HeartMap Dynamic Registry Pilot

项目摘要 主要目标 本HeartMap动态登记研究的长期目标是确保自动体外除颤器的安全性 （AED）通过执行上市后监督。AED是用于治疗院外心脏病的医疗器械， 逮捕（OHCA）。AED分布在预期接近心脏骤停现场的位置， 周期性地从一个地方移动到另一个地方。有120万个预先存在的AED， 每年安装新设备。随着越来越多的AED被安装在社区环境中， 美国食品和药物管理局收到的医疗器械报告数量不断增加。重要的是 没有广泛部署的方法来跟踪它们的位置和在社区环境中的使用。为全国性的 AED监测系统，这项试点研究将评估实施和维护一个 动态注册表，用于监测AED的位置和使用。 我们的主要目的是通过估计注册AED的损耗来建立追踪AED的可行性。 死亡率定义为进入研究后6个月内位置或状态未知的AED比例。 登记处。 次要目的 我们的第二个目标是评估权责发生制和联系。应计费用定义为 标记有UDI并在登记研究中登记。关联定义为登记研究中AED的比例 链接到：描述现有AED的社交媒体数据库;描述现有AED的临床电子数据库 OHCA治疗患者的护理;以及住院患者的电子病历。 方法 设计：在社区环境中对预先存在和新安装的AED进行前瞻性队列研究。 本试点研究将在华盛顿州的西雅图和宾夕法尼亚州的费城县实施。 包括的AED人群为： （a）在社区环境中预先存在， I.由制造商或经销商标识;或 二.通过众包技术确定。 B）社区环境中新安装的; I.由业主在安装时确定。 纳入的患者将接受OHCA治疗： a）由有组织的EMS人员进行评估，并接受外部除颤尝试（由非专业人员、警察或 EMS），或 B）由有组织的EMS人员进行胸外按压，以及 （c）运送至参与的接收医院。 关注的暴露个体AED将使用唯一器械标识符（UDI）进行标记。此UDI 包括具有二维矩阵码（QR码，DensoWave Inc.，Chita-gun，Japan）。然后 UDI以及器械的位置和状态使用开源软件记录， 并且该信息经由互联网以真实的时间传递到数据库 （临时专利号61/498，424）。数据库中的设备特定信息可以动态更新 通过在每次使用AED时重新扫描二维矩阵码。 分析由于这是一项描述应计和自然减员特征的可行性研究， 允许因疗效或无效而停止研究的分析。这些数据将被定期监测 由独立的DSMB进行，以确保研究完整性和患者安全性。自然减员率汇总如下： 二项比例将按照试点的建议，对次级措施进行总结 问题研究 样本量我们预计三个月的入组将产生2，000个带有UDI的AED。如果90%的登记者 AED在6个月时已知，95%置信区间将提供足够的精度来拒绝磨损 低于0.886。如果80%的入组AED在6个月时已知，则将有足够的精度拒绝 流失率低于0.781。

PROJECT SUMMARY PRIMARY AIMS The long-term goal of this HeartMap Dynamic Registry is to ensure safety of automated external defibrillators (AEDs) by performing postmarket surveillance. AEDs are medical devices used to treat out-of-hospital cardiac arrest (OHCA). AEDs are distributed in locations anticipated to be close to the scene of cardiac arrest and are moved periodically from one location to another. There are 1.2 million pre-existing AEDs, and about 180,000 new devices installed annually. As increased numbers of AEDs have been installed in community settings, the Food and Drug Administration has received increased numbers of medical device reports. Importantly, there is no widely-deployed method of tracking their location and use in community settings. To plan for a national AED surveillance system, this pilot study will evaluate the feasibility of implementation and maintenance of a dynamic registry for surveillance of AED location and use. Our primary aim is to establish the feasibility of tracking AEDs by estimating attrition of registered AEDs. Attrition is defined as the proportion of AEDs that have unknown location or status six months after entry into the registry. SECONDARY AIMS Our secondary aims are to assess accrual and linkage. Accrual is defined as the proportion of AEDs that are tagged with a UDI and enrolled in the registry. Linkage is defined as the proportion of AEDs in the registry linked to: a social media database that describes pre-existing AEDs; a clinical electronic database that describes care for patients treated for OHCA; and an electronic medical record for hospitalized patients. METHODS Design Prospective cohort study of pre-existing and newly-installed AEDs in community settings. Setting This pilot study will be implemented in Seattle, WA and Philadelphia County, PA. Population Included AEDs will be those: a) Pre-existing in community settings and i. Identified by manufacturer or distributor; or ii. Identified by crowdsourcing techniques. b) Newly installed in community setting; i. Identified by owner during at time of installation. Included patients will be those treated for OHCA: a) Evaluated by organized EMS personnel and receive attempts at external defibrillation (by lay, police or EMS), or b) Receive chest compressions by organized EMS personnel, and c) Transported to a participating receiving hospital. Exposure of Interest Individual AEDs will be tagged with a Unique Device Identifier (UDI). This UDI consists of a label with a two-dimensional matrix code (QR code, Denso Wave Inc., Chita-gun, Japan). Then the UDI as well as the location and status of the device are recorded using open-source software native to contemporary smartphones and this information is passed to a database in real time via the internet (Provisional Patent # 61/498,424). The device-specific information in the database can be updated dynamically by rescanning the two-dimensional matrix code at each use of the AED. Analysis As this is a feasibility study to characterize accrual and attrition, there will be no formal interim analyses that would allow stopping the study for either efficacy or futility. The data will be monitored regularly by an independent DSMB to ensure study integrity and patient safety. The attrition rate will be summarized as a binomial proportion. Secondary measures will be summarized descriptively, as recommended for pilot studies. Sample Size We anticipate enrollment for three months will yield 2,000 AEDs with UDIs. If 90% of enrolled AEDs are known at six months, a 95% confidence interval will provide sufficient precision to reject an attrition rate below 0.886. If 80% of enrolled AEDs are known at six months, there will be sufficient precision to reject an attrition rate below 0.781.