Wearable autonomous lactate monitoring device for improved management of sepsis patients

败血症和创伤是最困难、最耗费资源的紧急医疗事件之一。每年全球脓毒症病例约为3000万例，死亡人数超过600万。英国每年有250,000例败血症病例，46,000例死亡，造成156亿GB的损失(约克健康经济联合会)。美国每年的脓毒症成本为240亿美元，约为每位患者14,000美元(医疗研究和质量机构)。乳酸是用于监测败血症的生物标志物。脓毒症诊断市场目前价值3.7亿美元，CAGR(市场和市场)10%。持续监测和反应速度是改善临床结果的关键。超过第一个小时后，每延迟一小时的脓毒症治疗，死亡率增加4%，感染性休克增加8%。连续的乳酸监测指导尽可能早的干预，并通过乳酸清除率监测治疗反应，以降低治疗对患者出院的影响目前使用医院中心实验室或护理点血气分析仪来测量乳酸水平。这些“离线”设备需要反复的人工验血和护士的注意，可能会导致错过关键事件和延误治疗。连续乳酸盐监测溶液(MAQUET-EIRUS、SERBLE MEDICAL-PRIMA)过于昂贵、笨重且难以使用，阻碍了临床应用。电化学传感器(Probe Science--ContinuMon)和可穿戴设备(PK Vitality，Caura)正在开发中，但还没有接近市场，不太可能达到所需的准确性/精密度。尽管越来越多的证据支持生物标记物水平引导的脓毒症治疗，乳酸监测已经是临床指南的关键部分，临床医生仍然依赖手动采样和单点测量。为了更有效地应对败血症挑战，需要一种易于使用、准确、自主的乳酸监测仪。基于牛博士的研究(由EPSRC、NERC、MRC、ICURE和Innovate UK资助)，SouthWestSensor(SWS)正在开发一种紧凑型可穿戴乳酸监测设备来应对这一挑战。它将SWSS专利的纳米液滴技术与其专有的相移泵送方法相结合，以自主提取样本(血清或间质液体)并运行微型湿化学分析进行定量。该项目将研究脓毒症治疗的临床和商业驱动因素，分析医疗保健经济学，开发工作原型，并与组成该项目临床咨询委员会的关键临床医生进行测试。此外，每年还将挽救多达14,000人的生命。并将NHS成本降低约11亿GB，将产生更广泛的社会、地区和环境效益。

Sepsis and trauma are among the most difficult, resource-intensive medical emergencies. Annual global sepsis cases are ~ 30m, with 6+m fatalities. UK has 250,000 sepsis cases annually with 46,000 deaths, costing £15.6 billion (York Health Economics Consortium). Annual US sepsis costs are $24bn, ~$14,000 per patient (Agency for Healthcare Research and Quality). Lactate is the biomarker used to monitor sepsis. The sepsis diagnostics market is currently $370m with 10% CAGR (MarketsandMarkets).Continuous monitoring and speed of response are critical in improving clinical outcomes. Beyond first hour, every additional hour of delayed sepsis treatment increases mortality by 4% with septic shock 8%. Continuous lactate monitoring guides earliest possible intervention and monitoring treatment response with lactate clearance rate informs de-escalation of treatment towards patient dischargeLactate levels are currently measured using hospital central labs or point-of-care blood gas analysers. These 'offline' devices require repeated manual blood tests and nurses' attention, resulting in potentially missed critical events and delayed treatment. Continuous lactate monitoring solutions (Maquet - Eirus, Sphere Medical - Proxima) are too expensive, bulky and difficult to use, hampering clinical uptake. Electrochemical sensors (Probe Scientific -- ContinuMon) and wearables (PK Vitality, Caura) are under development but not near-market and unlikely to meet required accuracy/precision.Despite mounting evidence supporting biomarker-level guided sepsis management, and lactate monitoring already a key part of clinical guidelines, clinicians still rely on manual sampling and single-point measurements. An easy-to-use, accurate, autonomous lactate monitor is needed to tackle the sepsis challenge more effectively.Based on Dr Niu's research (funded by EPSRC, NERC, MRC, ICURe, and Innovate UK) SouthWestSensor (SWS) is developing a compact wearable lactate monitoring device to address this challenge. It combines SWSs' patented nano-droplet technology with its proprietary phase-shifted pumping approach to autonomously draw samples (serum or interstitial fluid) and run miniaturised wet chemical assays for quantitation.The project will research clinical and business drivers in the treatment of sepsis, analyze healthcare economics, develop a working prototype, and test this with key clinicians who form the Clinical Advisory board for the project.In addition to saving up to 14,000 lives p.a. and reducing NHS costs by ~£1.1bn, there will be wider social, regional and environmental benefits.