Automated Intravenous Anesthesia Delivery to Improve Outcome in Children-TIVAPeds

Neurowave Systems, Inc., Cleveland Heights OH

Investigators

Abstract

DESCRIPTION (provided by applicant): Total intravenous anesthesia (TIVA) in children offers significant improvement in outcomes in comparison to inhaled anesthesia that is predominantly used in the developed world. For example, it has been shown that TIVA results in a two-and-a-half fold reduction in emergence delirium (ED), which refers to a variety of behavioral disturbances commonly seen in children following emergence from anesthesia. ED can predispose children to lasting memory impairment and maladaptive behavior development. The incidence of ED in pediatric anesthesia procedures using inhaled agents may be as high as 40% and is highest in children aged 2-6 years. However, despite its important benefits, TIVA is not widely used since this technique is quite difficult to administer manually. This is due to the lack of a direct measure of drug concentration in the blood, and due to the need for constant adjustments in drug infusion rate. This program will address this problem by performing a feasibility study regarding outcomes of the TIVAPedsTM device for automated delivery of TIVA in children, based on noninvasive measurements of their brain activity. The overall goal of this Phase I am to explore whether it is possible to achieve improved outcomes associated with TIVA by using the TIVAPeds system. The Specific Aims of this 2-year Phase I program include collection and analysis of clinical data in children at two clinical institutions. At the first insitution, data will be collected from 20 children undergoing TIVA delivered by the TIVAPeds closed-loop system using our NeuroSENSE depth-of-anesthesia monitor. This system has already received Federal (Health Canada) and institution's Research Ethics Board approval, and has been successfully used in prior clinical studies involving pediatric patients. The second institution wil collect data from children receiving inhaled anesthesia, delivered using standard clinical practice. The data from the two study arms will be compared and analyzed to assess differences in outcome measures. Results will be used for the design of a pivotal clinical study protocol, for demonstrating safety and efficacy of the TIVAPeds system during the Phase II effort. The ultimate objective is to commercialize the TIVAPeds device in order to enable wider use of TIVA and bring its benefits to a large number of pediatric patients.