Temporary Pacing Safety Monitor - Digital Platform

临时起搏安全监视器 - 数字平台

• 批准号: 10051092
• 金额: $ 32.75万
• 依托单位: CARDIAC-TECH LTD
• 依托单位国家: 英国
• 项目类别: Collaborative R&D
• 财政年份: 2023
• 资助国家: 英国
• 起止时间: 2023 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=10051092
• 关键词: Temporary; Pacing; Safety; Monitor; Digital

Cardiac-Tech is a UK-based SME that is developing a novel safety monitoring system for temporary pacemakers which will lead to a higher standard of care.Many people are unaware that after open-heart surgery, patients often experience rhythm disturbances during their recovery which can lead to serious complications. Cardiac surgical patients are therefore normally fitted with a temporary pacing device after their procedure to ensure a near-normal rhythm is maintained.Unlike permanent (implanted) pacing systems, temporary pacemakers sit externally by the patient's bedside and are connected to the heart with wires that pass through the chest. The contact of these wires with the heart can degenerate from scar tissue formation or the patient's own movement; for example, when coughing.At present, temporary pacemakers are relatively unsophisticated and are unable to detect changes in the patient's parameters. They rely on periodic checks at the bedside, where dangerous changes can go unnoticed for hours. This can lead to overcompensation with medication that has unpleasant side effects and an extended recovery period. In the most extreme circumstances, inappropriate programming of the temporary pacemaker can lead the device to cause cardiac arrest.The U.S. Food and Drug Administration (FDA) holds a database on reported safety issues, where around 1,500 dangerous incidents related to temporary pacing are recorded yearly in the U.S. alone (_MAUDE website_). However, it is recognised that this number is potentially just 'the tip of the iceberg', as identifying the temporary pacemaker as the problem relies on expertise present at the time.To overcome these issues, Cardiac Tech Ltd. has developed a unique Temporary Pacing Safety Monitor (known as the Pace-Protect) that can analyse the pacemaker and patient's electrical signals and alert the relevant medical team whenever a problem with the pacemaker's programming is identified.In this project, Cardiac Tech Ltd. intends to work with two UK-based subcontractors, L2S2 Ltd and Control Developments (UK) Ltd., to develop a web platform and communications interface that will allow the remote monitoring of multiple networked Pace-Protect devices.The connection of Cardiac-Tech's pacemaker monitoring technology with a digital platform will allow alerts to be delivered to cardiologists and physiologists whenever pacing issues are identified and will ensure pacing expertise is on hand, wherever it is required.The system will reduce the opportunity for human error, ensure that patients in post-cardiac surgical care experience a safe and stable recovery and reduce stress levels for nursing staff.

Cardiac-Tech是一家总部位于英国的中小型企业，正在开发一种新型的临时心脏起搏器安全监测系统，这将导致更高的护理标准。许多人都不知道，在心脏直视手术后，患者在恢复期间经常会出现心律紊乱，这可能导致严重的并发症。因此，心脏手术患者通常在手术后安装临时起搏器，以确保维持接近正常的心律。与永久性（植入）起搏系统不同，临时起搏器位于患者床边的外部，并通过穿过胸部的导线与心脏连接。这些导线与心脏的接触可能会因疤痕组织的形成或患者自身的运动而退化;例如，当咳嗽时。目前，临时起搏器相对简单，无法检测到患者参数的变化。他们依赖于在床边的定期检查，在那里危险的变化可能会被忽视几个小时。这可能导致过度补偿与药物，有不愉快的副作用和延长恢复期。在最极端的情况下，临时起搏器的不当编程可能导致设备导致心脏骤停。美国食品和药物管理局（FDA）拥有一个关于报告安全问题的数据库，其中仅在美国每年就记录了大约1，500起与临时起搏器相关的危险事件（_MAUDE website_）。然而，人们认识到，这个数字可能只是“冰山一角”，因为识别临时起搏器的问题依赖于当时的专业知识。为了克服这些问题，Cardiac Tech Ltd.开发了一种独特的临时起搏安全监测器（称为Pace-Protect）分析起搏器和患者的电信号，并在发现起搏器编程出现问题时向相关医疗团队发出警报。在该项目中，Cardiac Tech Ltd.打算与两家英国分包商L2 S2 Ltd和Control Developments（UK）Ltd合作，开发一个网络平台和通信接口，允许远程监测多个联网的起搏保护设备。Cardiac-Tech的起搏器监测技术与数字平台的连接将允许在发现起搏问题时向心脏病学家和生理学家发送警报，并确保在需要时随时提供起搏专业知识。该系统将减少人为错误的机会，确保心脏手术后护理的患者经历安全和稳定的恢复，并减少护理人员的压力水平。