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.

项目摘要 美国每年有2.4万例死产，每年有260万例死产 在世界范围内，在过去十年中没有显著下降。胎儿心率异常，如 作为长QT综合征，被认为在这些死亡中起着重要作用，并可能导致3- 10%的原因不明死产。这还不包括已知的胎儿心律失常，后者影响1-3% 每年的怀孕率。心磁图是检测这些疾病的金标准， 但不便于携带，也不适用于广泛使用。其他可用的工具，如超声波和 心电地形图不能测量诊断和指导治疗所需的间隔 危及生命的心律失常。诊断和指导治疗心律失常的理想工具是 一张心电图机。不幸的是，临床医生并没有广泛使用现有的胎儿 出于各种原因，心电图仪(Fecg)并不能在所有 妊娠时，可错过短暂的心律失常，在实际节律和显示之间有延迟 节律性差，多胎时不起作用，缺乏重要间歇的分辨率。 我们的团队在一项正在进行的R21资助的研究中提炼了一个胎儿心电原型。这项提议将 在前期工作的基础上，创建可利用的胎儿心电的紧凑型版本 更广泛地应用于非卧床环境。在这项建议中，我们的目标是： 1.开发紧凑型功放系统 2.开发新的用户界面 3.在10名怀孕22-40岁的孕妇中对新系统进行试点测试 孕周，以确定它是否与目前的 在胎心电信号质量和CTI测量方面的系统。 如果成功，胎儿心脏病学家可以使用这种工具来诊断和治疗已知和潜在的胎儿 心律不齐。在全球范围内，它可以作为一种低成本的工具来筛查导致心律失常的 死产，并监测胎儿在手术中的危害，产妇用药，以及 胎儿干预。临床应用这一关键诊断工具将是 胎儿心脏病学领域。