Intraoperative Imaging for Guidance, Patient Safety, and OR Quality Assurance

术中成像用于指导、患者安全和手术室质量保证

• 批准号: 8913171
• 负责人: JEFFREY H SIEWERDSEN
• 金额: $ 50.59万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-01 至 2018-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8913171
• 关键词: Address; Adverse event; Affect; American; Anatomy; Awareness; Body part; Cadaver; Caring; Cause of Death; Clinical; Clinical Research; Complication; Cone; Data; Development; Devices; Diagnostic Imaging; Diagnostic radiologic examination; Dose; Dose-Limiting; Emerging Technologies; Evaluation; Event; Feasibility Studies; Fluoroscopy; Foreign Bodies; Goals; Gossypium; Head and Neck Surgery; Health; Healthcare Systems; Hour; Image; Image-Guided Surgery; Imagery; Imaging technology; Injury; Intervention; Joints; Label; Laboratories; Mainstreaming; Manuals; Measurement; Measures; Medical Errors; Methods; Modeling; Morbidity - disease rate; Morphologic artifacts; Motivation; Needles; Operating Rooms; Operative Surgical Procedures; Patients; Performance; Porifera; Postoperative Period; Procedures; Process; Quality of Care; Rana; Relative (related person); Research; Retrospective Studies; Role; Safety; Site; Source; Spinal Cord; Surgeon; Surgical Error; System; Technology; Three-Dimensional Image; Three-Dimensional Imaging; Time; Transcend; Translating; Translations; Ursidae Family; Vertebral column; Work; arm; base; cone-beam computed tomography; cost; image guided; image reconstruction; image registration; improved; innovation; intraoperative imaging; loss of function; meetings; mortality; new technology; novel; patient safety; prospective; prototype; quality assurance; reconstruction; safety study; skull base; spine bone structure; standard of care; tool; trend

DESCRIPTION (provided by applicant): The toll of medical errors on the health of Americans is - perhaps surprisingly - enormous: approximately 8 times per day, surgeons operate on the wrong body part; over 40% of surgery patients meet with some form of adverse event; and taken together, medical errors constitute the sixth leading cause of death in the US and cost tens of billions of dollars per year to the healthcare system. With the operating room (OR) presenting a major source of such errors, the last decade saw a growing awareness and motivation to reduce preventable errors using new surgical workflow, checklists, preoperative time-outs, flat hierarchy in the OR, etc., but with little evidence to suggest a reversal of trends The proposed research brings intraoperative imaging technology to the fore motivated specifically to improve patient safety and OR quality assurance (QA). These advances leverage some of the same technologies emerging over the last decade for image-guided surgery - for example, intraoperative imaging (mobile C-arms for high-quality, low-dose 3D imaging), image registration (including 3D-2D and 3D-3D registration of intraoperative images with preoperative images and planning data), and image reconstruction (including model-based 3D image reconstruction methods demonstrating exciting advances in image quality and dose reduction in diagnostic imaging). In motivating such technology directly toward challenges of patient safety and OR QA, we realize a comparatively simple, low-cost form that could be well suited to mainstream utilization in a broad spectrum of surgeries (rather than limited to a fairly narrow scope of procedures requiring ever increasing levels of surgical precision despite complexity and cost). Specifically, we advance three enabling technologies to improve safety in the OR: (1) a new clinical prototype mobile C-arm ("S1") deployed for the first time in clinical studies; (2) 3-2D image registration to automatically localize the surgical target and device trajectories directl in single-shot fluoroscopy or mobile radiographs; and (3) model-based 3D image reconstruction enabling high-quality low-dose cone-beam CT and yield high-quality images even in the presence of surgical devices. These technologies are brought to bear on major challenges in spine surgery via 4 Specific Aims following natural surgical workflow: (1) Localization of target vertebrae by robust 3D-2D registration directly on intraoperative fluoroscopy; (2) Guidance by 3D-2D registration without conventional trackers and maintaining accuracy throughout the procedure; (3) Qualitative Verification of the surgical product using high-quality mobile C-arm cone-beam CT at the conclusion of the case to verify the surgical product and detect complications and retained foreign bodies; and (4) Quantitative Verification based on joint registration and reconstruction to quantitatively measure screw placement and detect pedicle breach. The research encompasses the development, evaluation, and translation of each technology from the laboratory to safety and feasibility in first clinical studies.

描述（由申请人提供）：医疗差错对美国人健康造成的损失可能令人惊讶地巨大：每天大约有8次，外科医生对错误的身体部位进行手术;超过40%的手术患者会遇到某种形式的不良事件;合在一起，医疗差错构成美国第六大死亡原因，并且每年给医疗保健系统造成数百亿美元的损失。随着手术室（OR）成为此类错误的主要来源，在过去十年中，人们越来越意识到并有动力使用新的手术工作流程、检查表、术前超时、OR中的扁平化层级等来减少可预防的错误，但是几乎没有证据表明趋势的逆转。所提出的研究将术中成像技术带到了前面，特别是为了提高患者的安全性和OR质量保证（QA）。这些进步利用了过去十年中出现的一些用于图像引导手术的相同技术-例如，术中成像（移动的C形臂，用于高质量、低剂量3D成像），图像配准（包括术中图像与术前图像和计划数据的3D-2D和3D-3D配准），和图像重建（包括基于模型的3D图像重建方法，在诊断成像中展示了令人兴奋的图像质量和剂量降低方面的进步）。在激励这种技术直接面对患者安全和OR QA的挑战时，我们实现了一种相对简单，低成本的形式，可以很好地适用于广泛手术中的主流应用（而不是局限于相当狭窄的手术范围，尽管复杂性和成本要求不断提高手术精度）。具体地，我们提出了三种使能技术来提高OR中的安全性：（1）在临床研究中首次部署的新的临床原型移动的C形臂（“S1”）;（2）3-2D图像配准，以在单次荧光透视或移动的射线照片中直接自动定位手术目标和装置轨迹;以及（3）基于模型的3D图像重建，即使在存在手术装置的情况下也能够实现高质量低剂量锥形束CT并产生高质量图像。这些技术通过遵循自然手术工作流程的4个特定目标来应对脊柱手术中的主要挑战：（1）直接在术中荧光透视下通过强大的3D-2D配准定位靶椎骨;（2）通过3D-2D配准进行引导，无需传统跟踪器，并在整个手术过程中保持准确性;（3）在病例结束时使用高质量移动的C形臂锥束CT对手术产品进行定性验证，以验证手术产品并检测并发症和残留异物;和（4）基于关节配准和重建的定量验证，以定量测量螺钉放置并检测椎弓根破裂。该研究包括开发，评估和翻译每种技术从实验室到安全性和可行性的第一次临床研究。