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.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目及 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 心电图(ECG)是医院和医生办公室经常使用的临床测试。 心电图检查主要在成人中进行，尤其是老年人。 目前的心电图机和导联系统是为成人使用而设计的。最近，包括美国在内的许多国家都在讨论实施全国性新生儿心电图筛查计划，以识别可能存在心源性猝死风险的长 QT 综合征婴儿。 在不久的将来，对儿科心电图的需求可能会显着增加。因此，迫切需要一种简单、快速、防错的婴幼儿心电图导联系统。 对婴儿或儿童进行心电图检查可能非常具有挑战性。 由于躯干空间有限，给儿童放置导线很困难，而且他们常常不合作。 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心电图检查很容易出现错误，例如导联放置错误、伪影和心电图信号采集不足。 因此，显然需要一种专为儿科患者设计的简单心电图导联系统，以节省时间并防止人为错误。 PI 发明了单胸带心电图导联系统，以节省时间并防止导联放置错误。 该心电图导联系统设计用于与当前的商用心电图机配合使用。 它用于取代复杂的心电图电缆，但不会改变心电图机。本研究的目的是测试一种用于婴儿的一体式快速心电图电极系统，并与传统心电图导联系统进行比较。 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。 这项试点研究表明，一体式心电图系统对成人来说是安全有效的。 一件式系统将引线放置时间缩短了 55%，将总测试持续时间缩短了 43%。 这项试点研究中的大多数受试者更喜欢新的一体式心电图系统。 目前的研究旨在对 20 名 2 至 4 周龄的足月婴儿测试一体式心电图系统的安全性和可行性。