Wireless Pulse Oximetry (WiPOX) for Diagnosing Intra-Operative Ischemia

用于诊断术中缺血的无线脉搏血氧仪 (WiPOX)

• 批准号: 8702683
• 负责人: MAROM BIKSON
• 金额: $ 7.65万
• 依托单位: CITY COLLEGE OF NEW YORK
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-04-01 至 2016-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8702683
• 关键词: Algorithmic Software; Algorithms; Amendment; Anastomosis - action; Animals; Biomedical Engineering; Blood; Blood flow; Cities; Clinical; Clinical Trials; Collaborations; Complex; Coronary Artery Bypass; Data; Development; Devices; Diagnosis; Diagnostic; Electronics; Engineering; Ensure; Esophageal; Esophagectomy; Excision; Extravasation; Feedback; Fingers; Hand; Head; Healed; Hospitalization; Hospitals; Human; IACUC; Institutional Review Boards; Intention; Intraoperative Monitoring; Ischemia; Joints; Malignant neoplasm of esophagus; Measurement; Measures; Mechanics; Memorial Sloan-Kettering Cancer Center; Methods; Modification; Monitor; Morbidity - disease rate; Morphologic artifacts; Motion; New York; Noise; Operating Rooms; Operative Surgical Procedures; Organ; Organ Transplantation; Outcome; Output; Oxygen saturation measurement; Patients; Performance; Peripheral; Physiologic pulse; Plastic Surgical Procedures; Postoperative Period; Preclinical Testing; Process; Protocols documentation; Pulse Oximetry; Pulse Rates; Reading; Relative (related person); Safety; Site; Solid; Speed; Surgeon; Surgical Flaps; System; Tactile; Techniques; Testing; Therapeutic Intervention; Time; Tissue Viability; Tissues; Touch sensation; Training; Validation; Visual; Wireless Technology; Work; Writing; base; college; cost; design; design and construction; healing; improved; innovation; instrument; meetings; minimally invasive; mortality; novel; operation; optical sensor; preclinical study; pressure; prevent; public health relevance; reconstruction; research clinical testing; sensor; signal processing; tissue oxygenation; tool; transmission process; user-friendly; wound

DESCRIPTION (provided by applicant): Tissue ischemia is a major cause of wound dehiscence or anastomotic leakage resulting in significant morbidity and mortality and occurs at a rate of 15 to 25%. Although measurement of systemic blood oxygenation status by pulse oximetry on the finger is a mandatory requirement for every single patient while in the hospital, there are no devices or methods available to measure tissue oxygenation following complex surgical resections and reconstructions in the operating room. Increasingly, surgical procedures are performed by minimally invasive techniques, which add complexity to the problem, as surgeons do not have the opportunity to directly touch, feel or visualize the organs. In a collaboration between The City College of New York (CCNY) bioengineering design team and Memorial Sloan-Kettering Cancer Center (MSKCC) surgeons, we have successfully designed, constructed and tested a novel wireless, handheld intraoperative oximetry (WiPOX) device, which provides real-time, accurate, and convenient intraoperative monitoring of the tissue oxygenation ensuring tissue viability thereby improving surgical outcomes, decreasing mortality, patient hospitalization and the associated costs. In this R03 proposal, based on the feedback from the ongoing clinical trial, we will enhance device performance and accuracy through two further innovations: incorporation of onboard pressure sensors to allow reliable tissue contact and enhancement of S/N through wireless integration with a systemic pulse oximeter. A pipeline for preclinical and clinical testing is in place. These innovative modifications are crucial for surgeons to take the next step of this device utility - to modify the surgical procedure based on tissue oxygenation.

描述（由申请方提供）：组织缺血是伤口裂开或吻合口瘘的主要原因，导致显著的发病率和死亡率，发生率为15 - 25%。虽然通过脉搏血氧仪测量手指上的全身血氧状态是每个患者在医院中的强制性要求，但在手术室中进行复杂的手术切除和重建后，没有可用于测量组织氧合的设备或方法。越来越多的外科手术是通过微创技术进行的，这增加了问题的复杂性，因为外科医生没有机会直接触摸，感觉或可视化器官。在纽约（CCNY）生物工程设计团队和纪念斯隆-凯特琳癌症中心（MSKCC）外科医生之间的合作中，我们成功地设计、构建和测试了一种新型无线手持式术中血氧测定（WiPOX）设备，该设备提供实时、准确和方便的术中组织氧合监测，确保组织活力，从而改善手术结果，降低死亡率，患者的住院治疗和相关费用。在本R 03提案中，基于正在进行的临床试验的反馈，我们将通过两项进一步的创新来提高器械性能和准确性：纳入板载压力传感器，以实现可靠的组织接触，并通过与全身脉搏血氧仪的无线集成来增强S/N。临床前和临床试验的管道已经到位。这些创新性的改进对于外科医生采取该器械实用性的下一步至关重要-基于组织氧合来修改外科手术。