Development of a regional anesthesia guidance system to increase patient access to opioid-sparing analgesia for hip fracture pain

开发区域麻醉引导系统，以增加患者获得髋部骨折疼痛的阿片类药物保留镇痛的机会

• 批准号: 10759550
• 负责人: Frank William Mauldin
• 金额: $ 101.19万
• 依托单位: RIVANNA MEDICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-11 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10759550
• 关键词: 3-Dimensional; Absence of pain sensation; Accident and Emergency department; Acute; Acute Pain; Address; Admission activity; Algorithms; American; Anatomy; Anesthesia procedures; Cadaver; Certification; Clinical; Collaborations; Competence; Computer software; Conduction Anesthesia; Delirium; Detection; Development; Emergency Department Physician; Funding; Goals; Helping to End Addiction Long-term; Hip Fractures; Hip region structure; Hospitalization; Hospitals; Human; Image; Injections; Intelligence; International; Intuition; Learning; Length of Stay; Machine Learning; Manufacturer; Marketing; Measurement; Medical Device; Methodology; Modality; Needles; Nerve; Nerve Block; Operative Surgical Procedures; Opioid; Pain; Pain management; Patients; Persons; Phase; Physicians; Positioning Attribute; Procedures; Production; Provider; Reader; Recurrence; Research Project Grants; Risk Reduction; Sensitivity and Specificity; Site; Specific qualifier value; Specimen; Sterility; System; Techniques; Technology; Tendon structure; Three-Dimensional Imaging; Time; Training; Ultrasonography; Validation; Work; X-Ray Computed Tomography; adverse event risk; adverse outcome; bone; clinical application; clinical trial readiness; commercial application; commercialization; deep learning; design; experience; fabrication; falls; hip bone; human imaging; image guided; image visualization; imaging study; imaging system; improved; improved outcome; innovation; learning network; manufacture; mortality risk; non-opioid analgesic; novel; opioid sparing; opioid use; point of care; pre-clinical; preclinical study; primary endpoint; product development; prototype; reconstruction; response; soft tissue; standard of care; success; technological innovation; therapy development; ultrasound; usability; validation studies; 3-Dimensional; Absence of pain sensation; Accident and Emergency department; Acute; Acute Pain; Address; Admission activity; Algorithms; American; Anatomy; Anesthesia procedures; Cadaver; Certification; Clinical; Collaborations; Competence; Computer software; Conduction Anesthesia; Delirium; Detection; Development; Emergency Department Physician; Funding; Goals; Helping to End Addiction Long-term; Hip Fractures; Hip region structure; Hospitalization; Hospitals; Human; Image; Injections; Intelligence; International; Intuition; Learning; Length of Stay; Machine Learning; Manufacturer; Marketing; Measurement; Medical Device; Methodology; Modality; Needles; Nerve; Nerve Block; Operative Surgical Procedures; Opioid; Pain; Pain management; Patients; Persons; Phase; Physicians; Positioning Attribute; Procedures; Production; Provider; Reader; Recurrence; Research Project Grants; Risk Reduction; Sensitivity and Specificity; Site; Specific qualifier value; Specimen; Sterility; System; Techniques; Technology; Tendon structure; Three-Dimensional Imaging; Time; Training; Ultrasonography; Validation; Work; X-Ray Computed Tomography; adverse event risk; adverse outcome; bone; clinical application; clinical trial readiness; commercial application; commercialization; deep learning; design; experience; fabrication; falls; hip bone; human imaging; image guided; image visualization; imaging study; imaging system; improved; improved outcome; innovation; learning network; manufacture; mortality risk; non-opioid analgesic; novel; opioid sparing; opioid use; point of care; pre-clinical; preclinical study; primary endpoint; product development; prototype; reconstruction; response; soft tissue; standard of care; success; technological innovation; therapy development; ultrasound; usability; validation studies

PROJECT SUMMARY/ABSTRACT For the >330,000 Americans that are hospitalized for hip fractures yearly, rapid treatment of pain and surgical intervention is critical to recover mobility and reduce the risk of death. Parenteral opioids are the standard of care to manage acute hip fracture pain but increase the risk of adverse events and outcomes, including delirium and recurrent opioid use. Ultrasound-guided regional anesthesia (UGRA) techniques, such as the pericapsular nerve group (PENG) block, are an effective alternative to opioids that could be used for > 300,000 patients annually to decrease consumption of opioids and improve outcomes. However, utilization of UGRA in the emergency department (ED) is primarily limited by ED-specific workflow challenges and lack of access to the training required for competency. Thus, there is a clear need to increase utilization of opioid-sparing UGRA for hip fracture pain, and it is likely that a technological advancement that reduces the training and workflow requirements of administering UGRA is required to meet this need. During this project, an ultrasound-based hip regional anesthesia guidance system will be developed under a quality management system (QMS) certified to ISO 13485:2016 and 21 CFR Part 820. The key technological innovations underpinning the development of this product include the following: 2D and 3D imaging algorithms that highlight bony anatomy and soft tissue landmarks, anatomical recognition capabilities that automate injection site selection, a novel dual-array ultrasound probe that enables ‘through-the-probe’ needle trajectories, a single-use sterile consumable designed to simplify workflow, and a needle-visualization imaging mode that highlights the advancing needle to the user. The primary technical tasks during the early stages of the project period include the execution of end-user clinical usability studies to guide technical specification development and implementation of machine learning networks to guide the PENG block. Successful completion of these technical aims will result in the fabrication of pre-production systems for pre- clinical validation studies that will be conducted later in the project period. Pre-clinical product validation activities will include cadaver and human-imaging studies performed in collaboration with clinical experts who will verify that the system meets the requirements for the clinical application. The primary endpoint for the pre-clinical cadaveric studies is a direct measurement of the accuracy of needle placement for the PENG block, as confirmed by CT imaging. Additionally, a second pre-clinical study using cadaveric specimens will characterize the learning curve required to reach competency with the system by studying the needle placement accuracy achieved by 25 ED physicians over multiple simulated procedures. Completion of this research project will result in the development and fabrication of a human clinical- trial-ready 3D-capable ultrasound-imaging system to support facile administration of UGRA for hip fracture pain by minimizing training and workflow barriers to utilization.

项目摘要/摘要 对于每年住院的髋部骨折住院的> 330,000名美国人，疼痛和手术的快速治疗 干预对于恢复流动性和降低死亡风险至关重要。肠胃外阿片类药物是 注意管理急性髋部骨折疼痛，但会增加发生不良事件和结果的风险，包括 del妄和反复使用阿片类药物。超声引导的区域麻醉（UGRA）技术，例如 周围神经群（PENG）块，是阿片类药物的有效替代品，可用于> 300,000 每年患者减少阿片类药物的消耗并改善预后。但是，在 急诊科（ED）主要受到特定于ED的工作流挑战的限制，并且无法获得 能力所需的培训。这很明显需要增加对阿片类药物的ugra的利用 对于髋部骨折疼痛，可能会减少培训和工作流程的技术进步 需要管理UGRA的要求才能满足这一需求。 在此项目中，将开发基于超声的髋关节区域麻醉引导系统 在ISO 13485：2016和21 CFR第820部分认证的质量管理系统（QMS）下。 该产品开发的基础的技术创新包括以下内容：2D和3D 突出显示骨解剖学和软组织地标，解剖学识别能力的成像算法 该自动注入站点选择，这是一种新型的双阵列超声探针，可实现“探针” 针线轨迹，一种旨在简化工作流程的一次性无菌易用的无菌，以及针刺性的 成像模式突出了向用户前进的针头。早期的主要技术任务 项目期间的阶段包括执行最终用户临床可用性研究以指导技术 机器学习网络的规范开发和实施，以指导彭块。 这些技术目标的成功完成将导致制造预生产系统，以预先制作 临床验证研究将在项目期间进行。 临床前产品验证活动将包括尸体和人类成像研究 与临床专家的合作，他们将验证该系统满足临床要求 应用。临床前尸体研究的主要终点是直接测量精度 通过CT成像确认，彭块的针头放置。此外，第二次临床前研究 使用尸体标本将表征与系统达到能力所需的学习曲线 通过研究25位ED医生在多个模拟程序中准确实现的针头放置。 该研究项目的完成将导致人类临床的发展和制造 可以试用的3D能力超声图像系统，以支持轻松施用UGRA髋部骨折疼痛 通过最大程度地减少利用培训和工作流障碍。