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.

Public Health Relevance

Total intravenous anesthesia (TIVA) in children offers significant improvement in outcomes in comparison to commonly used inhaled anesthesia such as way less emergence delirium, which can predispose children to lasting memory problems and affect their behavior development. However, TIVA is quite difficult to manually administer and thus is not widely used. This program will perform a feasibility study regarding the benefits of the TIVAPedsTM device for automated delivery of TIVA in children, based on noninvasive measurements of their brain activity.

Agency
National Institute of Health (NIH)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
1R43GM112358-01
Application #
8782013
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Cole, Alison E
Project Start
Project End
Budget Start
Budget End
Support Year
1
Fiscal Year
2014
Total Cost
Indirect Cost
Name
Neurowave Systems, Inc.
Department
Type
DUNS #
City
Cleveland Heights
State
OH
Country
United States
Zip Code
44118