Sensing lead for denoising ambulatory ECGs and false positive event reduction

描述（由申请人提供）：带内伪影和噪声是从皮下和体表ECG的动态记录中提取准确、可靠和可重复信息的主要障碍。每年有超过400万患者经历心律失常的动态评估，带内伪影和噪声是一个紧迫的，广泛的挑战。例如，在临床护理中，假阳性心律失常检测的高发生率可能导致需要昂贵的手动过度读取，从而导致较差的操作效率和较高的护理成本。此外，噪声可以掩盖P波，从而阻止心房活动的评估，这是做出正确诊断和寻求最有效治疗策略的重要因素。这个问题在药物安全性和有效性的临床研究中也很重要（评估新药和获批药物对公共卫生影响的基础），因为噪声会引入间隔测量的可变性，这反过来会增加样本量和成本，也会影响信息质量。 成功完成这一拟议的多相SBIR研究计划将产生一种通用的ECG传感导线，该导线将提供相对无噪声的信号，用于在市售的动态ECG监护仪上进行记录。这将显著提高美国每年400万寻求心律失常治疗的患者的医生可获得的诊断信息的质量。改进的诊断信息将导致更明智的治疗决策，改善患者的生活质量，并以更低的成本提供更高质量的护理。 具体而言，第一阶段将专注于研究一种新颖的、经过验证的、正在申请专利的算法的优化方法，该算法用于从ECG信号中去除带内噪声，而不影响潜在的信号形态和保真度，称为多域滤波TM。将研究创新的方法来实现该算法的关键数学功能，使用有效的数值方法和计算技术。该算法将在嵌入式代码中实现，并在目标微处理器系统上进行测试，以评估计算效率，功耗，降噪性能和保真度。还将进行测试，以估计当与最先进的动态ECG监测设备一起使用时，去噪对心律失常事件检测准确性的影响。 公共卫生相关性：成功完成这一拟议的多相SBIR研究计划将产生一种通用的ECG传感导线，该导线将提供相对无噪声的信号，用于在市售的动态ECG监护仪上进行记录。这将显著提高美国每年400万寻求心律失常治疗的患者的医生可获得的诊断信息的质量。改进的诊断信息将导致更明智的治疗决策，改善患者的生活质量，并以更低的成本提供更高质量的护理。

DESCRIPTION (provided by applicant): In-band artifact and noise present a major obstacle to extracting accurate, reliable, and repeatable information from ambulatory recordings of subcutaneous and surface ECGs. With more than 4 million patients a year experiencing ambulatory evaluations for cardiac arrhythmia, in-band artifact and noise is an urgent, wide-reaching challenge. In clinical care, for example, the high incidence of false positive arrhythmia detections can result in the need for expensive manual over-read, leading to poor operational efficiencies and higher cost of care. In addition, noise can mask P-waves, thereby preventing evaluation of atrial activity, an important factor in making the correct diagnosis and pursuing the most effective treatment strategy. This issue is also important in clinical research on drug safety and effectiveness (the basis for assessing public health impacts of new and approved medications) because noise introduces variability in interval measurements which, in turn, increases sample size and cost and also compromises the quality of information. Successful completion of this proposed multiphase SBIR research program will result in a universal ECG sensing lead that will provide relatively noise free signals for recording on commercially available ambulatory ECG monitors. This will result in a significant improvement in the quality of diagnostic information available to physicians that care for the 4 million patients that seek treatment for cardiac arrhythmias each year in the US. The improved diagnostic information will lead to more informed therapeutic decisions, improved patient quality of life, and higher quality care delivered at a lower cost. Specifically, Phase I will focus on researching approaches to optimization of a novel, proven, and patent- pending algorithm for removing in-band noise from ECG signals without compromising underlying signal morphology and fidelity, referred to as Multi-Domain FilteringTM. Innovative approaches will be researched to implement critical mathematical functions of this algorithm using efficient numerical methods and computational techniques. The algorithm will be implemented in embedded code and tested on targeted microprocessor systems to evaluate computational efficiency, power consumption, noise reduction performance, and fidelity. Testing will also be performed to estimate the impact of denoising on arrhythmia event detection accuracy when used with state-of-the-art ambulatory ECG monitoring devices. PUBLIC HEALTH RELEVANCE: Successful completion of this proposed multiphase SBIR research program will result in a universal ECG sensing lead that will provide relatively noise free signals for recording on commercially available ambulatory ECG monitors. This will result in a significant improvement in the quality of diagnostic information available to physicians that care for the 4 million patients that seek treatment for cardiac arrhythmias each year in the US. The improved diagnostic information will lead to more informed therapeutic decisions, improved patient quality of life, and higher quality care delivered at a lower cost.