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

• 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
• 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; 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

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中规定的药物，阿片类药物诱发的呼吸道 抑郁症（OIRD）是一个宽度和威胁生命的问题。综合医院地板上的oird情节 很常见，最多发生在46％的患者中。尽管这个问题流行了，但Oird尚未 通过监视技术有效解决。对可穿戴传感器的临床需求很大 在严重发作之前，以可操作的警报检测Oird的发作和进展 衰减不足，低氧血症，心律不齐和死亡。为了满足这种临床需求，RTM生命体征，LLC是 开发带有声气管的可穿戴，无线呼吸监测系统（RMS） 传感器（TSS）和软件算法不断测量一个人的呼吸率（RR），潮汐 体积（电视），微小通风（MV），呼吸模式，呼吸暂停持续时间，氧饱和度，程度 打nor，心率（HR），身体位置和活动水平。 RMS算法计算风险指数分数 （RIS）专门每20秒钟。 RTM已收到FDA的突破设备名称 开发预防住院患者，门诊病人和 长期使用或滥用阿片类药物的美国公民。 RTM计划首先将RMS商业化以进行监视 由于OIRD的高事件，住院的患者在一般护理地板上治疗了阿片类药物 这些环境以及使用现有方法的不切实际性，例如脉搏血氧饱和度结合 二次摄影可为所有接受阿片类药物的患者提供足够的监测。已经证明了 我们技术的可行性，我们正在努力优化RMS来处理噪声环境并验证 临床研究中的系统。在第1阶段，我们将通过动态过滤和主动噪声优化现有的RMS 取消软件（第1阶段，目标1），并使用优化的RMS进行人类研究以测量 噪声环境中RR，TV和呼吸暂停持续时间的准确性，并通过过滤/噪声取消软件 打开，对关闭（第1阶段，AIM 2）。在第2阶段，我们将构建和基准测试功能RMS先验 进行人类临床试验（第2阶段，AIM 1），获得FDA研究设备豁免（IDE），然后获得 对芬太尼和其他阿片类药物管理的术后手术患者进行观察性临床试验 为了证明RMS检测和预测OIRD事件的发作和进展的能力（n = 120名患者） （第2阶段，目标2）。这些步骤将共同完成所需的关键发展里程碑和临床测试 用于RMS设备的监管批准和商业化。成功完成该项目将 生产商业可行的可穿戴无线RMS，有可能改善健康和安全性 通过准确检测和预测Oird的患者在 严重缺乏症，低氧血症，心律不齐和死亡的发作。