COMMERCIALIZATION OF GRAPHICAL INTRAVENOUS DRUG DISPLAY

静脉药物图形显示的商业化

• 批准号: 6883653
• 负责人: NOAH SYROID
• 金额: $ 9.72万
• 依托单位: APPLIED MEDICAL VISUALIZATIONS, LLC
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-04-01 至 2006-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6883653
• 关键词: analgesics; anesthesiology; biomedical equipment development; blood tests; clinical biomedical equipment; clinical research; computer assisted medical decision making; computer assisted patient care; computer graphics /printing; drug interactions; human subject; intravenous anesthesia; patient monitoring device; patient oriented research; pharmacokinetics; sedative /hypnotic

DESCRIPTION (provided by applicant): Applied Medical Visualizations has developed a real-time graphical display showing model-based predictions of drug pharmacology (pharmacokinetics and pharmacodynamics), intended for use by anesthesiologists in the operating room. The administration of intravenous drugs improves when anesthesiologists are able to visualize model-predicted concentrations, effects and interactions due to drug-drug synergism. Preliminary studies have shown significant promise for this technology; time to wake-up after surgery was reduced from 7.5 to 4.5 minutes. However, a clinical validation of the model's accuracy is necessary before developing a commercial product. Our plan is to: Task I: Develop a data collection system for intravenous drug administration in the operating room. Task II: Collect drug administration, vital signs, clinical signs, plasma drug concentrations and bispectral index (BIS) data for 28 patients. Task III: Implement data-parsing and simulation software to predict drug pharmacokjnetic (PK) effect-site concentrations and pharmacodynamic (PD) effects. Task IV: Use the results to refine the drug display's models and measure the accuracy with which the models predict clinical responses (e.g. loss and recovery of responsiveness, vital sign responses to surgical stimuli, EEC (BIS) changes). Phase II: We plan to incorporate additional drug models (premedicatipns, inhalation gases and neuromuscular agents) and evaluate the graphical PKPD display's utility in the operating room. If successfully implemented, the display technology could result in fewer hypertensive and hypotensive episodes, fewer adjuvant drug interventions, a lower incidence of patient movement, a lower incidence of the need for pharmacologic reversal of opioid effect to restore spontanebus ventilation, and more rapid wakeup at the end of surgery. In Phase III, the graphical display technology will be integrated with drug infusion pumps and patient physiologic monitors.

描述（由申请人提供）： Applied Medical Visualizations已开发了一个实时图形显示，显示了基于模型的药物学预测（药代动力学和药效学），该预测旨在在手术室中使用麻醉师。当麻醉学家能够可视化模型预测的浓度，效果和相互作用时，静脉注射药物的给药会改善。初步研究表明了这项技术的巨大希望。手术后醒来的时间从7.5分钟减少到4.5分钟。但是，在开发商业产品之前，必须对模型的准确性进行临床验证。我们的计划是： 任务I：为手术室中静脉药物管理的数据收集系统开发。 任务II：为28名患者收集药物管理，生命体征，临床体征，血浆药物浓度和双光谱指数（BIS）数据。 任务III：实施数据范围和仿真软件来预测药物药物（PK）效应位点浓度和药效学（PD）效应。 任务IV：使用结果来完善药物显示模型并衡量模型预测临床反应的准确性（例如，响应能力的丢失和恢复，对手术刺激的生命体征反应，EEC（BIS）变化）。 第二阶段：我们计划合并其他药物模型（premedicatipn，吸入气体和神经肌肉剂），并在手术室中评估图形PKPD显示器的实用性。 如果成功实施，则显示技术可能会导致高血压和降压性发作，辅助药物干预措施较少，患者运动的发生率较低，阿片类药物效应的需要较低的发生率以及在手术结束时恢复Spontarebus pertical效应以及更快的唤醒。在第三阶段，图形显示技术将与药物输注泵和患者生理监测器集成。