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: 9345755
• 负责人: James Alan Feldman
• 金额: $ 50万
• 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 2019-05-20
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9345755
• 关键词: Abdomen; Accident and Emergency department; Acute; Algorithms; Ambulances; Anatomy; Ascites; Blood; Boston; Cessation of life; Collaborations; Collection; Communities; Community Hospitals; Computer software; Critical Care; Critical Illness; Data; Detection; Diagnostic; Electrocardiogram; Emergency Department Physician; Emergency Medicine; Emergency medical service; Environment; Evaluation; Gender; Hemorrhage; Hemorrhagic Shock; Hospitals; Image; Intra-abdominal; Journals; Laparotomy; Lead; Liquid substance; Measurement; Measures; Medical; Medical center; Medicine; Military Personnel; Movement; Operative Surgical Procedures; Outcome Measure; Pathology; Patients; Performance; Phase; Physicians; Positioning Attribute; Pre-hospital setting; Probability; Process; Provider; Randomized Clinical Trials; Receiver Operating Characteristics; Resources; Running; Rural Hospitals; Sensitivity and Specificity; Small Business Innovation Research Grant; Specificity; Surgeon; System; Tablets; Technology; Testing; Therapeutic; Time; Training; Transducers; Trauma; Triage; Ultrasonic Transducer; Ultrasonography; Undifferentiated; Universities; Woman; Work; combat; commercialization; cost; global health; graphical user interface; image processing; improved; information display; kinematics; mass casualty; medical schools; medical specialties; men; point of care; portability; public health relevance; rapid detection; research clinical testing; sensor; septic; standard of care; tool; usability; user-friendly

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. 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 prehospital settings including extreme environments like mass-casualty and combat zones. 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 and accurately interpret a FAST exam. The system will guide the operator through the image acquisition process and automatically compute a probability for abdominal free fluid. We have previously shown that image processing algorithms can detect free fluid with 100% sensitivity and 90% specificity in perihepatic (e.g., right upper quadrant) abdominal ultrasound views (J. Ultrasound in Medicine, In Press). In this Phase I SBIR project we will improve our image processing algorithms and validate them on FAST exams recorded using a portable ultrasound system. We will also develop a beta version of the system for usability testing and further clinical evaluation in Phase II. By the completion of Phase I the system will be able to concurrently record, and display in realtime, ultrasound images and ultrasound probe position and kinematics. Recording probe position and movement is important because it will assist the software in guiding a minimally trained operator through the image acquisition process. In Phase II we will develop operator guidance software and perform a randomized clinical trial to evaluate efficacy from the perspective of usability (can a minimally trained operator record a diagnostic quality exam) and performance (how much free fluid has to be present for the developed system to reliably detect it). The proposed technology has significant commercialization potential. Our first target market is emergency medical services including civilian ambulance companies and the U.S. military. Important use cases in this market include medical transport prioritization in mass-casualty and combat settings, as well as pre-hospital free-fluid assessment, particularly during longer transports. Our second target market is emergency departments with a focus on rural and community hospitals. Broader applications include use in resource limited global health medicine, as well as in many other specialties where non-trauma assessment of abdominal free fluid is necessary, such as the medically critically ill or to assess for ascites.

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。这是即时超声波检查 包含腹部的四个视图。在创伤中，腹部游离液体被认为是血液，直到 证明不是这样。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。在社区医院，FAST检查未得到充分利用，原因是获得 能够进行检查的医生（通常是急诊医生或创伤外科医生）。在 此外，超声波的低成本和便携性使其成为院前环境的理想分类工具， 极端环境，如大规模伤亡和战区。在这些情况下，检测腹部游离 流体将影响医疗运输的优先次序，并有助于分配有限的资源。 BioSensics与波士顿大学医学院合作，提出开发一种便携式 一个简单的超声系统，使操作员能够执行和准确地解释FAST检查。 系统将引导操作员完成图像采集过程，并自动计算 腹腔积液的可能性我们之前已经证明，图像处理算法可以检测到 游离液体在肝周具有100%的灵敏度和90%的特异性（例如，右上腹 超声视图（医学超声杂志，出版中）。在第一阶段SBIR项目中，我们将改善我们的形象 处理算法，并在使用便携式超声系统记录的FAST检查上验证它们。我们将 并开发一个测试版的系统，用于第二阶段的可用性测试和进一步的临床评估。由 第一阶段完成后，系统将能够同时记录和实时显示超声 图像和超声探头位置和运动学。记录探头位置和移动非常重要 因为它将帮助软件引导最低限度训练的操作员通过图像采集 过程在第二阶段，我们将开发操作员指导软件，并进行随机临床试验， 从可用性的角度评价有效性（接受过最低限度培训的操作员能否记录诊断质量 检查）和性能（开发的系统必须存在多少自由流体才能可靠地检测到它）。 该技术具有巨大的商业化潜力。我们的第一个目标市场是应急 医疗服务，包括民用救护车公司和美国军方。这方面的重要用例 市场包括在大规模伤亡和战斗环境中的医疗运输优先级，以及院前 自由流体评估，特别是在较长的运输过程中。我们的第二个目标市场是应急 重点是农村和社区医院。更广泛的应用包括在资源 有限的全球健康医学，以及许多其他专业，其中非创伤评估 腹腔游离液是必要的，如医学上的危重病或评估为腹水。