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.

项目总结