Commercialization of a Graphical Pharmacokinetic-Pharmacodynamic Display

图形药代动力学-药效显示的商业化

• 批准号: 7354104
• 负责人: NOAH SYROID
• 金额: $ 35.98万
• 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 2010-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7354104
• 关键词: Absence of pain sensation; Accounting; Adjuvant; Adverse effects; Analgesics; Anesthesia procedures; Anesthetics; Antihypertensive Agents; Behavior; Breathing; Caring; Certified registered nurse anesthetist; Clinical; Clinical Research; Complex; Conscious; Development; Dose; Drug Combinations; Drug Interactions; Drug Kinetics; Drug Synergism; Elderly; End Point; Ensure; Environment; Environmental air flow; Evaluation; Fentanyl; Future; Gases; General anesthetic drugs; Hemorrhage; Human Volunteers; Hypnotics and Sedatives; Imagery; Incidence; Infusion procedures; Intelligence; Intervention; Intravenous; Isoflurane; Knowledge; Laryngoscopy; Measures; Medical; Methods; Modeling; Movement; Numbers; Obesity; Operating Rooms; Operative Surgical Procedures; Opioid; Patient Care; Patient Schedules; Patients; Performance; Pharmaceutical Preparations; Pharmacodynamics; Phase; Population; Probability; Propofol; Provider; Rate; Recovery; Risk; Sedation procedure; Stimulus; Study models; Sufentanil; Surface; Techniques; Time; Titrations; Unconscious State; Update; Ventilatory Depression; Visual; Work; base; commercialization; desflurane; design; desire; experience; interest; remifentanil; repository; response; sedative; sevoflurane; usability

DESCRIPTION (provided by applicant): Applied Medical Visualizations L.L.C. has developed a pharmacokinetic-pharmacodynamic display (PkPd Display) intended for anesthesia care providers. In Phase I, we designed a display that was based on a two drug interaction model, which was previously developed for an opioid (remifentanil) and a sedative hypnotic (propofol) in human volunteers. The measures for this PkPd interaction model include the probability of loss of consciousness and loss of response to various noxious stimuli. The model was evaluated in the operating room on its ability to predict loss and regain of consciousness and to predict non-responsiveness to noxious stimuli in a wide variety of patients. The results were positive. The models adequately predicted clinical endpoints of interest to an anesthetist and is hence, commercially viable. For Phase II, several aspects of the PkPd Display merit development and further evaluation prior to commercialization: 1. we will evaluate the usability of the PkPd Display and ensure it will not interfere with other critical aspects of anesthetic delivery and appropriate patient care. The display will be evaluated in both patient simulator and operating room settings. 2. We will expand the number of interaction models used within the PkPd Display to include other commonly used anesthetics, such as inhaled agents and additional opioids. 3. We will characterize differences in the drug-drug interaction in patients scheduled for elective surgery who chronically consume opioids, and update the PkPd Display with these results 4. We will implement optimization techniques so that the display's models predict drug combinations that will result in a rapid wakeup by the patient while maintaining adequate analgesia during recovery. If successfully implemented, use of the PkPd Display 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 spontaneous ventilation, and more rapid wakeup at the end of surgery. By generalizing the PkPd models for use with inhaled agents and opioids, the display will be usable in a significantly larger portion of administered anesthetics worldwide. By accounting for additional model covariates, such as the opioid tolerant patient, the display can provide accurate predictions for outliers beyond the normal population, possibly reducing risk of respiratory depression and inadequate analgesia. Optimizing the display will bring intelligence into the display, providing complex optimizations with a simple presentation to the user. 7. PROJECT NARRATIVE Applied Medical Visualizations L.L.C. has developed a graphical drug display intended for anesthesia care providers. This display is intended to help anesthesiologists visualize a patient's level of sedation and analgesia during surgery, resulting in more effective anesthetics and less episodes of inadequate analgesia experienced by the patient.

描述（申请人提供）：应用的医疗可视化L.L.C.已经开发了用于麻醉护理提供者的药代动力学表现（PKPD显示）。在第一阶段，我们设计了一个基于两个药物相互作用模型的显示，该模型先前是为阿片类药物（雷利菲恩尼）和人类志愿者中的镇静性催眠（丙泊酚）开发的。这种PKPD相互作用模型的措施包括意识丧失的可能性以及对各种有害刺激的反应丧失。该模型在手术室中评估了其预测意识丧失和恢复的能力，并预测各种患者对有害刺激的无反应性。结果为正。这些模型充分预测了麻醉师感兴趣的临床终点，因此在商业上可行。对于第二阶段，PKPD的几个方面显示出值得开发和商业化之前的进一步评估：1。我们将评估PKPD显示的可用性，并确保它不会干扰麻醉剂的其他关键方面和适当的患者护理。该显示器将在患者模拟器和手术室设置中进行评估。 2。我们将扩大PKPD显示内使用的交互模型的数量，以包括其他常用的麻醉药，例如吸入剂和其他阿片类药物。 3。我们将表征计划进行选修手术的患者中药物相互作用的差异，这些患者长期食用阿片类药物，并使用这些结果更新PKPD显示4。我们将实施优化技术，以预测显示器的药物组合，从而在恢复过程中维持可恢复型镇痛的同时迅速唤醒。如果成功实施，使用PKPD显示器可能会导致高血压和降压发作，辅助药物干预措施较少，患者运动的发生率较低，阿片类药物效应的发生率较低，以恢复自发性频道的效果以及在手术进行的迅速唤醒。通过将PKPD模型概括为与吸入剂和阿片类药物一起使用，该显示器将在全球范围内的大部分管理麻醉剂中可用。通过考虑其他模型协变量，例如阿片类药物耐受性患者，该显示可以为超越正常人群以外的异常值提供准确的预测，从而减少呼吸抑郁症和镇痛不足的风险。优化显示屏将使智能进入显示屏，并为用户提供简单的演示文稿提供复杂的优化。 7。项目叙事应用医学可视化L.L.C.已经开发了用于麻醉护理提供者的图形药物显示。该显示旨在帮助麻醉师在手术过程中可视化患者的镇静和镇痛水平，从而导致更有效的麻醉药和患者经历的镇痛不足发作。

项目成果

Response surface model predictions of emergence and response to pain in the recovery room: An evaluation of patients emerging from an isoflurane and fentanyl anesthetic.

反应面模型预测恢复室中的苏醒和对疼痛的反应：对异氟烷和芬太尼麻醉后苏醒的患者进行评估。

• DOI: 10.1213/ane.0b013e3181b11289
• 发表时间: 2010
• 期刊: Anesthesia and analgesia
• 影响因子: 5.7
• 作者: Syroid,NoahD;Johnson,KenB;Pace,NathanL;Westenskow,DwayneR;Tyler,Diane;Bruhschwein,Frederike;Albert,RobertW;Roalstad,Shelly;Costy-Bennett,Samuel;Egan,TalmageD
• 通讯作者: Egan,TalmageD

An evaluation of remifentanil-sevoflurane response surface models in patients emerging from anesthesia: model improvement using effect-site sevoflurane concentrations.

麻醉后患者瑞芬太尼-七氟醚反应面模型的评估：使用效应部位七氟醚浓度改进模型。

• DOI: 10.1213/ane.0b013e3181afe31c
• 发表时间: 2010
• 期刊: Anesthesia and analgesia
• 影响因子: 5.7
• 作者: Johnson,KenB;Syroid,NoahD;Gupta,DhaneshK;Manyam,SandeepC;Pace,NathanL;LaPierre,CrisD;Egan,TalmageD;White,JuliaL;Tyler,Diane;Westenskow,DwayneR
• 通讯作者: Westenskow,DwayneR