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

基本信息

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
项目类别：
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

项目摘要

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，直到事实证明并非如此。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。在社区医院，由于获得的机会有限，FAST 检查未得到充分利用能够进行检查的医生（通常是急诊科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诊工具，包括大规模伤亡和战区等极端环境。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并准确解释 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部游离液体的概率。我们之前已经证明图像处理算法可以检测肝周（例如右上象限）腹部游离液体的敏感性为 100%，特异性为 90% 超声视图（J. Ultrasound in Medicine，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 检查中验证它们。我们将还开发了该系统的测试版，用于可用性测试和第二阶段的进一步临床评估。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很重要因为它将协助软件指导经过最低限度培训的操作员完成图像采集过程。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估功效（经过最低限度培训的操作员是否可以记录诊断质量检查）和性能（开发的系统必须存在多少游离液体才能可靠地检测到它）。所提出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情况医疗服务，包括民用救护车公司和美国军队。这方面的重要用例市场包括大规模伤亡和战斗环境中的医疗运输优先，以及院前急救自由液体评估，特别是在较长的运输过程中。我们的第二个目标市场是紧急的重点关注农村和社区医院的部门。更广泛的应用包括在资源中的使用有限的全球健康医学以及许多其他专业，其中非创伤评估腹部游离液体是必要的，例如病情危重或评估腹水。