Development of a paper-based sensor for continuous breath analysis for monitoring patient health

呼吸频率被描述为患者病情恶化的最敏感的单一指标（NICE, 2017）。然而，在普通病房，呼吸频率只能通过视觉评估来监测（从远处观察病人并计算胸部的升降），每12小时30秒。除了耗时、定性和极易出现人为错误外，一些引人注目的案例强调，败血症病例中缺失的观察结果导致了可避免的患者死亡，包括婴儿（PHSO, 2013）。败血症是一种危及生命的疾病，每年在英国造成5.2万人死亡（英国败血症信托基金会，2018年），仅次于心血管疾病。败血症幸存者通常会遭受长期的精神和身体影响，包括截肢、器官衰竭、慢性疼痛、疲劳和创伤后应激障碍（NHS England, 2015）。在全球范围内，该疾病每年夺去600万人的生命，包括100万新生儿和10万孕产妇死亡（世卫组织，2017年）。脓毒症治疗每延迟1小时，患者的死亡风险增加7.6% (Kumar et al., 2006)，这意味着到下一次观察时，脓毒症患者的死亡机会可能增加到50%。然而，如果及早发现，败血症是一种高度可治疗的疾病。估计表明，在英国，早期识别和治疗败血症每年可以挽救1.4万人的生命，并避免40万个住院日，可能为经济节省28亿英镑（YHEC, 2017）。在Innovate UK的资助下，Spyras将开发一种经济实惠的一次性可穿戴医疗设备，用于普通病房的连续实时呼吸分析。我们的联网设备有可能自动提醒临床医生注意出现早期恶化迹象的患者。与市场上已有的竞争设备相比，我们的纸质传感器成本更低，更准确。我们将在健康受试者中演示设备性能，为项目后临床试验做好准备。由于英国医院对败血症的诊断和治疗较晚，59000名患者从术后和产后病房进入重症监护病房，NHS的直接治疗费用为1.88亿英镑；12,000人在入院期间死亡，而19,400人在30天内再次住院，并出现长期败血症后并发症（Norman et al., 2017）。在英国，仅在这个应用中使用我们的设备每年就可以挽救5250人的生命。

Breathing rate has been described as the single most sensitive marker of patient deterioration (NICE, 2017). Yet, in general wards, breathing rate is only monitored through visual assessment (observing the patient from a distance and counting the rising and falling of the chest) for 30 seconds every 12 hours. As well as being time-consuming, qualitative, and highly prone to human error, several high-profile cases have highlighted that missing observations in sepsis cases have led to avoidable patient death, including babies (PHSO, 2013).Sepsis is a life-threatening condition responsible for 52,000 deaths in the UK annually (UK Sepsis Trust, 2018), second only to cardiovascular disease. Sepsis survivors often suffer from long-term mental and physical effects, including amputations, organ failure, chronic pain, fatigue and post-traumatic stress disorder (NHS England, 2015). Globally, the disease claims 6 million lives a year, including 1 million newborn babies and 100,000 maternal deaths (WHO, 2017).For every hour's delay in the treatment of sepsis, the patient's risk of death increases by 7.6% (Kumar et al., 2006), meaning that by the next observation a sepsis patient's chance of death may have increased to 50%. Yet, sepsis is a highly treatable condition if detected early. Estimates indicate that earlier identification and treatment of sepsis across the UK could save 14,000 lives annually, as well as avoid 400,000 hospital bed days, potentially saving the economy £2.8 billion (YHEC, 2017).With funding from Innovate UK, Spyras will develop an affordable, disposable wearable medical device for continuous real-time breathing analysis in general wards. Our connected device has the potential to automatically alert clinicians to patients showing early signs of deterioration. Compared to competitive devices already on the market, our paper-based sensor is lower cost and more accurate. We will demonstrate device performance in healthy subjects, ready for post-project clinical trials.As a result of late diagnosis and treatment of sepsis in UK hospitals, 59,000 patients enter intensive care units from post-operative and post-natal wards, at a direct treatment cost to the NHS of £188 million; 12,000 die during this first period of admission, while 19,400 are rehospitalised within 30 days and have long-term post-sepsis complications (Norman et al., 2017). The use of our device solely in this application could save 5,250 lives annually in the UK.