PILOT STUDY OF ONE-PIECE ELECTROCARDIOGRAM (ECG) SYSTEM FOR INFANTS

婴儿一体式心电图 (ECG) 系统的试点研究

• 批准号: 7952265
• 负责人: RUEY-KANG R CHANG
• 金额: $ 0.14万
• 依托单位: LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-12-01 至 2009-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7952265
• 关键词: Adult; Age; Chest; Child; Childhood; Clinical Research; Computer Retrieval of Information on Scientific Projects Database; Elderly; Electrocardiogram; Electrodes; Funding; Grant; Hospitals; Human; Infant; Institution; Lead; Long QT Syndrome; Morphologic artifacts; Newborn Infant; Nurses; Patients; Physicians; Pilot Projects; Research; Research Personnel; Resources; Risk; Screening procedure; Signal Transduction; Source; System; Testing; Time; United States National Institutes of Health; Work; design; prevent; programs; research clinical testing; research study; safety testing; sudden cardiac death

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Electrocardiogram(ECG) is a clinical test used frequently in hospitals and physician's offices. ECG is mostly performed in adults, especially elderly people. Current ECG machines and leads systems are designed for use inadults. Recently, there have been discussions in many nations, includingthe US, to implement a nationwide newborn ECG screening program to identify infantswith long QT syndrome who might be at risk for sudden cardiac death. The demand for pediatric ECG will likely increase significantly in the nearfuture. Therefore, there is an urgent need for simple, quick and error-proof ECG leads system for infants and children. Performingan ECG on an infant or a child can be quite challenging. Placing the leads on children is difficult because of limited space on the torso and they are frequently uncooperative. Furthermore, performing ECG on children using the complicated leads system by inexperienced nurses or technicians is prone to error, such as wrong leads placement, artifacts, and inadequate ECG signal acquisition. Therefore, there is clearly a need for a simple ECG leads system designed for pediatric patients which saves time and prevents human errors. The PI has invented a single chest strip ECG leads system to save time and prevent errors from leads placement. This ECG leads system is designed to work with current, commercial ECG machines. It is used to replace complicated ECG cables, but it does not alter the ECG machine. The purpose of this research study is to test a one-piece quick ECG electrode system for infants and compare with traditional ECG leads system. To test the safety and feasibility of the one-piece ECG system, a pilot study on 20 adults has recently been completed. This pilot study shows that the one-piece ECG system is safe and effective in adults. One-piece system shortened the lead placement time by 55% and total test duration by 43%. The majority of subjects in this pilot study prefer the new one-piece ECG system. The current study aims to test the safety and feasibility of the one-piece ECG system on 20 term infants 2 to 4 weeks of age.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 心电图是医院和医生办公室经常使用的临床检查. ECG主要用于成年人，尤其是老年人。 当前的ECG机器和导联系统被设计用于成人。最近，包括美国在内的许多国家都在讨论实施一项全国性的新生儿心电图筛查计划，以识别可能有心源性猝死风险的长QT综合征婴儿。 在不久的将来，对儿科ECG的需求可能会显著增加。因此，迫切需要一种简单、快速、防错的婴幼儿心电导联系统。 对婴儿或儿童进行心电图检查可能相当具有挑战性。 由于躯干上的空间有限，很难将电极导线放置在儿童身上，而且他们经常不合作。 此外，由经验不足的护士或技术人员使用复杂的导联系统对儿童进行ECG容易出现错误，例如错误的导联放置、伪影和ECG信号采集不足。 因此，显然需要一种为儿科患者设计的节省时间并防止人为错误的简单ECG导联系统。 PI发明了一种单胸带ECG导联系统，以节省时间并防止导联放置错误。 该ECG导联系统设计用于与当前商用ECG机器配合使用。 它用于替换复杂的心电图电缆，但不会改变心电图机。本研究的目的是测试一种婴儿一体式快速心电电极系统，并与传统的心电导联系统进行比较。 为了测试一体式心电图系统的安全性和可行性，最近完成了一项针对20名成年人的试点研究。 该初步研究表明，一体式心电图系统在成人中是安全有效的。 一体式系统缩短了55%的电极导线放置时间和43%的总测试时间。 本初步研究中的大多数受试者更喜欢新的一体式ECG系统。 本研究旨在测试20名2至4周大的足月婴儿使用一体式心电图系统的安全性和可行性。