3D ultrasound for bone fracture diagnosis in emergency medicine

项目摘要/摘要 因过度拥挤而导致的急诊科(ED)每天等待时间过长的比例为10%至 30%的医院和90%的医院每周至少一次。人们普遍认为，漫长的等待时间 与由于缺乏及时性和无法进行治疗而导致的不良健康结果有关。而当 急诊等待时间延长的原因有很多，其中一个主要原因是对放射科的高需求 每年向美国急诊科医生提供4700万次X光检查。虽然许多X光检查通常是为了 时间紧迫的患者，~1700万名疑似骨折患者获得，50% 其中一些是简单几何形状的骨骼中的“常规”。除了放射学积压造成的延误外， 在急诊室获取X光是一项耗费资源和时间的工作。此过程通常涉及以下内容： 在X光机上安排时间，将患者运送到X光机，获取X光图像(S)， 将患者和影像结果传输回急诊室，从放射科医生处获得处置，以及 向急诊科或骨科医生传达意向。每张ED订购的X光片耗费&gt；30分钟 额外的&gt；30分钟以获得放射科医生的处理能力。这一过程给美国带来的总成本 医疗保健系统估计耗资32亿美元。 在第一阶段项目中，三维超声成像系统和新技术的可行性 在体外骨折模型中进行了演示。3D超声图像由两个独立的 诊断骨折的ED医生的灵敏度和特异度分别为100%和96%。本第二阶段建议书 寻求资金支持继续开发用于骨折的三维超声成像系统 侦测。该项目的关键技术创新集中在对基于超声的 骨骼可视化，并包括一个新的临床医生辅助功能，使自动检测疑似 骨折。该项目的长期目标是演示一种3D骨骼成像超声系统，该系统 促进骨折的快速检测，加快急诊科内的护理提供，以及 降低与延误提供治疗有关的健康并发症的风险。 第二阶段的假设是，3D超声骨成像系统将表现出基本上相同的 数字化X线诊断急诊患者骨折的敏感性和特异性 疑似长骨骨折的科室。该项目的核心是新的超声成像技术 将被优化，集成到3D超声骨骼成像系统中，并在尸检中进行验证 人类受试者和人类临床研究。最后，第二阶段假说将在135名患者中进行测试 临床研究。据估计，在全球约5,000个急诊室中有850万例疑似骨折病例 美国每年，这种拟议的超声成像设备在美国的市场规模估计为2亿美元/年。

PROJECT SUMMARY/ABSTRACT Long emergency department (ED) wait times resulting from overcrowding occur on a daily basis in 10% to 30% of hospitals and at least once per week in 90% of hospitals. It is widely acknowledged that long wait times are correlated to poor health outcomes due to lack of timeliness and inability to administer treatment. While there are many causes of prolonged ED wait times, a predominant source is the high demand for radiology services, which provide 47 million X-rays to US EDs each year. While many X-rays are often performed for patients with time critical conditions, ~17 million are acquired for patients with suspected bone fractures, 50% of which are “routine” in bones with simple geometries. In addition to delays caused by radiology backlog, acquiring an X-ray in the ED is resource and time consuming. This process typically involves the following: arrange time on the X-ray machine, transport the patient to the X-ray machine, acquire the X-ray image(s), transport the patient and image results back to the ED, acquire a disposition from the radiologist, and communicate disposition to the ED or orthopedic physician. Each ED-ordered X-ray consumes > 30 minutes with an additional > 30 minutes to acquire a radiologist disposition. The total cost of this process to the US healthcare system is an estimated $3.2B. During the Phase I project, the feasibility of a 3D ultrasound imaging system and new technologies was demonstrated in an ex vivo bone fracture model. The 3D ultrasound images were reviewed by two independent ED physicians who detected bone fractures with 100% sensitivity and 96% specificity. This Phase II proposal seeks funding to support the continued development of a 3D ultrasound imaging system for bone fracture detection. The key technological innovations of this project are focused on improvements to ultrasound-based bone visualization and include a new clinician-assist feature that enables automatic detection of suspected bone fractures. The long-term goal of this project is to demonstrate a 3D bone-imaging ultrasound system that facilitates the rapid detection of bone fractures, expedites care delivery within the Emergency Department, and lowers the risk of health complications associated with delays in treatment delivery. The Phase II hypothesis is that the 3D ultrasound bone imaging system will exhibit substantially equivalent sensitivity and specificity as digital X-ray for the detection of fractures in patients presenting to the Emergency Department with suspected long bone fractures. Novel ultrasound imaging technologies central to this project will be optimized, integrated into the 3D ultrasound bone imaging system, and validated in both post-mortem human subjects and human clinical studies. Finally, the Phase II hypothesis will be tested in a 135 patient clinical study. With an estimated 8.5 million suspected bone fracture cases in approximately 5,000 EDs across the US each year, the estimated US market size for this proposed ultrasound imaging device is $200 M/yr.