Evaluating the utility of a prototype high acuity monitoring device for detecting deterioration in Covid-19 patients

2019冠状病毒病大流行是一场特殊的公共卫生危机；对世界各地的卫生保健系统构成巨大挑战，重症监护病房的能力面临不堪重负的危险。由于Covid-19影响呼吸，护士和医生必须能够发现相关生命体征的恶化，例如血氧或二氧化碳水平。这些生命体征是由几种设备记录的，这使得它们昂贵、耗时，而且容易出现人为错误。迫切需要一种能够减轻一线工作人员负担的设备。这个项目可以加快我们的设备和系统推向市场的进程，在这个比以往任何时候都更需要创新医疗设备的时代。我们的原型手持式便携式监护设备，Coremed，超便携，灵活，易于使用，用于捕获，传输和报告患者的生命体征。我们的设备记录并传输无创血压、脉搏、血氧、温度、呼吸和血管造影的读数，自动计算（修订）NEWS2评分，并在患者病情恶化时发出警报。数据显示，安全传输，不丢失。这可以最大限度地减少医疗、法律、道德和财务方面的影响。通过做所有这些事情，我们将使医生和护士能够更好地分析病人的信息。它将数据连续传输到Metix Remote，这是一个跟踪这些输出的远程监控系统，使它们在数字仪表板上对其他地方的临床工作人员可见。这使得对患者健康的监测更加有效，减少了临床错误，并提高了护理标准。测试我们的设备和系统的可用性将是无价的，并有利于我们的设备的最终营销。我们修订后的研究目标是：1)评估生命体征监测仪、其附件和用户文档，从而确定设备的UI设计优势和改进机会，特别关注Coremed a在使用过程中的安全性和有效性。2)根据未经培训的个体运用其临床知识和技能使用设备的能力，评估设备的整体直观性和可用性。3)评估Metix Remote；特别是看看它是否可靠地反映了在Coremed a上捕获的输出4)我们计划试点方法来比较记录和绘制生命体征所需的时间：为Coremed和类似的监视器设置，记录和绘制一整套生命体征所需的时间。5)探讨终端用户对我们的原型医疗器械和远程监控系统的看法。一旦获得研发批准，可用性测试将在格拉斯哥伊丽莎白女王大学医院（Queen Elizabeth University Hospital， QEUH）临床技能实验室进行。该项目将与NHS大格拉斯哥和克莱德一起进行。测试人员将对测试过程进行视频记录，并拍摄值得注意的用户交互，编译和分析测试数据和参与者的反馈，然后将测试结果记录在书面报告中。昆士兰卫生学院将提供：研究参与者（护士、医生、护理人员）；一个人体模型，和/或健康志愿者来连接设备，以及临床技能实验室。

The Covid-19 pandemic is an exceptional Public Health crisis; presenting an immense challenge to Healthcare systems around the world, with intensive care units capacity in danger of being overwhelmed. Because Covid-19 affects breathing, it is essential that Nurses and Doctors can detect deterioration in related vital signs, e.g. blood oxygen or carbon dioxide levels. These vital signs are recorded by several devices, making them costly, time-consuming, and prone to human error. A device that could ease the burden on front-line staff is sorely needed. This project can expedite the progress of our device and system to market, at a time when innovative medical devices are needed more than ever.Our prototype hand held portable monitor device, Coremed, is ultra-portable, flexible, easy to use, for capturing, transmitting and reporting patient vital signs. Our device records and transmits readings for non-invasive blood pressure, pulse, blood oxygen, temperature, respiration, and capnography, automatically calculates a (revised) NEWS2 score, and sounds an alert if the patient is in deterioration. Data is displayed, securely transferred and not lost. This can minimise medical, legal, ethical, and financial implications. By doing all of these things, we will enable Doctors and Nurses to better analyse information about patients.It transmits data continuously to Metix Remote, a remote monitoring system that tracks these outputs, making them visible on digital dashboards to clinical staff elsewhere. This makes monitoring of patient health more efficient, reducing clinical error, and improving standards of care.Testing the usability of our device and system will be invaluable, and benefit the eventual marketing of our device. Our revised study objectives are:1) To evaluate the vital signs monitor, its accessories and user documentation, thereby identifying the device’s UI design strengths and opportunities for improvement, with a particular focus on Coremed A’s safety and effectiveness during use.2) To evaluate the overall intuitiveness and usability of the device, based on the ability of untrained individuals to use the device with their clinical knowledge and skills.3) To evaluate Metix Remote; in particular to see if it reliably reflects the output captured on Coremed A.4) We plan to pilot methods for comparing time taken to record and chart vital signs: how long it takes to set up, record and chart a full set of vital signs for Coremed and a similar monitor.5) To explore the thoughts of end users about our prototype medical device and remote monitoring system. Usability testing will take place once R&D approval is given, at the Queen Elizabeth University Hospital (QEUH) clinical skills labs in Glasgow. This project will be conducted in conjunction with NHS Greater Glasgow & Clyde. Test personnel will video record the test sessions and photograph notable user interactions, compile and analyse the test data and participants' feedback, and then document the test findings in a written report. QEUH will provide: study participants (nurses, doctors, paramedics); a manikin, and/or healthy volunteers to attach the device to, and Clinical Skills Lab.