Portable Ultrasound System for Automated Detection of Abdominal Free-Fluid

用于自动检测腹部游离液体的便携式超声系统

• 批准号: 9907383
• 负责人: James Alan Feldman
• 金额: $ 81.81万
• 依托单位: BIOSENSICS, LLC
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-08-11 至 2022-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9907383
• 关键词: Abdomen; Accident and Emergency department; Acute; Algorithms; Ambulances; Ascites; Blood; Boston; Cessation of life; Classification; Code; Collaborations; Communities; Community Hospitals; Computer software; Computers; Critical Care; Data; Detection; Development; Diagnostic; Electrocardiogram; Emergency Department Physician; Emergency Medical Technicians; Emergency Medicine; Emergency medical service; Environment; Feedback; Female; Hemorrhage; Hemorrhagic Shock; Image; Instruction; Intra-abdominal; Laparotomy; Lead; Liquid substance; Measures; Medical; Military Personnel; Modeling; Motion; Movement; Operative Surgical Procedures; Outcome Measure; Participant; Pathology; Patients; Phase; Physicians; Positioning Attribute; Pre-hospital setting; Prevalence; Probability; Process; Provider; Published Comment; Receiver Operating Characteristics; Records; Research Personnel; Resources; Rest; Retrospective Studies; Rural Hospitals; Sensitivity and Specificity; Small Business Innovation Research Grant; Specificity; Speed; Surgeon; Surveys; System; Technology; Testing; Therapeutic; Time; Training; Trauma; Triage; Ultrasonography; Undifferentiated; Universities; Work; base; cohort; combat; commercialization; cost; gender difference; healthy volunteer; image processing; improved; innovation; kinematics; male; mass casualty; medical schools; point of care; portability; public health relevance; rapid detection; response; septic; standard of care; statistics; tool; usability

PROJECT SUMMARY / ABSTRACT The Focused Assessment with Sonography in Trauma (FAST) exam is the standard of care for rapid detection of abdominal free fluid in emergency medicine and trauma critical care. It is a point-of-care ultrasound exam that incorporates four views of the abdomen. In trauma, abdominal free fluid is assumed to be blood until proven otherwise. Timely detection is critical because if untreated abdominal hemorrhage can rapidly lead to hemorrhagic shock and death. Performing and interpreting a FAST exam requires appropriate training and practice. In community hospitals the FAST exam is underutilized due to limited access to physicians who are able to perform the exam (typically an emergency physician or trauma surgeon). In addition, the low cost and portability of ultrasound make it an ideal triage tool for pre-hospital settings. In these settings, detection of abdominal free fluid would impact medical transport prioritization and aid in the distribution of limited resources. BioSensics, in collaboration with Boston University School of Medicine, proposes to develop a portable ultrasound system to enable a minimally trained operator to perform a FAST exam. The system will guide the operator through the image acquisition process and automatically compute a probability for abdominal free fluid. A fundamental innovation is that ultrasound probe position and orientation, with respect to the patient, will be measured and used to inform both the image processing system and the operator guidance system. Feasibility of the image processing component of the system has been demonstrated through two retrospective studies of perihepatic (e.g., right upper quadrant) abdominal ultrasound views. In the first study (prior to our Phase I SBIR) abdominal free fluid was identified with 100% sensitivity and 90% specificity in a cohort of 20 FAST exams mostly from medical causes of abdominal free fluid, such as ascites. In the second study (during Phase I of this project) abdominal free fluid was identified with 81% sensitivity and 88% specificity in a cohort of 47 cases of hemoperitoneum and 51 negative controls (classification of hemoperitoneum, especially from trauma, is more difficult because the free fluid volume is often smaller). In addition, during Phase I we built an ultrasound system that records the position and orientation of the probe during the image acquisition process. The objectives of this Phase II SBIR project are the following: 1) develop validate image processing algorithms to compute a probability for the presence of abdominal free fluid in all four FAST exam views by expanding on the prior work done for the perihepatic view; and 2) develop and test software to enable a minimally trained user to perform a FAST exam by providing real-time guidance based on probe position and orientation. The proposed technology has significant commercialization potential. Our first target market is emergency medical services (EMS) including civilian ambulance companies and the US military. Our second target market is emergency departments with a particular focus on rural and community hospitals. More broadly, the technology could aid in many settings where non-trauma assessment of abdominal free fluid is necessary.

项目摘要 /摘要 在创伤（快速）检查中进行超声检查的重点评估是快速检测的护理标准 急诊医学和创伤重症监护中的腹部无腹部液体。这是一项护理点超声检查 结合了腹部的四个观点。在创伤中，假定腹部自由液为血液直到证明 否则。及时检测至关重要，因为如果未处理的腹部出血会迅速导致 出血冲击和死亡。进行和解释快速考试需要适当的培训，并且 实践。在社区医院中，由于与医生的机会有限，快速检查未被充分利用 能够进行考试（通常是急诊医师或外科医生）。此外，低成本和 超声的可移植性使其成为院前环境的理想分类工具。在这些设置中，检测 腹部无液体会影响医疗运输优先级，并有助于分配有限的资源。 与波士顿大学医学院合作的生物密度学提议开发便携式 超声系统使训练有素的操作员能够进行快速检查。该系统将指导 通过图像采集过程进行操作员，并自动计算腹部自由流体的概率。 基本创新是，相对于患者的超声探针位置和方向将是 测量并用于告知图像处理系统和操作员指导系统。可行性 通过两个回顾性研究，已经证明了系统的图像处理组件 丘脑（例如，右上象限）腹部超声视图。在第一项研究中（在我们的第一阶段SBIR之前） 在20个快速检查中，鉴定出具有100％灵敏度和90％特异性的腹部无液体 来自腹部无腹部液体的医学原因，例如腹水。在第二项研究（在该项目的第一阶段期间） 在47例的队列中，鉴定出具有81％灵敏度的腹部无液体和88％的特异性 血管内酮和51个阴性对照（尤其是创伤的疾病分类，更多是 很难，因为自由流体量通常较小）。此外，在第一阶段，我们构建了一个超声系统 在图像采集过程中，记录了探针的位置和方向。 此II阶段SBIR项目的目标如下：1）开发验证图像处理算法 通过扩展，在所有四个快速考试中都可以计算出在所有四个快速考试中存在腹部无液体的概率 对脊椎动物视图所做的先前工作； 2）开发和测试软件以启用最低培训的用户 通过基于探针位置和方向提供实时指导来进行快速考试。提议 技术具有巨大的商业化潜力。我们的第一个目标市场是紧急医疗服务 （EMS），包括平民救护车公司和美军。我们的第二个目标市场是紧急情况 特别关注农村和社区医院的部门。更广泛地，该技术可以帮助 许多设置需要对腹部无动液进行非创伤评估。