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

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
依托单位国家:
美国
项目类别:
财政年份:
2008
资助国家:
美国
项目状态:
已结题
起止时间:
2008-12-01 至 2009-11-30

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中文摘要
翻译
这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金, 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 心电图是医院和S医生办公室常用的一项临床检查。心电检查多见于成年人,尤其是老年人。目前的心电图机和导联系统都是为成年人设计的。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筛查计划,以确定患有长QT综合征的婴儿可能有心脏性猝死的风险。在不久的将来,对儿科心电的需求可能会大幅增加。因此,迫切需要一种简单、快速、防错的婴幼儿心电导联系统。 在婴儿或儿童身上进行心电检查可能是相当具有挑战性的。由于躯干上的空间有限,很难将引线放在儿童身上,而且他们经常不合作。此外,由缺乏经验的护士或技术人员使用复杂的导联系统对儿童进行心电检查容易出错,如导联放置错误、伪影和心电信号采集不充分等。因此,显然有必要为儿科患者设计一种简单的心电导联系统,以节省时间并防止人为错误。 PI发明了一种单胸带心电导联系统,以节省时间并防止导联放置错误。该心电导联系统可与现有的商用心电图机配合使用。它被用来取代复杂的心电电缆,但它不会改变心电图机。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名成年人的初步研究。这项初步研究表明,一体式心电系统在成人中是安全有效的。一体式系统缩短了55%的引线放置时间和43%的总测试持续时间。在这项初步研究中,大多数受试者更喜欢新的一体式心电系统。 本研究旨在对20名2至4周的足月儿进行单片心电系统的安全性和可行性测试。
英文摘要
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.
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