Electrohysterogram-based sensor for non-invasive contraction monitoring with impr

基于宫腔电图的传感器，用于通过 impr 进行无创宫缩监测

• 批准号: 7482576
• 负责人: Neil R. Euliano
• 金额: $ 9.82万
• 依托单位: CONVERGENT ENGINEERING, INC.
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-06-15 至 2008-12-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7482576
• 关键词: Abdomen; Algorithms; Amplifiers; Caring; Catheters; Cervical; Clinical; Clinical Data; Compatible; Computer software; Data; Databases; Development; Discipline of Nursing; Discipline of obstetrics; Electrodes; Electronics; Expert Opinion; Fetal Monitoring; Frequencies; Goals; Hospitals; Infection; Invasive; Membrane; Methods; Monitor; Movement; Nature; Numbers; Nursing Staff; Obesity; Obstetric Delivery; Patients; Pilot Projects; Population; Positioning Attribute; Printing; Process; Public Health; Real-Time Systems; Research; Risk; Rupture; Signal Transduction; Standards of Weights and Measures; System; Time; Uterine Contraction; Uterus; Weight; Woman; base; computerized data processing; concept; design; non-invasive monitor; nursing intervention; pandemic disease; pressure; prototype; sensor; transmission process

DESCRIPTION (provided by applicant): The majority of obstetric deliveries in the US undergo continuous electronic uterine activity monitoring. Typically, an external tocodynamometer (strain gauge) is employed to provide the frequency and timing of uterine contractions. The reliability of this monitor depends on its proper positioning (which may be disturbed by patient movement), and the transmission of tension from the uterus to the sensor. In some patients, particularly the obese, the monitor may fail to detect contractions consistently. In others the monitor requires frequent repositioning by the nursing staff. The alternative uterine activity monitor is an intrauterine pressure catheter (IUPC), which is placed through the cervical os in the adequately dilated patient with ruptured membranes. While this monitor usually provides a more reliable signal, as well as quantitative information regarding intrauterine pressure, its invasive nature and increased risk of infection limit enthusiasm for its use. The obstetric suite is subject to the obesity pandemic in the US, and these women have an increased risk for labor problems, infections and other complications. Existing non-invasive uterine activity monitoring, while preferable to reduce the infection risk, is particularly unreliable in this population. The specific goal of the proposed research is to develop a reliable, non-invasive uterine activity monitor that is unaffected by obesity and requires less nursing intervention than the tocodynamometer. The end-product will be a smart cable that connects an existing labor monitor to an electrode array and converts the electrical activity of the uterus (electrohysterogram or EHG) into tocodynamometer signals compatible with existing monitors. Preliminary results obtained by our group indicate that the EHG can provide such a monitor, however these studies were conducted with 10 electrodes located across the maternal abdomen. We propose the following specific aims: Aim 1: Develop EHG signal processing and embedded software: Using retrospective data from our large database, signal processing algorithms to produce high quality contraction curves. A retrospective clinical interpretation study will be implemented to validate final signal processing system. Aim 2: Build EHG system hardware with embedded software: A prototype EHG amplifier system will be designed to interface directly to existing maternal-fetal monitors. The amplifier signal will be processed to create uterine activity curves that will be displayed in real-time and recorded for further analysis. Aim 3: Clinically evaluate the mini-array EHG uterine activity monitor: A 30-patient pilot study will be conducted to evaluate the reliability of the mini-array for monitoring contractions during active labor. The EHG uterine activity will be compared with that derived from the tocodynamometer and IUPC, and evaluated both electronically and by expert opinion. PUBLIC HEALTH RELEVANCE: The current method of non-invasive monitoring of uterine activity fails frequently, particularly in the obese patient. When this occurs, often clinicians must use an invasive intra- uterine pressure catheter that is particularly problematic in these patients since they are already at increased risk for infections. The development of an alternative, non-invasive monitor of uterine activity that performs better in the obese patient and at least as well in the normal-weight patient, will reduce infectious complications by limiting the need for invasive monitoring while requiring less nursing manipulation.

描述（由申请人提供）：美国大多数产科交付都经过连续的电子子宫活性监测。通常，采用外部造物量学计（应变计）来提供子宫收缩的频率和时机。该监视器的可靠性取决于其适当的定位（可能受到患者运动的干扰）以及从子宫向传感器的张力传播。在某些患者中，尤其是肥胖症患者，监测仪可能无法始终如一地检测到收缩。在其他情况下，监视器需要经常由护理人员重新定位。替代子宫活性监测仪是宫内压导管（IUPC），它通过膜破裂的患者充分扩张的患者中的宫颈OS放置。虽然该监视器通常提供更可靠的信号，以及有关宫内压力的定量信息，其侵入性和增加感染风险限制其使用的风险。在美国，产科套房受肥胖大流行的约束，这些妇女患有劳动问题，感染和其他并发症的风险增加。在该人群中，现有的非侵入性子宫活性监测虽然优选降低感染风险，但在该人群中尤其不可靠。拟议的研究的具体目标是开发一个可靠的，非侵入性的子宫活性监测仪，该监测仪不受肥胖的影响，并且需要比TocodyNegemmeter更少的护理干预措施。最终产品将是一根智能电缆，它将现有的人工监视器连接到电极阵列，并将子宫（ElectroHysteragram或eHG）的电活动转换为与现有监视器兼容的TocodyNammens信号。我们组获得的初步结果表明，EHG可以提供这样的监视器，但是这些研究是用位于母体腹部的10个电极进行的。我们提出以下具体目标： AIM 1：开发EHG信号处理和嵌入式软件：使用大型数据库中的回顾性数据，信号处理算法来产生高质量的收缩曲线。将实施回顾性临床解释研究以验证最终信号处理系统。 AIM 2：使用嵌入式软件构建EHG系统硬件：原型EHG放大器系统将设计为直接与现有的母亲 - 露天监视器接口。放大器信号将进行处理以创建子宫活动曲线，该曲线将实时显示并记录以进行进一步分析。 AIM 3：临床评估Mini-Araray EHG子宫活动监测仪：将进行30名患者试点研究，以评估在积极劳动期间监视收缩的微型阵列的可靠性。 EHG子宫活性将与源自托管动力学仪和IUPC得出的活性进行比较，并以电子方式和专家意见进行了评估。公共卫生相关性：当前对子宫活动的非侵入性监测方法经常失败，尤其是在肥胖患者中。发生这种情况时，临床医生通常必须使用侵入性的子宫内压导管，这在这些患者中尤其有问题，因为它们已经处于感染风险增加。在肥胖患者中及至少在正常体重患者中表现更好的子宫活性的替代性无创的监测器的发展将通过限制进行侵入性监测的需求而减少需要减少护理手术的需求，从而减少感染性并发症。