Point of Care Lung CT for Patients with Acute Respiratory Failure

摘要 急性呼吸衰竭患者的肺部CT检查护理要点 美国有200万名患者出现急性呼吸衰竭需要住院治疗 其中一半需要机械通风，超过20%的人在出院前死亡。 确定这些患者潜在的肺部病理对于确保他们 接受正确的治疗，但标准的胸部成像，便携式胸部X光检查，效果不佳 对接受有创机械治疗的患者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(有造影剂负荷)，否则可能无法发现。然而，风险和 将危重患者转移到传统CT扫描仪的负担是实现以下目标的重要障碍 在这一人群中安全地进行CT检查。重症监护病房中的“点式”CT扫描仪 (ICU)将改变向这些患者提供护理的方式。然而，一款便携设备 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打算开发并在临床上验证一种紧凑型、移动式 功能强大的系统，可提供适用于以下疾病的护理点胸部CT图像 医院重症监护室，也可部署到野战医院或其他前线环境。这一努力建立了 一种先前商业化的紧凑型便携平板CT颅脑CT技术 应用，并利用在软组织成像能力方面取得的重大进展 大脑结构和设计的便携式紧凑型开放式龙门机构原型 用于脊柱成像。该项目包括使用更大的格式扩展成像能力 探测器以快速帧速率工作，以便捕获更大体积的肺 病人呼吸周期的限制。自我屏蔽和自我消毒功能将是 整合以最大限度地提高安全性和优化工作流程。临床评估将在以下时间进行 密歇根大学。与肺部和重症监护医生团队合作， 胸科、放射科和ICU护理的领导，才能确立其安全性和临床实用性 支持FDA 510k提交的护理点胸部CT系统导致批准 使用说明和商业上可行的产品。

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.