MODULATED IMAGINING OF TISSUE TRANSFER FLAPS

组织转移皮瓣的调制成像

• 批准号: 8362640
• 负责人: ANTHONY J DURKIN
• 金额: $ 1.87万
• 依托单位: UNIVERSITY OF CALIFORNIA-IRVINE
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-04-01 至 2012-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8362640
• 关键词: Animal Model; Animals; Biotechnology; Blinded; Blood Vessels; Blood flow; Caring; Classification; Clinical; Clinical Research; Complication; Data; Detection; Development; Devices; Diffuse; Diffusion; Early Diagnosis; Early treatment; Edema; Epigastric; Family suidae; Forearm; Functional disorder; Funding; Goals; Grant; Hemoglobin; Image; Institutes; Intervention; Ischemia; Laboratories; Lasers; Liquid substance; Literature; Methodology; Modeling; Monitor; National Center for Research Resources; Nature; Necrosis; Operative Surgical Procedures; Optics; Oxygen; Patients; Perfusion; Postoperative Period; Principal Investigator; Prospective Studies; Protocols documentation; Publishing; Radial; Randomized; Rattus; Reconstructive Surgical Procedures; Reperfusion Therapy; Reporting; Research; Research Design; Research Infrastructure; Research Project Grants; Resources; Sensitivity and Specificity; Signal Transduction; Skin; Source; Spectrum Analysis; Surgical Flaps; Technology; Thrombosis; Tissues; United States National Institutes of Health; Venous; Venous Thrombosis; Work; animal model development; cost; design; improved; interstitial; maxillofacial; monitoring device; outcome forecast; reconstruction; research study; tissue oxygenation

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. Primary support for the subproject and the subproject's principal investigator may have been provided by other sources, including other NIH sources. The Total Cost listed for the subproject likely represents the estimated amount of Center infrastructure utilized by the subproject, not direct funding provided by the NCRR grant to the subproject or subproject staff. Background & Purpose of Research Goals The goal of this proposed research project is to develop a protocol that would involve work already underway at the Beckman laser institute, using Diffuse Optical Spectroscopy (DOS) to evaluate changes in tissue transfer flaps. This project would build on the current animal studies investigating a pedicle skin flap model. The DOS device, developed at the Beckman Laser Institute in conjuncture with a partnership with Modulated Imaging Inc., allows for spatial determination of hemoglobin concentrations [Hb], degree of tissue oxygenation, and edema. This information and changes in the valves have been shown by other groups as means to monitor tissue transfer flaps and has been shown to precede changes noted clinically, thereby allowing for earlier detection of vascular compromise, and early intervention. This project proposes the development of a pig free flap animal model as well the development of a clinical research project that would use Modulated Imaging to monitor both pedicle and free flaps in the para-operative period in patients undergoing reconstructive surgery. The major goal would be to demonstrate that the use of this device allows for the early detection, differentiation between arterial and venous thrombosis, and thereby allows for early intervention and improved salvage rates in vascular compromised flaps. Laboratory & Clinical Background Thrombosis of either an arterial or venous nature is a major complication after tissue transfer in reconstructive surgery. It is known that generally venous thrombosis has a worse out-come, when compared to arterial thrombosis after reestablishment of blood flow, due to differences in the pathophysiology involved in venous congestion of the tissue and impaired oxygen delivery after reperfusion. The fact that venous thrombosis is more difficult to detect early may also contribute to the poor prognosis with venous thrombosis. Studies have shown that frequent monitoring of flaps allows for early detection of vascular thrombosis and thereby allows for early operative re-exploration, and improved salvage rates after vascular compromise. Free flap thrombosis rates requiring re-exploration have been reported in the literature as 5-10%, with flap loss rates reported as 3-5%, and post-operative thrombosis salvage rates have been reported as ranging from 40-69%. Several authors have emphasized that one of the keys to improving the salvage rate after graft thrombosis is frequent monitoring, in the early post-operative period, thus allowing for early recognition, and intervention, including operative re-exploration. Hjortdal et al. using a pig model demonstrated increased tissue necrosis after re-perfusion due to venous congestion compared to arterial ischemia, this is thought to be due to increased tissue fluid (i.e. venous congestion / edema) associated with venous thrombosis, which inhibits diffusion of oxygen through the interstitial space to the tissue. Payette et al. showed in an article published in Feb. 2005, that spectroscopy was more consistently reliable when compared to laser Doppler in detecting arterial flow problems in rat animal models, using both an epigastric free flaps model as well as a pedicle skin flap model (reverse McFarlane flap). Wolff et al. in 2006 reported using a single device that used spectroscopy in combination with laser Doppler flow to detect vascular complications prior to clinically evident changes in the tissue flaps, and was able to reliably distinguish between venous and arterial thrombosis, in patients undergoing maxillofacial reconstruction with a fasciocutaneous radial forearm free flaps. The use of DOS technology developed at the Beckman Laser Institute in conjuncture with Modulated Imaging Inc. may provide a useful technology in monitoring both pedicle and free tissue transfer flaps in the para-operative during the first 2-3 days after surgery when a majority of arterial and venous thrombosis occur. This monitoring of flaps using DOS may allow for early detection, and classification of vascular compromise prior to clinically evident changes, thereby improving salvage rates and thus cost in patients undergoing reconstructive surgery. Proposed Methodology Four part to study design, including: 1. Development of an animal model with both pedicle and free flaps designed to determine the changes in the [Hb], oxygen concentration, and tissue edema that would allow for a DOS device to reliably determine arterial vs. venous thrombosis, with reasonable sensitivity and specificity. 2. Develop a randomized, blinded study in which clinical observation is compared to application of a DOS device, in the detection of arterial and venous thrombosis, in an animal model. 3. Develop an experiment to determine if early detection of venous thrombosis using a DOS monitoring device, (prior to clinical detection) and reperfusion allows for improves salvage rates in flaps after venous thrombosis in an animal flap model. 4. Development of a prospective study that would collect data from patients undergoing both pedicle and free flaps designed to monitor tissue in the near post-operative period using both classical clinical monitoring in the ICU including conventional arterial Doppler signals, and as well as monitoring using a DOS device. This would be done during the first three days post-operatively, or until the patient is transferred out of an ICU level of care if done prior to post-operative day number 3.

该子项目是利用 NIH/NCRR 资助的中心拨款提供的资源的众多研究子项目之一。对子项目和子项目主要研究者的主要支持可能是由其他来源提供的，包括其他 NIH 来源。 子项目列出的总成本可能代表子项目使用的中心基础设施的估计金额，而不是 NCRR 拨款向子项目或子项目工作人员提供的直接资金。 研究背景及目的 目标 该拟议研究项目的目标是制定一项协议，其中涉及贝克曼激光研究所已经开展的工作，使用漫反射光谱 (DOS) 来评估组织转移皮瓣的变化。 该项目将建立在当前研究带蒂皮瓣模型的动物研究的基础上。 DOS 设备是贝克曼激光研究所与 Modulated Imaging Inc. 合作开发的，可以对血红蛋白浓度 [Hb]、组织氧合程度和水肿进行空间测定。 其他小组已将这些信息和瓣膜的变化作为监测组织转移皮瓣的手段，并已证明其先于临床注意到的变化，从而可以更早地检测血管受损并进行早期干预。 该项目建议开发猪游离皮瓣动物模型，并开发一个临床研究项目，该项目将使用调制成像技术来监测接受重建手术的患者在术前期间的蒂和游离皮瓣。 主要目标是证明该装置的使用可以早期检测、区分动脉和静脉血栓形成，从而可以进行早期干预并提高血管受损皮瓣的抢救率。 实验室和临床背景 动脉或静脉血栓形成是重建手术中组织转移后的主要并发症。 众所周知，与血流重建后的动脉血栓相比，静脉血栓通常具有更差的结果，这是由于组织静脉充血和再灌注后氧输送受损所涉及的病理生理学差异。 静脉血栓较难早期发现这一事实也可能导致静脉血栓的预后不良。 研究表明，频繁监测皮瓣可以及早发现血管血栓形成，从而可以及早进行手术重新探查，并提高血管受损后的抢救率。 文献报道需要重新探查的游离皮瓣血栓形成率为 5-10%，皮瓣丢失率为 3-5%，术后血栓挽救率据报道为 40-69%。 几位作者强调，提高移植物血栓后抢救率的关键之一是在术后早期进行频繁监测，从而实现早期识别和干预，包括手术重新探查。 约特达尔等人。使用猪模型证明，与动脉缺血相比，由于静脉充血，再灌注后组织坏死增加，这被认为是由于与静脉血栓形成相关的组织液增加（即静脉充血/水肿），这抑制了氧气通过组织间隙扩散到组织。 帕耶特等人。在 2005 年 2 月发表的一篇文章中表明，与激光多普勒相比，在使用上腹游离皮瓣模型和带蒂皮瓣模型（反向麦克法兰皮瓣）检测大鼠动物模型的动脉血流问题时，光谱学更加可靠。 沃尔夫等人。 2006 年报道，在使用前臂筋膜皮肤桡侧游离皮瓣进行颌面重建的患者中，使用单一设备，将光谱学与激光多普勒血流相结合，在组织瓣发生临床明显变化之前检测血管并发症，并能够可靠地区分静脉血栓和动脉血栓。 Beckman Laser Institute 与 Modulated Imaging Inc. 联合开发的 DOS 技术的使用可能会提供一种有用的技术，用于在术后 2-3 天内监测术中的蒂和游离组织转移皮瓣，此时大部分动脉和静脉血栓都会发生。 使用 DOS 对皮瓣进行监测可以在临床明显变化之前进行早期检测和对血管损害进行分类，从而提高挽救率，从而提高接受重建手术的患者的成本。 提议的方法 研究设计的四个部分，包括： 1. 开发带有蒂和游离皮瓣的动物模型，旨在确定 [Hb]、氧浓度和组织水肿的变化，从而使 DOS 装置能够可靠地确定动脉与静脉血栓形成，并具有合理的灵敏度和特异性。 2. 开展一项随机、盲法研究，将临床观察与 DOS 装置在动物模型中检测动脉和静脉血栓形成的应用进行比较。 3. 开展一项实验，以确定使用 DOS 监测装置（在临床检测之前）早期检测静脉血栓形成和再灌注是否可以提高动物皮瓣模型中静脉血栓形成后皮瓣的抢救率。 4. 开展一项前瞻性研究，收集接受带蒂皮瓣和游离皮瓣的患者的数据，旨在使用 ICU 中的经典临床监测（包括传统的动脉多普勒信号）以及使用 DOS 设备的监测来监测术后不久的组织。 这将在术后前三天内完成，或者如果在术后第 3 天之前完成，则直到患者转出 ICU 护理级别。