Feasibility of diagnosing cardio-respiratory conditions by advanced analysis of parameters in Tidal Breathing CO2 Waveforms

位于剑桥郡Swavesey的剑桥呼吸创新有限公司（CRiL）已获得Innovate UK的资助，以完成一项针对慢性呼吸疾病的创新诊断设备的可行性研究。目前，临床医生需要使用一系列医疗设备，从峰值流量计到肺活量计和脉搏血氧仪，再到扫描和x射线，来诊断呼吸系统疾病。诊断哮喘、慢性阻塞性肺病和其他慢性呼吸系统疾病最常用的设备是肺活量计和峰值流量计。这两种设备对患者来说都很难使用，依赖于用力呼气操作，依赖于技术和测量呼吸代理。呼吸窘迫的成年人和儿童不能使用这些设备。CRiL开发了一种创新的外延生长III-V led二氧化碳传感器，比任何现有的白炽灯或荧光灯二氧化碳传感器更快，更准确，更一致。它不受呼吸中的冷凝影响，而且是成本的一小部分。我们专门开发了它来测量正常潮汐呼吸中的二氧化碳波形形状，用于低成本的个人呼吸监测仪。潮汐呼吸CO2 （TBCO2）波形形状分析是一种已建立但未充分利用的呼吸条件生物标志物。虽然测量呼出二氧化碳的医疗设备（称为二氧化碳计）在手术室中很常见，但测量潮汐呼吸二氧化碳的设备目前还没有用于任何形式的呼吸系统疾病诊断。本可行性研究将完成研究，建立利用CRiL平台硬件在手术、医生办公室或诊所捕获TBCO2波形形状，并利用波形形状中的参数诊断特定呼吸疾病的可行性。它将包括研究临床医生的需求，并将提供一个“概念验证”设备，以继续这项技术的发展。主要关注的领域将是用户的需求、设计投入以及技术和数据集的潜力。这项可行性研究的主要成果将是全部计算费用的发展计划。这项可行性研究将确定是否存在任何技术障碍，阻碍基于潮汐呼吸二氧化碳测量的呼吸诊断设备的发展，医学界是否会支持这种设备，医生可能需要哪些证据和教育来支持它，以及是否存在任何知识产权机会和障碍。”

"Cambridge Respiratory Innovations Limited (CRiL), of Swavesey, Cambridgeshire, has been awarded a grant by Innovate UK to complete a feasibility study into an innovative new diagnostic device for chronic respiratory conditions.Currently a clinician needs to use a range of medical devices, from peak-flow meters through spirometers and pulse oximeters to scans and x-rays, to diagnose a respiratory condition. The most commonly used devices to diagnose asthma, COPD and other chronic respiratory diseases are spirometers and peak-flow meters. Both devices are difficult for patients to use, rely on forced expiratory manoeuvres, are technique dependent and measure a respiratory proxy. Adults in respiratory distress and children cannot use these devices.CRiL has developed an innovative epitaxially-grown III-V LED-based CO2 sensor which is faster, more accurate and more consistent than any existing incandescent or florescent CO2 sensor. It is not affected by condensation in the breath and is a fraction of the cost. We have developed it specifically to measure the CO2 waveform shape in normal tidal breathing to use in low-cost personal respiratory monitors. Tidal breathing CO2 (TBCO2) waveform shape analysis is an established but under-used biomarker for respiratory conditions. Whilst medical devices that measure exhaled CO2 (called capnometers) are commonplace in the operating theatre, devices that measure tidal breathing CO2 are not used in any form of respiratory disease diagnosis at the moment.This feasibility study will complete research to establish the feasibility of using CRiL's platform hardware to capture the TBCO2 waveform shape in the surgery, doctors office or clinic and use the parameters in the waveform shape to diagnose specific respiratory conditions. It will include researching the needs of the clinicians and will deliver a ""proof of concept"" device to continue the development of the technology. The main areas of focus will be the users' needs, the design inputs and the potential of the technology and dataset. The primary output from this feasibility study will be the fully-costed development plan.This feasibility study will identify whether there are any technical impediments which prevent the development of a respiratory diagnostic device based on tidal breathing CO2 measurement, whether the medical profession would support such a device, what evidence and education doctors might require to support it and whether there are any intellectual property opportunities and hurdles."