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24,000个死产，每年有260万个死产 在全球范围内，在过去的十年中没有显着减少。异常的胎儿心律，这样 长期以来，QT综合征被认为在这些死亡中起着重要作用，可能会导致3- 10％无法解释的死产。这是已知的胎儿心律不齐的补充，影响1-3％ 每年怀孕。心电图是检测这些疾病的黄金标准， 但对于广泛使用而不是便携式或实用性。其他可用工具，例如超声波和 心电图学无法衡量诊断和指导管理所需的间隔 威胁性心律失常。诊断和指导性心律失常的理想工具是 心电图（ECG）。不幸的是，临床医生不会广泛使用现有的胎儿 心电图（FECG）设备的原因有多种原因：它们不整合所有 妊娠，可能会错过短暂的心律不齐，在实际节奏之间延迟并显示 节奏，不要在多种妊娠中起作用，也缺乏重要的间隔。 我们的团队在正在进行的R21资助研究中完善了FECG的原型FECG。该提议将 建立在我们的初步工作的基础上，以创建可以使用的紧凑版本的FECG版本 在门诊环境中更广泛。在此提案中，我们的目标是： 1。开发紧凑的放大器系统 2。开发新的用户界面 3。试点测试新系统的两名携带胎儿的孕妇22-40 妊娠周以确定它是可比还是优于电流 FECG质量和CTI测量的系统。 如果成功，胎儿心脏病专家可以使用此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，它可以用作筛查心律不齐的低成本工具 死胎并监测手术期间妥协的胎儿，使用产妇用药和 胎儿干预。临床上实施此关键诊断工具将成为 胎儿心脏病学领域。