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

可穿戴无线呼吸监测系统，可检测和预测阿片类药物引起的呼吸抑制

基本信息

批准号：
10784983
负责人：
Magdalena Kirlakovsky Bosak
金额：
$ 32.56万
依托单位：
RTM VITAL SIGNS, LLC
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-09-15 至 2024-09-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10784983
关键词：
3D Print Acoustics Address Adult Adverse event Air Movements Algorithmic Software Algorithms Anesthesia procedures Apnea Arrhythmia Bluetooth Breakthrough device Breathing Calibration Capnography Caring Cessation of life Chronic Clinical Clinical Research Clinical Trials Computer software Computers Data Development Devices Diagnostic Discipline of Nursing Drug Prescriptions Engineering Environment Event Fentanyl Floor Future General Hospitals Health Heart Rate High Prevalence Hospitalization Hospitals Hour Human Hypoventilation Hypoxemia Incidence Inhalation Life Measurement Measures Methods Monitor Nature Noise Operative Surgical Procedures Opioid Outpatients Oxygen Patient-Focused Outcomes Patients Pattern Performance Persons Phase Physiologic pulse Postoperative Period Prevalence Prevention Pulse Oximetry Risk Safety Sensitivity and Specificity Signal Transduction Skin Snoring Software Design Step Tests System Technology Testing Tidal Volume Titrations Trachea Update Ventilator Ventilatory Depression Work body position cloud platform commercialization data exchange detection platform flexibility human study improved indexing laptop novel opioid abuse opioid mortality opioid overdose patient safety rate of change research clinical testing respiratory sensor sound success trend ventilation volunteer wearable sensor technology wireless wireless sensor

项目摘要

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.

项目摘要。阿片类药物是美国医院最常使用的药物，并且阿片类药物会引起呼吸道疾病。抑郁症 (OIRD) 是综合医院中普遍存在且危及生命的问题。这种情况很常见，发生率高达 46%，尽管该问题普遍存在，但 OIRD 尚未得到解决。通过监测技术有效地解决了临床对可穿戴传感器的巨大需求。早在严重疾病发作之前就通过可操作的警报检测 OIRD 的发作和进展为了满足这一临床需求，RTM Vital Signs, LLC 致力于预防通气不足、低氧血症、心律失常和死亡。开发具有气管声学功能的可穿戴无线呼吸监测系统 (RMS) 传感器 (TSS) 和软件算法可连续测量人的呼吸频率 (RR)、潮汐容量 (TV)、每分钟通气量 (MV)、呼吸模式、呼吸暂停持续时间、氧饱和度、呼吸暂停程度打鼾、心率 (HR)、身体位置和活动水平 RMS 算法计算风险指数分数。 (RIS) 专门针对 OIRD 每 20 秒 RTM 已获得 FDA 突破性设备称号。开发 RMS 以预防住院患者、门诊患者和患者中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计划首先将 RMS 商业化，用于监测。由于 OIRD 发病率高，住院患者在普通护理楼层接受阿片类药物治疗这些环境以及使用现有方法（例如脉搏血氧饱和度测定法）的不切实际性二氧化碳图可为所有接受阿片类药物的患者提供充分的监测。我们的技术的可行性，我们正在努力优化 RMS 以处理嘈杂的环境并验证在第一阶段的临床研究中，我们将通过动态滤波和有源噪声来优化现有的 RMS。消除软件（第 1 阶段，目标 1）并使用优化的 RMS 进行人体研究来测量使用过滤/噪声消除软件在嘈杂环境中测量 RR、TV 和呼吸暂停持续时间的准确性打开与关闭（第 1 阶段，目标 2）。在第 2 阶段，我们将事先构建并测试功能 RMS。进行人体临床试验（第 2 阶段，目标 1），获得 FDA 研究设备豁免 (IDE)，然后对接受芬太尼和其他阿片类药物治疗的术后患者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 名患者）（第 2 阶段，目标 2）。这些步骤将共同实现关键的开发里程碑和所需的临床测试。 RMS 设备的监管批准和商业化将成功完成。生产商业上可行的可穿戴无线 RMS，有可能改善健康和安全通过在治疗前准确检测和预测 OIRD 以及可操作的警报，减少接受阿片类药物治疗的患者出现严重通气不足、低氧血症、心律失常和死亡。