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

用于预防阿片类药物引起的呼吸抑制、低氧血症和死亡的可穿戴设备

• 批准号: 10012569
• 负责人: Lloyd Olson
• 金额: $ 34.93万
• 依托单位: LLOYD OLSON, MD, LLC
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-06-15 至 2021-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10012569
• 关键词: Admission activity; Apnea; Arousal; Blood; Breathing; Care given by nurses; Cessation of life; Critical Care; Data; Detection; Device Designs; Devices; Diagnosis; Discipline of Nursing; Drops; Evaluation; FDA approved; Frequencies; Future; Heart Arrest; Home environment; Hospitals; Human; Hypoxemia; Intervention; Letters; Life; Low Prevalence; Medical Device; Medicare; Monitor; Myocardial Infarction; Myocardial Ischemia; Nurses; Operative Surgical Procedures; Opioid; Outcome Measure; Overdose; Oxygen; Patients; Persons; Phase; Physiologic pulse; Postoperative Period; Prevention; Pulse Oximetry; Sample Size; Services; Stimulus; Tactile; Time; Ventilatory Depression; base; innovation; interest; opioid mortality; opioid use; patient tolerability; phase 2 study; post-market; prevent; respiratory; risk benefit ratio; success; usability; wearable device

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.

项目概要/摘要 意义：在美国，阿片类药物每天导致 250 人死亡，其中大部分是因呼吸停止而死亡。 低氧血症（低血氧）通常发生在呼吸停止之前。及时 低氧血症的检测和纠正可以挽救生命。 Oxalert EPO 是一款可穿戴设备 旨在自动恢复呼吸并逆转低氧血症的装置，无需 人为干预。 Oxalert EPO（增强型脉搏血氧计）是 FDA 指定的突破性产品 设备，（...对危及生命的疾病进行更有效的诊断或治疗... 不存在等效的替代方案......为了患者的最大利益。）24 FDA 认可我们最初提出的住院后使用适应症 接受阿片类药物治疗的手术患者。我们打算在医院内确认可行性 以及在家中，以支持后续 FDA 在家患者使用的指示 使用阿片类药物。医疗保险和医疗保险服务中心 (CMS) 现在将 自动报销 FDA 批准的突破性设备。 初步数据：Zornow 表明自动唤醒优于 1:1 17 塞斯勒在一项针对 1200 人的研究中偶然验证了“唤醒效应” 术后住院患者16 具体目标： AIM1) 证明 Oxalert 唤醒装置恢复的可行性 接受阿片类药物的术后患者的呼吸和逆转低氧血症。 AIM2) 确定未来第二阶段研究的统计可扩展性需求。 AIM3) 评估患者耐受性、护士反馈和人为因素/可用性。 AIM4) 比较之前在家使用时夜间氧饱和度下降的程度 以及手术后，有或没有 Oxalert 干预。 摘要：突破性设备状态应有助于 FDA 批准该产品 奥克斯勒特 EPO。具有良好风险收益比的设备 FDA 较少强调《治愈法案》对冗长的上市前研究的重视 上市后数据以加快患者访问速度。我们希望找到 让所有可能受益的人获得该设备的最短路径。

项目成果

Wearable device for prevention of postoperative and post-discharge hypoxemia: A randomized pilot trial.

用于预防术后和出院后低氧血症的可穿戴设备：一项随机试点试验。

• DOI: 10.1111/aas.14193
• 发表时间: 2023
• 期刊: Acta anaesthesiologica Scandinavica
• 影响因子: 2.1
• 作者: Li,Kai;Saab,Remie;Bravo,Mauro;Mascha,EdwardJ;Han,Yanyan;Nault,Rod;Olson,Lloyd;Sessler,DanielI
• 通讯作者: Sessler,DanielI