COMMERCIALIZATION OF GRAPHICAL INTRAVENOUS DRUG DISPLAY

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.