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: 9348652
• 负责人: JEFFREY H SIEWERDSEN
• 金额: $ 51.29万
• 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 2019-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9348652
• 关键词: Address; Adverse event; Affect; American; Anatomy; Awareness; Body part; Cadaver; Caring; Cause of Death; Clinical; Clinical Research; Complication; Data; Development; Devices; Diagnostic Imaging; Diagnostic radiologic examination; Dose; 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; Mainstreaming; Manuals; Measurement; Measures; Medical Errors; Methods; Modeling; Morbidity - disease rate; Morphologic artifacts; Motivation; Needles; Operating Rooms; Operating System; Operative Surgical Procedures; Patients; Performance; Pilot Projects; Porifera; Postoperative Period; Procedures; Process; Quality of Care; Rana; Research; Retrospective Studies; Role; Safety; Site; Source; Spinal Cord; Spine surgery; Surgeon; Surgical Error; System; Technology; Three-Dimensional Image; Three-Dimensional Imaging; Time; Transcend; Translating; Translations; Ursidae Family; Work; arm; base; c new; comparative; cone-beam computed tomography; cost; image guided; image reconstruction; image registration; improved; innovation; intraoperative imaging; laboratory equipment; loss of function; mortality; new technology; novel; patient safety; prospective; prototype; public health relevance; quality assurance; reconstruction; safety and feasibility; 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）：对美国人健康的医疗错误损失 - 也许令人惊讶的是 - 巨大：每天大约8次，外科医生在错误的身体部位上操作；超过40％的手术患者发生某种形式的不良事件；总而言之，医疗错误构成了美国的第六大死亡原因，每年为医疗保健系统造成数百亿美元。 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).这些进步利用了过去十年中出现的一些相同的技术进行图像引导的手术 - 例如，术中成像（用于高质量，低剂量3D成像的移动C型臂），图像注册，图像注册（包括3D-2D和3D-2D和3D-3D - 3D - 3D注册），包括术前图像和图像的图像图像，包括图像和图像的图像，图像的图像，以及图像的图像，图像的图像概述（诊断成像中图像质量和降低剂量的进步）。在激励这种技术直接面对患者安全和 /质量检查的挑战时，我们意识到一种相对简单，低成本的形式，可以很好地适合于广泛的手术中的主流利用（而不是仅限于相当狭窄的手术范围，即使需要增加的手术精度和成本，则需要增加手术的精度和成本）。具体而言，我们推进了三种能力技术，以提高OR：（1）首次在临床研究中部署的新临床原型移动C-ARM（“ S1”）； （2）3-2D图像注册，以自动将手术目标和设备轨迹定位为单发荧光镜或移动X光片的直接； （3）基于模型的3D图像重建，即使在存在手术设备的情况下，也可以使高质量的低剂量锥束CT并产生高质量的图像。自然手术工作流程后，通过4个特定目的在脊柱手术的主要挑战中带来了这些技术：（1）通过稳健的3D-2D注册直接在术中荧光镜检查上定位目标椎骨； （2）在没有常规跟踪器的情况下通过3D-2D注册进行指导，并在整个过程中保持准确性； （3）在案件结束时使用高质量的移动C臂锥形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并保留异物； （4）基于联合注册和重建的定量验证，以定量测量螺钉放置并检测椎弓根漏洞。该研究涵盖了第一批临床研究中从实验室到安全性和可行性的每种技术的开发，评估和翻译。

项目成果

Automatic localization of target vertebrae in spine surgery: clinical evaluation of the LevelCheck registration algorithm.

• DOI: 10.1097/brs.0000000000000814
• 发表时间: 2015-04-15
• 期刊: Spine
• 影响因子: 3
• 作者: Lo SF;Otake Y;Puvanesarajah V;Wang AS;Uneri A;De Silva T;Vogt S;Kleinszig G;Elder BD;Goodwin CR;Kosztowski TA;Liauw JA;Groves M;Bydon A;Sciubba DM;Witham TF;Wolinsky JP;Aygun N;Gokaslan ZL;Siewerdsen JH
• 通讯作者: Siewerdsen JH

Multi-stage 3D-2D registration for correction of anatomical deformation in image-guided spine surgery.

• DOI: 10.1088/1361-6560/aa6b3e
• 发表时间: 2017-06-07
• 期刊: Physics in medicine and biology
• 影响因子: 3.5
• 作者: Ketcha MD;De Silva T;Uneri A;Jacobson MW;Goerres J;Kleinszig G;Vogt S;Wolinsky JP;Siewerdsen JH
• 通讯作者: Siewerdsen JH

Planning, guidance, and quality assurance of pelvic screw placement using deformable image registration.

• DOI: 10.1088/1361-6560/aa954f
• 发表时间: 2017-11-13
• 期刊: Physics in medicine and biology
• 影响因子: 3.5
• 作者: Goerres J;Uneri A;Jacobson M;Ramsay B;De Silva T;Ketcha M;Han R;Manbachi A;Vogt S;Kleinszig G;Wolinsky JP;Osgood G;Siewerdsen JH
• 通讯作者: Siewerdsen JH

Automatic analysis of global spinal alignment from simple annotation of vertebral bodies.

从椎体的简单注释自动分析全局脊柱对齐。

• DOI: 10.1117/1.jmi.7.3.035001
• 发表时间: 2020
• 期刊: Journal of medical imaging (Bellingham, Wash.)
• 作者: Doerr,SophiaA;DeSilva,Tharindu;Vijayan,Rohan;Han,Runze;Uneri,Ali;Ketcha,MichaelD;Zhang,Xiaoxuan;Khanna,Nishanth;Westbroek,Erick;Jiang,Bowen;Zygourakis,Corinna;Aygun,Nafi;Theodore,Nicholas;Siewerdsen,JeffreyH
• 通讯作者: Siewerdsen,JeffreyH

A mobile isocentric C-arm for intraoperative cone-beam CT: Technical assessment of dose and 3D imaging performance.

• DOI: 10.1002/mp.13983
• 发表时间: 2020-03
• 期刊: Medical physics
• 影响因子: 3.8
• 作者: Sheth NM;De Silva T;Uneri A;Ketcha M;Han R;Vijayan R;Osgood GM;Siewerdsen JH
• 通讯作者: Siewerdsen JH