Advanced Prediction of Emerging Respiratory Decline with the Linshom Continuous Predictive Respiratory Sensor (CPRS)

摘要： 这一Fast-Track SBIR应用程序将资助并启用一种新的呼吸监测方法，即连续 预测性呼吸监测(CPRM)，可降低呼吸系统疾病的发病率和死亡率 妥协，同时降低医疗保健系统的成本。当前的设备和系统(人和机器) 呼吸监测的反应是当患者达到阈值时发出警告警报 生理参数(即SpO2、EtCO2)和患者目前或曾经处于危难中。工艺性 局限性阻碍了该领域在预测患者下降方面的进一步发展，从而使健康 护理提供者(HCP)能够进行干预，阻止或纠正呼吸下降。林顺已经开发出一种 简单、廉价的解决方案，用于持续监测呼吸功能，包括RR、TV、MV、I/E比率、 以及呼吸暂停检测。林顺510k获得FDA批准的连续预测性呼吸传感器(CPRS)解决方案 使用小型、便携、廉价的传感器和监视器来跟踪上述未满足的现有需求 RR、TV、MV、自上次呼吸以来的秒数(SSLB)和实时I/E比。这些参数对于 监测患有急性和慢性呼吸道疾病的患者。与其他呼吸道不同 在监控技术方面，Linshm在患者床边提供了手术室质量的呼吸配置文件， 这使医疗保健提供者能够迅速诊断新出现的呼吸衰退并干预 适当的医疗护理。及时的干预应减少发病率和死亡率，并显著 改善对病人的护理，并通过减少快速反应为医疗保健系统节省大量资金 激活和ICU转院。林顺为非插管患者提供电视(从而MV)的独特能力 创建以前在手术室或ICU之外无法获得的患者呼吸状态的配置文件(并且仅限于 插管病人)。 在此快速跟踪SBIR中，我们将：i)生成临床数据，证明Linsham CPRM检测(预测) 在目前的护理和设备标准之前，呼吸抑制发作(RDE)，2)确定最佳时间 设置早期警报(最大限度地提高敏感度和特异度)，以便HCP能够更早地干预 目前的做法，避免因呼吸衰竭而导致的发病率和死亡率，以及四.)将CPR重新设计为 基于微型芯片的设备，通过启用鼻插管使Linshm CPRM能够接触到更多的患者 (最终是家庭监视器)集成。

Abstract: This Fast-track SBIR application will fund and enable a new approach to respiratory monitoring, continuous predictive respiratory monitoring (CPRM), that stands to reduce morbidity and mortality due to respiratory compromise, while reducing health care system costs. Current devices and systems (human and machine) for respiratory monitoring are responsive by sounding a warning alarm when a patient reaches a threshold of a physiologic parameter (i.e. SpO2, ETCO2) and the patient is currently or has been in distress. Technological limitations have prevented the field from moving further in its ability to predict patient decline so that health care providers (HCPs) are able to intervene and stop or correct respiratory decline. Linshom has developed a simple, inexpensive solution for continuous monitoring of respiratory functions including RR, TV, MV, I:E ratio, and apnea detection. Linshom's 510k FDA-cleared Continuous Predictive Respiratory Sensor (CPRS) solves existing unmet needs mentioned above with a small, portable, and inexpensive sensor and monitor that tracks RR, TV, MV, seconds since last breath (SSLB), and I:E ratio in real time. These parameters are crucial for monitoring of patients suffering from both acute and chronic respiratory illness. Unlike other respiratory monitoring technologies, Linshom offers an operating room-quality respiratory profile at the patient bedside, which allows health care providers to promptly diagnose emerging respiratory decline and intervene with appropriate medical care. Timely intervention should reduce morbidity and mortality and result in significantly improved care for the patient and large savings for the health care system via reduction in rapid response activation and ICU transfers. Linshom’s unique ability to provide TV (and thus MV) in the non-intubated patient creates a profile of patient respiratory status previously not available outside of the OR or ICU (and only in intubated patients). In this Fasttrack SBIR we will i) Generate clinical data proving Linshom CPRM’s ability to detect (predict) a respiratory depression episode (RDE) before current standard of care and devices, ii.) Determine optimal times to set early warning alarms (maximizing sensitivity and specificity) such that HCPs can intervene sooner than current practice and avoid morbidity and mortality due to respiratory failure, and iv.) Redesign the CPRS into a miniaturized chip based device enabling the Linshom CPRM to reach more patients by enabling nasal cannula (and eventually a home monitor) integration.