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.

项目总结/摘要 创伤超声聚焦评估（FAST）检查是快速检测的护理标准 腹部游离液体在急诊医学和创伤重症监护中的应用。这是一种即时超声检查， 包括腹部的四个视图。在创伤中，腹部游离液体在被证实之前被认为是血液 否则及时发现是至关重要的，因为如果未经治疗的腹腔出血可迅速导致 失血性休克和死亡。执行和解释FAST检查需要适当的培训， 实践在社区医院，FAST检查未得到充分利用，原因是获得专业医生的机会有限， 能够进行检查（通常是急诊医生或创伤外科医生）。此外，低成本和 超声波的便携性使其成为院前环境的理想分类工具。在这些情况下， 腹部游离液体将影响医疗运输优先化并有助于有限资源的分配。 BioSensics与波士顿大学医学院合作，提出开发一种便携式 超声系统，使最低限度的培训操作员进行快速检查。该系统将引导 操作员通过图像采集过程自动计算腹部游离液体的概率。 一个根本的创新是，超声探头相对于患者的位置和取向将被确定。 测量并用于通知图像处理系统和操作员引导系统。可行性 该系统的图像处理组件已经通过两项回顾性研究得到了证明， 肝周（例如，右上象限）腹部超声视图。在第一项研究中（在我们的I期SBIR之前） 在20次FAST检查的队列中，腹腔游离液体的识别灵敏度为100%，特异性为90%， 来自腹部游离液体的医学原因，例如腹水。在第二项研究中（本项目第一阶段） 在47例腹腔积液患者中， 腹腔积血和51例阴性对照（腹腔积血的分类，特别是创伤， 因为自由流体体积通常较小，所以困难）。此外，在第一阶段，我们建立了一个超声系统， 其记录图像采集过程中探头的位置和方向。 第二阶段SBIR项目的目标如下：1）开发验证图像处理算法 通过扩展以下内容，计算所有四个FAST检查视图中存在腹部游离液体的概率 先前为肝周视图所做的工作;以及2）开发和测试软件，以使经过最低限度培训的用户 通过基于探头位置和方向提供实时指导来执行FAST检查。拟议 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)包括民用救护车公司和美国军方。我们的第二个目标市场是应急 重点是农村和社区医院。更广泛地说，这项技术可以帮助 在许多情况下，需要对腹部游离液体进行非创伤性评估。