University of Colorado, Denver
Retained foreign objects, such as surgical sponges, needles, or instruments, are rare but potentially serious complications of surgery. When there is concern that an object may have been left behind, an intraoperative radiograph may be obtained while the patient is still in the operating room. These radiographs can be difficult to interpret because of overlapping surgical equipment, patient positioning, and the need for rapid interpretation. This prospective observational study evaluates an artificial intelligence (AI) system designed to detect retained foreign objects on intraoperative radiographs. Eligible radiographs obtained during routine clinical care will be automatically processed by the AI system in real time for approximately one year. The AI results will not be shown to radiologists, surgeons, or other members of the clinical care team and will not affect patient care. The study will evaluate how accurately the AI system detects retained foreign objects and how reliably and quickly the system operates in a real-world clinical environment.
This is a prospective, non-interventional, silent observational study evaluating the real-world performance and operational feasibility of an artificial intelligence system for detection of retained foreign objects (RFOs) on intraoperative radiographs. Consecutive eligible OR count radiographs obtained during routine clinical care will be identified using institutional imaging protocol labels and automatically routed from the clinical imaging environment to a secure local research inference system within the institutional firewall. The AI system will process eligible images in real time and g…
Inclusion Criteria: * Age 18 years or older. * Undergoing intraoperative radiography during routine clinical care for evaluation of a possible retained foreign object. * Radiographic examination identified using the institutional OR count imaging protocol, including "XR OR COUNT PROTOCOL W/WO POSITIVE CONTROL" or an equivalent institutional protocol label used for OR count imaging during the study period. Exclusion Criteria: * Radiographic examination lacking usable imaging data. * Insufficient clinical or imaging information to establish an adequate reference standard for analysis.
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