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Temporary Pacing Safety Monitor - Digital Platform

Temporary Pacing Safety Monitor - Digital Platform
临时起搏安全监视器 - 数字平台
批准号:
10051092
负责人:
金额:
$32.75万
依托单位:
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
项目状态:
已结题
起止时间:
2023 至 --

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中文摘要
翻译
心脏科技是一家总部位于英国的中小企业,该公司正在为临时起搏器开发一种新的安全监测系统,这将导致更高的护理标准。许多人没有意识到,心脏直视手术后,患者在康复过程中经常经历心律失常,这可能会导致严重的并发症。因此,心脏外科患者在手术后通常会安装临时起搏器,以确保保持接近正常的心律。与永久性(植入式)起搏系统不同,临时起搏器位于患者床边的外部,并通过穿过胸部的电线连接到心脏。这些电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。他们依赖于床边的定期检查,在那里危险的变化可能会几个小时都不被注意到。这可能会导致药物过度补偿,产生令人不快的副作用,并延长恢复期。在最极端的情况下,临时起搏器的不当编程可能会导致心脏骤停。美国食品和药物管理局(FDA)拥有一个报告的安全问题数据库,其中仅在美国每年就记录了大约1500起与临时起搏器有关的危险事件(_Maude网站_)。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,心脏技术有限公司开发了一种独特的临时起搏安全监测器(称为起搏保护),它可以分析起搏器和患者的电信号,并在发现起搏器的编程问题时向相关医疗团队发出警报。在这个项目中,心脏技术有限公司打算与两家总部位于英国的分包商L2S2有限公司和Control Developments(UK)有限公司合作。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。心脏技术公司的起搏器监测技术与数字平台的连接将使心脏起搏器监测技术能够在发现起搏问题时向心脏病医生和生理学家发送警报,并确保起搏专业知识随时随地随时随地提供。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安全稳定地康复,并减轻护理人员的压力水平。
英文摘要
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.
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