Wearable Device for Prevention of Opioid-Induced Respiratory Depression, Hypoxemia and Death

项目摘要/摘要 意义：在美国，阿片类药物每天导致250人死亡，其中大部分是呼吸骤停。 低氧血症(低血氧)，通常发生在呼吸骤停之前。及时 检测和纠正低氧血症可以挽救生命。Oxert EPO是一款可穿戴的 自动恢复呼吸和逆转低氧血症的设备 人为干预。 Oxert EPO(增强型脉搏血氧计)是FDA指定的突破性产品 设备，(...对危及生命的情况更有效的诊断或治疗...为 不存在同等的替代方案。为了病人的最大利益。 FDA认可我们最初提出的用于住院术后的适应症。 接受阿片类药物治疗的手术患者。我们打算确认两种住院治疗的可行性 而在家里，为了支持FDA后来的适应症，用于在家的患者 使用阿片类药物。医疗保险和医疗保险服务中心(CMS)现在将 FDA批准的突破设备自动报销。 初步数据：Zornow显示自动唤醒优于1：1 护理。17塞斯勒在一项1200人的研究中顺便证实了“唤醒效应” 术后住院病人。16 具体目标：AIM1)证明OxAlert唤醒装置用于修复的可行性 阿片类药物治疗术后患者的呼吸与低氧血症逆转。 AIM2)确定未来第二阶段研究的统计可扩展性需求。 AIM3)评估病人耐受性、护士喂养量和人为因素/可用性。 AIM4)比较以前在家庭使用时夜间氧气减饱和的程度 手术后，无论有没有Oxert干预。 摘要：突破性的设备状态应有助于FDA批准 奥克赛特EPO。具有良好风险的设备：21世纪以下的收益比率 Caures Act有资格减少FDA对冗长的上市前研究的重视，而不是 到上市后数据，以便加快患者访问。我们希望能找到 将此设备提供给所有可能受益的人的最短路径。

Project Summary/Abstract Significance: Opioids kill 250 persons daily in the US, mostly by respiratory arrest. Hypoxemia (low blood oxygen), typically precedes respiratory arrest. Timely detection and correction of hypoxemia saves lives. The Oxalert EPO is a wearable device designed to automatically restore breathing and reverse hypoxemia without human intervention. The Oxalert EPO (Enhanced Pulse Oximeter) is an FDA designated Breakthrough Device, (...more effective diagnosis or treatment for a life-threatening condition... for which no equivalent alternatives exist... in the best interests of patients.)24 The FDA recognizes our initial proposed Indication for Use in hospitalized post- operative patients receiving opioids. We intend to confirm feasibility both in-hospital and at home, in order to support a later FDA Indication for Use in patients at home using opioids. The Center for Medicare and Medicare Services (CMS) will now reimburse automatically for FDA-approved Breakthrough Devices. Preliminary Data: Zornow showed that automatic arousal was superior to 1:1 nursing care.17 Sessler incidentally verified the "Arousal Effect" in a study of 1200 post-op in-patients.16 Specific Aims: AIM1) Prove feasibility of the Oxalert arousal device for restoring breathing and reversing hypoxemia in post-operative patients receiving opioids. AIM2) Determine statistical scalability needs for future Phase II study. AIM3) Evaluate patient tolerance, nurse feedbacl and human factors/usability. AIM4) Compare the extent of nocturnal oxygen desatuations in home-use before and after surgery, with and without Oxalert interventions. Summary: Breakthrough Device status should facilitate FDA approval for the Oxalert EPO. Devices with a favorable Risk:Benefit ratio under the Twenty-First Cures Act qualify for less FDA emphasis on lengthy pre-market studies as opposed to post-market data in order to expedite patient access. We hope to find the shortest path to getting this device to all who might benefit.