Off-Body ECG Monitor Using Through-Clothing Electrodes

使用穿衣电极的离体心电图监护仪

• 批准号: 6835096
• 负责人: ANDREW D HIBBS
• 金额: $ 10万
• 依托单位: QUASAR, INC.
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-09-30 至 2005-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6835096
• 关键词: bioengineering /biomedical engineering; biomedical equipment development; cardiovascular disorder diagnosis; clinical biomedical equipment; clinical research; electrocardiographic monitor; electrocardiography; electrodes; human subject; infant human (0-1 year); middle childhood (6-11); preschool child (1-5); rapid diagnosis

DESCRIPTION (provided by applicant): The goal of this program is to determine whether a new class of sensor that measures electric potentials off the body at the microvolt level can provide a signal for pediatric ECG monitoring that is equivalent or better than a conventional, skin-contacting electrode. There are a number of important benefits of using this new technology for monitoring biopotentials in general, and these benefits are particularly significant for infants. Prior clinical measurements have been on adults, so Phase I we will first define electrode placement and mounting issues suitable for infants and children. We will also develop a rapid methodology to confirm correct operation to aid in putting on the electrodes. The principal Phase I activity will be to conduct a preliminary evaluation of the utility of the new electrode technology for routine pediatric electrocardiography on infants, using off-body electrodes in pockets sewn onto the outside of a "bunny suit". We will also conduct a separate initial assessment of ambulatory monitoring using sensors in pockets on the outside of a T-shirt. The methodology will be to conduct a simultaneous measurement with conventional, skin-contacting electrodes in the same single lead configuration to control for any patient-to-patient variation. In Phase II, more sophisticated studies will be performed to quantify the system performance in the presence of other medical devices and when operating through bandages. The trade-off between signal quality and electrode size, and pressure on the skin, will be quantified, and packaging will be developed to enable the electrodes to withstand standard hospital laundering. Based on these results, a system will be designed for pediatric monitoring applications. The culmination of Phase II will be a 50-subject clinical trial of the technology on infants and children.

描述（由申请人提供）： 该项目的目标是确定一种以微伏级测量人体电势的新型传感器是否可以为儿科心电图监测提供与传统皮肤接触电极等效或更好的信号。一般来说，使用这种新技术监测生物电有许多重要的好处，这些好处对婴儿来说尤其重要。 之前的临床测量是针对成人的，因此第一阶段我们将首先定义适合婴儿和儿童的电极放置和安装问题。我们还将开发一种快速方法来确认正确操作以帮助放置电极。第一阶段的主要活动将是对新电极技术在婴儿常规儿科心电图检查中的实用性进行初步评估，使用缝在“兔子服”外侧口袋中的离体电极。我们还将使用 T 恤外侧口袋中的传感器对动态监测进行单独的初步评估。该方法将在相同的单导联配置中使用传统的皮肤接触电极进行同步测量，以控制任何患者之间的差异。 在第二阶段，将进行更复杂的研究，以量化存在其他医疗设备以及通过绷带操作时的系统性能。信号质量和电极尺寸以及皮肤压力之间的权衡将被量化，并且将开发包装以使电极能够承受标准的医院洗涤。根据这些结果，将为儿科监测应用设计一个系统。第二阶段的高潮将是一项针对婴儿和儿童的 50 名受试者临床试验。