Temporary Pacing Safety Monitor - Digital Platform
Temporary Pacing Safety Monitor - Digital Platform
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 --
中文摘要
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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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