Development of a cloud-based network of smartwatch applications to improve cardiopulmonary resuscitation during cardiac arrest response.

项目摘要 据估计，美国每年有53万成年人死于心脏骤停。死亡率过高-- 90%用于院外活动，75%用于院内活动，并且在过去的几年中基本保持不变 十年。我们能够而且应该做得更好。美国心脏协会(AHA)在其2020年的指导方针中表示 早期高质量的心肺复苏(CPR)是患者最关键的挽救生命的干预措施 心脏骤停。然而，即使对于训练有素的救援人员来说，提供高质量的胸部按压也是困难的。 高质量的CPR建立在强有力的定期培训和注重绩效的汇报的基础上。然而，大多数救援人员 现在仍然每两年才训练一次。尽管AHA发起了更频繁的培训计划，但CPR 在训练中使用的艾滋病仍然不会在临床反应期间陪伴救援者。最终，救援人员 要么完全依靠他们的记忆，要么使用目前基于除颤器的CPR辅助设备，这些辅助设备在 提高心肺复苏质量。此外，性能数据仍隐藏在除颤器中，不会常规使用 对于同行质量审查；因此，无法衡量当前的培训举措是否正在改进CPR 质量。在心脏骤停期间，需要高功能的护理点工具来帮助医生 响应，以及允许在现场环境中进行定期培训并提供丰富数据性能的工具- 有重点的同事汇报。西妙健康公司提议开发第一款支持智能手表的基本生命支持 (BLS)应用程序，用于培训和临床响应。我们将实时设计BLS应用程序 对AHA协议的决策支持以及实时CPR深度和评级性能反馈，使救援人员能够 在紧急情况下立即准备好提供高质量的心肺复苏。通过将BLS应用程序链接到实时 基于云的网络，我们将使团队能够一起训练，一起响应代码。最后，一朵云-- 基于安全的数据库将允许同行汇报和审查，这意味着救援人员可以跟踪他们的表现 改进。在第一阶段，我们将首先开发一个全功能的BLS应用程序原型。然后我们将进行 IRB批准的使用CPR模特建立BLS应用程序概念验证的可行性研究 作为心肺复苏辅助设备的性能和实用性。这项研究将招募30名成年参与者，分别来自三个用户组： 医院BLS认证的医疗专业人员、出院BLS认证的急救人员(例如急救人员)，以及 未经认证的人员。在成功完成概念验证后，第二阶段将包括开发和 在设计控制下对BLS应用程序进行设计验证测试，随后FDA 510(K)批准BLS 应用程序以及后续应用程序和功能的开发，以实现我们基于云的 互联智能手表应用网络，提高心脏骤停质量。我们最重要的是 假说是救援人员和组织将提高他们的CPR质量，并最终通过以下方式提高存活率 实施由我们的交互式可穿戴技术实现的持续质量改进系统。

Project Summary Each year, an estimated 530,000 adults die of cardiac arrest in the USA. Mortality rates are excessively high – 90% for out-of-hospital events and 75% for in-hospital events – and have remained mostly unchanged for over a decade. We can and should do better. In their 2020 Guidelines, the American Heart Association (AHA) states that early high-quality cardiopulmonary resuscitation (CPR) is the most critical lifesaving intervention for a patient in cardiac arrest. However, delivering high-quality chest compressions is difficult even for well-trained rescuers. High-quality CPR is built on robust regular training and performance-focused debriefing. However, most rescuers still train just once every two years. Though AHA has launched initiatives for more frequent training, the CPR aids that are used in training still do not accompany the rescuer during clinical responses. Ultimately, rescuers either rely solely on their memory, or use current defibrillator-based CPR aids that have questionable benefit in improving CPR quality. In addition, performance data remains buried in defibrillators and are not routinely used for peer quality reviews; thus, there is no way to measure if the current training initiatives are improving CPR quality. There is a need for highly functioning point-of-care tools to assist practitioners during a cardiac arrest response, as well as tools that allow for regular training in in-situ settings and provide data-rich performance- focused peer debriefing. XiMiO Health, Inc. proposes to develop the first smartwatch-enabled Basic Life Support (BLS) application for use both in training and clinical response. We will design the BLS App with real-time decision support to AHA protocols and real-time CPR depth and rate performance feedback, enabling a rescuer to be immediately ready to provide high-quality CPR in an emergency. By linking the BLS App to a real-time cloud-based network, we will enable teams to train together and respond to codes together. Lastly, a cloud- based secure database will allow for peer debriefing & reviews, meaning rescuers can track their performance improvements. In Phase I, we will first develop a fully functional prototype of the BLS App. We will then conduct an IRB-approved feasibility study using CPR manikins to establish proof-of-concept of the BLS App’s performance and utility as a CPR aid. The study will enroll 30 adult participants across three user groups: in- hospital BLS-certified healthcare professionals, out-of-hospital BLS-certified first responders (e.g., EMTs), and noncertified personnel. Upon successfully reaching proof-of-concept, Phase II will include development and design verification testing of the BLS App under Design Controls, followed by FDA 510(k) clearance of the BLS App and development of subsequent apps and functionality to achieve our principal mission of a cloud-based network of interconnected smartwatch applications for cardiac arrest quality improvement. Our overarching hypothesis is that rescuers and organizations will improve their CPR quality, and ultimately, survival rates by implementing a continuous quality improvement system enabled by our interactive wearable technology.