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

使用 Linshom 连续预测呼吸传感器 (CPRS) 对新出现的呼吸衰退进行高级预测

• 批准号: 10546880
• 负责人: Ronen Feldman
• 金额: $ 36.08万
• 依托单位: LINSHOM MEDICAL INC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-21 至 2023-09-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10546880
• 关键词: Accident and Emergency department; Acute; Adoption; Adverse event; Apnea; Cannulas; Capnography; Caring; Chronic; Clinical; Clinical Data; Clinical Research; Complex; Data; Data Set; Detection; Development; Devices; Diagnosis; Discipline of Nursing; Distress; Early Diagnosis; Engineering; Enrollment; Event; Fibrinogen; Floor; Funding; Future; Goals; Gold; Growth; Health Personnel; Healthcare; Healthcare Systems; Home; Hour; Human; Intensive Care Units; Intervention; Measurement; Measures; Medical; Methods; Monitor; Morbidity - disease rate; Nose; Operating Rooms; Outcome; Oxygen saturation measurement; Patient Care; Patient Monitoring; Patients; Phase; Physiologic pulse; Physiological; Postoperative Period; Process; Production; Pulse Oximetry; Research; Respiration; Respiratory Failure; Respiratory physiology; Savings; Seminal; Sensitivity and Specificity; Small Business Innovation Research Grant; Statistical Data Interpretation; System; Technology; Temperature; Testing; Tidal Volume; Time; Ventilatory Depression; base; commercialization; cost; design; improved; innovation; miniaturize; miniaturized sensor; mortality; novel; novel strategies; portability; preempt; prevent; profiles in patients; prototype; quality assurance; research and development; respiratory; response; sensor; sensor technology; sound; standard of care; tool; tool development; ventilation; verification and validation

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.

摘要： 这种快速通道SBIR应用程序将资助并实现呼吸监测的新方法， 预测性呼吸监测（CPRM），可以降低呼吸道疾病引起的发病率和死亡率。 在降低医疗保健成本的同时，目前的设备和系统（人和机器）， 呼吸监测通过在患者达到呼吸阈值时发出警告警报来响应。 生理参数（即SpO2、ETCO2），并且患者目前或曾经处于痛苦之中。技术 局限性阻碍了该领域在预测患者衰退的能力方面取得进一步进展， 护理提供者（HCP）能够干预并停止或纠正呼吸下降。Linshom开发了一种 用于连续监测呼吸功能的简单、廉价的解决方案，包括RR、TV、MV、I：E比率， 和呼吸暂停检测。Linshom的510k FDA批准的连续预测呼吸传感器（CPRS）解决了 现有的未满足的需求，上面提到的一个小，便携式和廉价的传感器和监视器，跟踪 RR、TV、MV、自上次呼吸后的秒数（SSLB）和真实的I：E比。这些参数对于 监测患有急性和慢性呼吸道疾病的病人。与其他呼吸系统不同， 监测技术，Linshom在患者床边提供手术室质量的呼吸曲线， 这使得卫生保健提供者能够及时诊断新出现的呼吸衰竭， 适当的医疗护理。及时的干预可以降低发病率和死亡率， 通过减少快速反应，改善对患者的护理，并为医疗保健系统节省大量资金 激活和ICU转移。Linshom在非插管患者中提供TV（以及MV）的独特能力 创建以前在OR或ICU外部不可用的患者呼吸状态的配置文件（并且仅在 插管患者）。 在此Fasttrack SBIR中，我们将i）生成临床数据，证明Linshom CPRM检测（预测） 在当前护理标准和设备之前的呼吸抑制发作（RDE），ii.）确定最佳时间 设置早期预警警报（最大限度地提高灵敏度和特异性），以便HCP能够在 目前的做法，并避免由于呼吸衰竭的发病率和死亡率，和iv.）将CPRS重新设计为 基于微型芯片的设备，使Linshom CPRM能够通过使鼻插管到达更多患者 (and最终是家庭监视器）集成。