Point of Care Lung CT for Patients with Acute Respiratory Failure

摘要 急性呼吸衰竭患者的床旁肺部CT 在美国，每年有200万患者发生急性呼吸衰竭， 其中一半需要机械通气，超过20%在出院前死亡。 确定这些患者的潜在肺部病变对于确保他们 接受正确的治疗，但标准的胸部成像，便携式胸部X光检查， 在接受有创机械通气的患者中区分重要的肺部病理 通风.计算机断层扫描（CT）可以识别肺炎、胸腔积液和/或 肺栓塞（造影剂负荷），否则可能无法检测到。然而，风险和 将危重患者转移到常规CT扫描仪的负担是 在这个人群中安全地进行CT。重症监护室中的“床旁”CT扫描仪 (ICU)将改变为这些病人提供护理的方式。然而， 目前还不存在紧凑和低辐射但能够进行胸部CT成像的设备。 在这个SBIR第二阶段项目中，Xoran打算开发一种紧凑的、移动的 然而，高功能的系统，以提供床旁胸部CT图像，适用于 医院ICU，也可部署到野战医院或其他前线环境。这种努力建立了 基于先前商业化的紧凑型便携式平板CT技术， 应用，并利用软组织成像能力方面取得的重大进展 结构和原型便携式和紧凑的开放式龙门机构， 脊柱成像该项目包括使用更大的格式扩展成像能力 以快速帧速率操作的检测器，以便捕获肺内的较大体积 患者呼吸周期的限制。自屏蔽和自消毒功能将 以最大限度地提高安全性和优化工作流程。临床评价将在 密歇根大学与肺科和重症监护医生团队合作， 胸放射科和ICU护理领导，然后将建立安全性和临床实用性 床旁胸部CT系统，以支持FDA 510 k提交，从而获得批准 适应症和商业上可行产品。

Abstract Point of Care Lung CT for patients with Acute Respiratory Failure Two million patients develop acute respiratory failure requiring hospitalization in the US each year, with half requiring mechanical ventilation and more than 20% dying before discharge. Identifying underlying pulmonary pathologies in these patients is essential to ensuring they receive the right treatment, but standard chest imaging, a portable chest X-ray exam, poorly discriminates important pulmonary pathology in patients receiving invasive mechanical ventilation. Computed Tomography (CT) can identify pneumonia, pleural effusion, and/or pulmonary embolism (with contrast load) that may otherwise go undetected. Yet the risks and burden of moving critically ill patients to a conventional CT scanner is a significant barrier to safely performing CT in this population. A “point-of-care” CT scanner in the intensive care unit (ICU) would transform how care is provided to these patients. However, a portable device that is compact and low radiation yet capable of thoracic CT imaging does not currently exist. In this SBIR Phase II project, Xoran intends to develop and clinically validate a compact, mobile yet highly functional system to provide point of care thoracic CT images suitable for use in hospital ICUs and also deployable to field hospitals or other frontline settings. This effort builds on a previously commercialized compact and portable flat-panel CT technology for cranial applications, and leverages significant progress made in imaging capabilities for soft tissue structures in the brain and a prototype portable and compact open gantry mechanism intended for spine imaging. The project includes expansion of imaging capabilities using larger format detectors operating at fast frame rates in order to capture the larger volume of the lungs within the constraints of a patients breathing cycle. Self-shielding and self-disinfecting features will be incorporated to maximize safety and optimize workflows. Clinical evaluation will take place at the University of Michigan. Partnering with a team of Pulmonary and Critical Care physicians, thoracic radiology, and ICU nursing leadership, it will then establish the safety and clinical utility of point-of-care Thoracic CT system in support of FDA 510k submission leading to an approved indication for use and commercially viable product.