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 在美国，每年估计有53万成年人死于心脏骤停。死亡率非常高- 90%为院外事件，75%为院内事件，并且在超过10年的时间内基本保持不变。 十几年我们可以而且应该做得更好。美国心脏协会（AHA）在其2020年指南中指出， 早期高质量的心肺复苏（CPR）是对患者最重要的救生干预措施， 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。 高质量的心肺复苏术建立在强有力的定期培训和以绩效为中心的汇报之上。然而，大多数救援人员 仍然每两年训练一次。尽管AHA已经发起了更频繁的培训计划， 在临床反应期间，在训练中使用的辅助设备仍然不伴随救助者。最终，救援人员 要么仅仅依靠他们的记忆，要么使用目前基于心肺复苏术的辅助设备， 提高CPR质量。此外，性能数据仍然隐藏在数据库中，并且不经常使用 同行质量审查;因此，没有办法衡量目前的培训计划是否正在改善CPR 质量.需要高度功能化的即时护理工具来在心脏骤停期间协助从业者 响应，以及允许在现场环境中进行定期培训并提供数据丰富的性能的工具- 专注的同事汇报XiMiO Health，Inc.建议开发第一个支持智能手表的基本生命支持系统 (BLS)应用于培训和临床反应。我们将设计BLS应用程序与实时 对AHA协议的决策支持以及实时CPR深度和速率性能反馈， 立即准备好在紧急情况下提供高质量的CPR。通过将BLS应用程序链接到实时 通过基于云的网络，我们将使团队能够共同培训并共同响应代码。最后，一片云-- 基于安全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他们的表现 改进.在第一阶段，我们会先开发一个功能完备的“劳工统计调查”应用程式原型，然后再进行 IRB批准的可行性研究，使用CPR人体模型建立BLS应用程序的概念验证 性能和实用性作为CPR援助。该研究将招募30名成年参与者，分为三个用户组： 医院BLS认证的医疗保健专业人员，医院外BLS认证的第一反应者（例如，EMT），以及 无证人员。在成功实现概念验证后，第二阶段将包括开发和 在设计控制下对BLS App进行设计验证测试，随后获得FDA 510（k）批准 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主要使命 用于改善心脏骤停质量的互连智能手表应用程序网络。我们的总体 一种假设是，救援人员和组织将通过以下方式提高他们的CPR质量，并最终提高生存率： 通过我们的交互式可穿戴技术实现持续质量改进系统。