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73,784
2020-06-01 to 2021-03-31
Feasibility Studies
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.