心磁图是检测这些疾病的金标准， 但不便于携带或不适合广泛使用。其他可用的工具，例如超声波和 心宫监护不能测量诊断和指导管理所需的时间间隔 危及生命的心律失常。诊断和指导心律失常治疗的理想工具是 心电图 (ECG)。不幸的是，临床医生并没有广泛使用现有的胎儿 心电图 (fECG) 设备出于多种原因：它们不能在所有时间都工作 妊娠期，可能会错过短暂的心律失常，实际心律与显示心律之间存在延迟 节律，在多胎妊娠中不起作用，并且缺乏重要间隔的分辨率。 我们的团队在 R21 资助的正在进行的研究中改进了 fECG 原型。该提案将 以我们的前期工作为基础，创建可供使用的 fECG 的紧凑版本 更广泛地应用于流动环境。在本提案中，我们的目标是： 1. 开发紧凑型放大器系统 2. 开发新的用户界面 3. 在 10 名怀有 22-40 岁胎儿的孕妇中对新系统进行试点测试 妊娠周数以确定是否与当前妊娠相当或优于 fECG 质量和 CTI 测量系统。 如果成功，胎儿心脏病专家可以使用该工具来诊断和治疗已知和潜在的胎儿心脏病 心律失常。在全球范围内，它可以作为一种低成本工具来筛查导致心律失常的疾病 死产并监测胎儿在手术期间的损害、母亲的药物使用以及 胎儿干预。临床上实施这一关键的诊断工具将成为该领域的一个里程碑 胎儿心脏病学领域。