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

开发基于云的智能手表应用程序网络，以改善心脏骤停反应期间的心肺复苏。

• 批准号: 10323236
• 负责人: Adam LaPrad
• 金额: $ 29.84万
• 依托单位: XIMIO HEALTH, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-01 至 2023-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10323236
• 关键词: Accelerometer; Address; Adherence; Adult; Algorithms; American Heart Association; Automobile Driving; Basic Life Support; Cardiopulmonary Resuscitation; Chest; Clinical; Clinical Data; Code; Collaborations; Communication; Data; Data Analyses; Databases; Defibrillators; Development; Emergency Situation; Enrollment; Ensure; Event; Feasibility Studies; Feedback; Guidelines; Health; Health Professional; Heart Arrest; Hospitals; Human Resources; In Situ; Institutional Review Boards; Intervention; Intuition; Link; Manikins; Measures; Memory; Mission; Muscle; Network-based; Participant; Pathway interactions; Patients; Peer Review; Performance; Phase; Process; Protocols documentation; Provider; Readiness; Reporting; Role; Secure; Small Business Innovation Research Grant; Survival Rate; System; Technology; Testing; Time; Training; Vision; Work; Wrist; base; care systems; cloud based; data sharing; design; experience; feasibility testing; first responder; improved; mathematical algorithm; member; mortality; peer; point of care; prototype; response; sensor; simulation; smart watch; tool; wearable device

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.

项目摘要 每年，估计有530,000名成年人死于美国心脏骤停。死亡率极高 - 院外事件为90％，院内事件为75％，并且主要保持不变。 十年。我们可以而且应该做得更好。在2020年的指南中，美国心脏协会（AHA）指出 早期高质量的心肺复苏（CPR）是患者最关键的救生干预措施 在心脏骤停。但是，即使训练有素的救援人员，也很难提供高质量的胸部压缩。 高质量的CPR建立在强大的常规培训和以性能为中心的汇报为基础上。但是，大多数救援人员 仍然每两年训练一次。尽管AHA发起了更频繁培训的举措，但CPR 在培训中使用的辅助工具在临床反应期间仍未参与救援人员。最终，救援人员 要么仅依靠他们的记忆，要么使用当前基于除颤器的CPR AIDS，这些辅助工具在 提高CPR质量。此外，性能数据仍在除颤器中构建，并且不常用 用于同行质量评论；因此，无法衡量当前的培训计划是否正在改善CPR 质量。在心脏骤停期间，需要高度功能的护理工具来协助从业者 响应以及允许在现场设置进行定期培训并提供数据丰富的性能的工具 - 专注的同行汇报。 Ximio Health，Inc。开发首个智能手表基本生活支持的提案 （BLS）在培训和临床反应中使用应用。我们将使用实时设计BLS应用 对AHA协议和实时CPR深度和评分性能反馈的决策支持，使救援人员能够 立即准备在紧急情况下提供高质量的心肺复苏术。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并一起响应代码。最后，云 - 基于安全的数据库将允许同行汇报和评论，这意味着救援人员可以跟踪其性能 改进。在第一阶段，我们将首先开发BLS应用程序的全功能原型。然后我们将进行 使用CPR Manikins建立BLS应用程序的概念证明的一项IRB批准的可行性研究 性能和实用性作为CPR援助。这项研究将在三个用户组中招募30名成年参与者：In- 医院BLS认证的医疗保健专业人员，院外BLS认证的急救人员（例如EMT）和 非认证人员。成功达到概念证明后，第二阶段将包括开发和 设计控件中BLS应用程序的设计验证测试，然后进行FDA 510（k）清除BLS 应用程序和随后的应用程序和功能的开发，以实现我们的主要使命基于云 互连的智能手表应用程序网络，以改善心脏骤停质量。我们的总体 假设是，救援人员和组织将提高其CPR质量，并最终通过 通过我们的交互式可穿戴技术实现了连续的质量改进系统。