Temporary Pacing Safety Monitor - Caseworks and User Interface

临时起搏安全监视器 - 案例和用户界面

• 批准号: 10042881
• 金额: $ 5.22万
• 依托单位: CARDIAC-TECH LTD
• 依托单位国家: 英国
• 项目类别: Grant for R&D
• 财政年份: 2022
• 资助国家: 英国
• 起止时间: 2022 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=10042881
• 关键词: Temporary; Pacing; Safety; Monitor; Caseworks

Many people are unaware that after open-heart surgery, patients often experience rhythm disturbances during recovery which can lead to serious complications. Cardiac surgical patients are therefore normally fitted with a temporary pacing system after their procedure to ensure a near-normal rhythm is maintained.Unlike permanent (implanted) pacing systems, temporary pacemakers sit externally at 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 often 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, where dangerous changes can go unnoticed for hours. The associated issues and mis-identification of cause can lead to overcompensation with medication that has unpleasant side-effects and is associated with an extended recovery period. In the most extreme circumstances, inappropriate programming of the temporary pacemaker can lead the device to cause cardiac arrest.The FDA holds a database (MAUDE) on reported safety issues, where around 1,500 dangerous incidents related to temporary pacing are recorded yearly in the US alone, and this is potentially just the tip of the iceberg - since identifying the temporary pacemaker as the problem relies on expertise present at the time. Cardiac Tech have polled over 100 cardiologists, cardiac physiologists and nurses in the U.K. and 75% either agree or strongly agree that there are serious safety issues in temporary pacing.To overcome these issues, Cardiac Tech is developing a unique temporary pacing safety device that will monitor the pacemaker and patient's electrical signals and timings. The device uses sophisticated software to instantly alert medical staff to dangerous changes in pacing function in order to make sure that patients get the best treatment and the correct medication and can be discharged sooner. The device will reduce the opportunity for human error and ensure that patients in post-cardiac surgical care experience a safe and stable period of recovery.Cardiac Tech have built a fully functioning prototype of their device that proves the technology works. In this project, the company plans to work with an award winning design consultancy to develop a bespoke ergonomic casing and intuitive user interface that will allow surgeons, doctors and nursing staff to easily fit the device to current pacemakers and monitor their patients 24/7 in the clinical environment.

许多人不知道，在心内直视手术后，患者在恢复过程中经常会出现心律失常，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系统，以确保维持接近正常的心律。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，通过穿过胸部的电线与心脏相连。这些导线与心脏的接触通常会因疤痕组织形成或患者自身运动而退化；比如，咳嗽的时候。目前，临时起搏器相对简单，无法检测患者参数的变化。它们依赖于定期检查，危险的变化可能几个小时都不会被注意到。相关的问题和错误的原因识别可能导致药物过度补偿，这有令人不快的副作用，并与延长的恢复期有关。在最极端的情况下，临时起搏器的不当编程可能导致该装置引起心脏骤停。FDA拥有一个报告安全问题的数据库（MAUDE），仅在美国每年就记录了大约1500起与临时起搏器相关的危险事件，这可能只是冰山一角——因为确定临时起搏器是问题依赖于当时的专业知识。Cardiac Tech对英国100多名心脏病专家、心脏生理学家和护士进行了调查，75%的人同意或强烈同意临时起搏存在严重的安全问题。为了克服这些问题，Cardiac Tech正在开发一种独特的临时起搏安全装置，该装置将监测起搏器和患者的电信号和时间。该设备使用复杂的软件，在起搏功能发生危险变化时立即提醒医务人员，以确保患者得到最好的治疗和正确的药物，并能早日出院。该设备将减少人为失误的机会，并确保心脏手术后护理的患者经历一个安全稳定的恢复期。心脏科技公司已经建立了一个功能齐全的设备原型，证明这项技术是可行的。在这个项目中，该公司计划与一家屡获殊荣的设计咨询公司合作，开发定制的符合人体工程学的外壳和直观的用户界面，使外科医生、医生和护理人员能够轻松地将该设备安装到当前的起搏器上，并在临床环境中全天候监测患者。