Off-Body ECG Monitor Using Through-Clothing Electrodes

描述（由申请人提供）： 该项目的目标是确定一种新型传感器（可测量微伏级的人体电位）是否能为儿科ECG监测提供与传统皮肤接触电极相当或更好的信号。一般来说，使用这种新技术监测生物电位有许多重要的好处，这些好处对婴儿尤其重要。 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的操作，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中的实用性进行初步评价，使用缝在“兔子服”外面的口袋中的离体电极。我们还将使用T恤外部口袋中的传感器对动态监测进行单独的初步评估。该方法将使用相同单导线配置中的传统皮肤接触电极进行同步测量，以控制任何患者间差异。 在第二阶段，将进行更复杂的研究，以量化系统在存在其他医疗器械和通过绷带操作时的性能。信号质量和电极尺寸以及皮肤压力之间的权衡将被量化，包装将被开发，以使电极能够承受标准的医院清洗。基于这些结果，将设计一个用于儿科监护应用的系统。第二阶段的高潮将是对婴儿和儿童进行50名受试者的临床试验。

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.