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.
Public Health Relevance Statement: Narrative / Relevance to Public Health 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. Bedside availability of a CT scanner in the intensive care unit could transform how care is provided to these patients, enabling accurate understanding of pulmonary pathology to ensure patients receive the right treatment. In this project, a lung CT imaging capability will be developed and clinically validated to enable "point of care" CT imaging, to help avoid the risks and delays associated with centralized imaging and provide an affordable solution for wide deployment.
Project Terms: Anatomy; Anatomic; Anatomic Sites; Anatomic structures; Anatomical Sciences; Breathing; Respiratory Aspiration; Respiratory Inspiration; inspiration; Atelectasis; ATLEC; Brain; Brain Nervous System; Encephalon; Critical Care; Critical Illness; Critically Ill; Diagnosis; effusion; Future; Patient Care; Patient Care Delivery; Glass; Goals; Hospitalization; Hospital Admission; Hospitals; Intensive Care Units; Investments; Leadership; Lung; Lung Respiratory System; pulmonary; Michigan; Noise; Discipline of Nursing; Nursing; Nursing Field; Nursing Profession; Ocular orbit; Eye Socket; Orbit; Orbital Cavity; Legal patent; Patents; Pathology; Patient Transfer; Patients; Physicians; Pleural effusion disorder; Pleural Effusion; pleural cavity effusion; Pneumonia; Public Health; Pulmonary artery structure; Pulmonary Artery; Pulmonology; Pneumology; Pneumonology; Pulmonary Medicine; Pulmonary Embolism; Radiology Specialty; General Radiology; Radiology; Research Personnel; Investigators; Researchers; Risk; Safety; Sales; Vertebral column; Spinal Column; Spine; backbone; Supervision; Supination; Technology; Thoracic Radiography; CXR; chest X ray; chest Xray; chest radiography; lung radiography; radiographic chest image; radiographic lung image; thoracic radiogram; thorax radiography; X-Ray Computed Tomography; CAT scan; CT X Ray; CT Xray; CT imaging; CT scan; Computed Tomography; Tomodensitometry; X-Ray CAT Scan; X-Ray Computerized Tomography; Xray CAT scan; Xray Computed Tomography; Xray computerized tomography; catscan; computed axial tomography; computer tomography; computerized axial tomography; computerized tomography; Triage; Universities; Work; Roentgen Rays; X-Radiation; X-Ray Radiation; X-ray; Xray; Intensive Care; Device Designs; Specialist; Caring; human subject; detector; Procedures; Mechanical ventilation; mechanical respiratory assist; mechanically ventilated; lung imaging; Pulmonary imaging; lung scanning; Cephalic; Cranial; Peripheral; Clinical; Phase; Medical; Series; Ensure; Evaluation; soft tissue; expiration; lung volume; Measurement; Funding; radiologist; Acute respiratory failure; Scanning; System; Viral; respiratory; Cardiopulmonary; Services; Speed; Structure; novel; Devices; lung pathology; Pulmonary Pathology; Thorace; Thoracic; Thorax; Chest; Radiation; response; portability; Adverse Experience; Adverse event; Computed Tomography Scanners; image-based method; imaging method; imaging modality; Thickness; Thick; Dose; Data; research clinical testing; Clinical Evaluation; Clinical Testing; clinical test; Enrollment; enroll; Slice; Small Business Innovation Research Grant; SBIR; Small Business Innovation Research; Monitor; point of care; pandemic disease; pandemic; Image; imaging; reconstruction; design; designing; Outcome; Population; clinically relevant; clinical relevance; commercial application; prototype; high risk; routine care; Institutional Review Boards; IRB; IRBs; safety and feasibility; imaging capabilities; Injections; Patient imaging; Visualization
