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.

项目概要/摘要 创伤超声重点评估 (FAST) 检查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游离液体。这是一种即时超声检查 包含腹部的四个视图。在外伤中，腹部游离液体被认为是血液，直到得到证实 否则。及时发现至关重要，因为如果不及时治疗腹部出血会迅速导致 失血性休克和死亡。执行和解释 FAST 考试需要适当的培训和 实践。在社区医院，由于接触到的医生有限，FAST 检查并未得到充分利用。 能够进行检查（通常是急诊科医生或创伤外科医生）。此外，低成本和 超声的便携性使其成为院前环境的理想分诊工具。在这些设置中，检测 腹部游离液体将影响医疗运输的优先顺序并有助于分配有限的资源。 BioSensics 与波士顿大学医学院合作，提议开发一种便携式 超声系统使经过最低限度培训的操作员能够执行快速检查。系统将引导 操作员通过图像采集过程自动计算腹部无液体的概率。 一项根本性的创新是超声探头相对于患者的位置和方向将是 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的功能已通过两项回顾性研究得到证明 肝周（例如右上象限）腹部超声视图。在第一项研究中（在我们的第一阶段 SBIR 之前） 在 20 次 FAST 检查的队列中，以 100% 的敏感性和 90% 的特异性鉴定腹部游离液体 由于医学原因导致腹部游离液体，例如腹水。在第二项研究中（在该项目的第一阶段） 在 47 例患者的队列中，确定腹部游离液体的敏感性为 81%，特异性为 88% 腹腔积血和 51 个阴性对照（腹腔积血的分类，尤其是来自外伤的腹腔积血，更 困难，因为自由流体体积通常较小）。此外，在第一阶段我们建造了一个超声波系统 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 通过扩展来计算所有四个 FAST 检查视图中存在腹部游离液体的概率 之前为肝周视图所做的工作； 2) 开发和测试软件以支持经过最低限度培训的用户 通过根据探头位置和方向提供实时指导来执行 FAST 检查。拟议的 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紧急的 特别关注农村和社区医院的部门。更广泛地说，该技术可以帮助 在许多情况下，需要对腹部游离液体进行非创伤性评估。