Wearable Wireless Respiratory Monitoring System that Detects and Predicts Opioid Induced Respiratory Depression

项目摘要。阿片类药物是美国医院最常用的处方药，阿片类药物引起的呼吸道疾病 抑郁症（OIRD）是一种广泛存在且威胁生命的问题。OIRD在综合医院楼层的发作 常见于46%的患者。尽管这一问题普遍存在，但OIRD尚未 通过监测技术有效解决。临床上非常需要一种能够 检测OIRD的发作和进展，并发出可采取行动的警报， 换气不足、低氧血症、心律失常和死亡。为了满足这一临床需求，RTM Vital Signs，LLC 开发具有声学气管声音的可穿戴无线呼吸监测系统（RMS） 传感器（TSS）和软件算法，其连续测量人的呼吸率（RR）、潮气量（tidal 通气量（TV）、每分钟通气量（MV）、呼吸模式、呼吸暂停持续时间、氧饱和度、 打鼾、心率（HR）、身体姿势和活动水平。RMS算法计算风险指数分数 (RIS)特别是OIRD的RTM已获得FDA的突破性器械认定 开发RMS，用于预防住院患者、门诊患者的阿片类药物过量和死亡， 长期使用或滥用阿片类药物的美国公民。RTM计划首先将RMS商业化用于监测 由于OIRD的高发病率， 这些环境和使用现有方法的不切实际性， 二氧化碳监测，为所有接受阿片类药物的患者提供充分的监测。已经证明了 我们的技术的可行性，我们正在努力优化RMS处理嘈杂的环境，并验证 系统在临床研究中。在第1阶段，我们将通过动态滤波和有源噪声优化现有RMS 消除软件（第1阶段，目标1），并使用优化的RMS进行人体研究，以测量 使用滤波/噪声消除软件在噪声环境中测量RR、TV和呼吸暂停持续时间的准确性 打开与关闭（阶段1，目标2）。在第2阶段，我们将构建和台架测试功能RMS之前， 人体临床试验（2期，目标1），获得FDA研究器械豁免（IDE），然后 在使用芬太尼和其他阿片类药物治疗的术后手术患者中进行观察性临床试验 证明RMS检测和预测OIRD事件发生和进展的能力（n = 120例患者） （第二阶段，目标2）。这些步骤将共同完成关键的开发里程碑和所需的临床试验 用于RMS设备的监管批准和商业化。该项目的成功完成将 生产商业上可行的可穿戴无线RMS，具有改善健康和安全的潜力 通过准确检测和预测OIRD并在治疗前发出可操作警报， 出现严重换气不足、低氧血症、心律失常和死亡。

PROJECT SUMMARY. Opioids are the most prescribed drug in US hospitals, and opioid induced respiratory depression (OIRD) is a widespread and life-threatening problem. Episodes of OIRD on the general hospital floor are common, occurring in up to 46% of patients. Despite the prevalence of this problem, OIRD has yet to be effectively addressed through monitoring technology. There is great clinical need for a wearable sensor capable of detecting the onset and progression of OIRD with actionable alerts, well before the onset of severe hypoventilation, hypoxemia, cardiac arrhythmia, and death. To meet this clinical need, RTM Vital Signs, LLC is developing a wearable, wireless Respiratory Monitoring System (RMS) with an acoustic Trachea Sound Sensor (TSS) and a software algorithm that continuously measures a person’s respiratory rate (RR), tidal volume (TV), minute ventilation (MV), breathing pattern, duration of apnea, oxygen saturation, degree of snoring, heart rate (HR), body position, and activity level. The RMS algorithm calculates a Risk Index Score (RIS) specifically for OIRD every 20 seconds. RTM has received Breakthrough Device Designation from the FDA to develop the RMS for the prevention of an opioid overdose and death in hospitalized patients, outpatients, and US citizens that chronically use or abuse opioids. RTM plans to commercialize the RMS first for monitoring hospitalized patients managed with opioids on the general nursing floors, due to the high incidence of OIRD in these environments and the impracticality of using existing methods such as pulse oximetry combined with capnography to provide sufficient monitoring for all patients receiving opioids. Having already demonstrated feasibility of our technology, we are working to optimize the RMS to handle noisy environments and validate the system in a clinical study. In Phase 1, we will optimize the existing RMS with dynamic filtering and active noise cancellation software (Phase 1, Aim 1) and conduct a human study using the optimized RMS to measure the accuracy of RR, TV, and apnea duration in a noisy environment with the filtering/noise cancellation software turned on, versus turned off (Phase 1, Aim 2). In Phase 2, we will construct and bench-test functional RMS prior to a human clinical trial (Phase 2, Aim 1), obtain an FDA Investigational Device Exemption (IDE), and then conduct an observational clinical trial in post-operative surgical patients managed with fentanyl and other opioids to demonstrate RMS’s ability to detect and predict the onset and progression of an OIRD event (n = 120 patients) (Phase 2, Aim 2). Together, these steps will accomplish key development milestones and clinical testing needed for regulatory approval and commercialization of the RMS device. Successful completion of this project will produce a commercially viable wearable wireless RMS with the potential to improve the health and safety of patients receiving opioids by accurately detecting and predicting OIRD with actionable alerts prior to the onset of severe hypoventilation, hypoxemia, cardiac arrhythmia, and death.