Research Project
6990444
[unreadable] DESCRIPTION (provided by applicant): Currently there is no non-invasive technology for routine clinical measurement of cardiac output (CO) for more than 30,000 neonates and children needing extracorporeal life support (ECLS) each year. Clinicians treating these patients invariably need to assess the cardiac function at the end of bypass surgery and prior to weaning the patient from extracorporeal membrane oxygenation (ECMO), to quantitatively evaluate the effectiveness of the therapy. [unreadable] [unreadable] Through this proposal, Transonic Systems will address this serious concern by developing a unique non-invasive device that can routinely measure CO and VV ECMO recirculation in critically ill pediatrics undergoing ECLS treatment. This device would help clinicians in the crucial decision making of whether or not to take the patient off the ECLS. [unreadable] [unreadable] Dilution based CO measurements would be performed in bypass surgery and VA ECMO while recirculation will be measured during VV ECMO. Using clamp on sensors and injecting innocuous isotonic saline in conjunction with the pre-positioned cannulas eliminate the need for any further surgical invasion and usage of disposables, making the procedure safe and inexpensive. The technology results in quick and accurate measurements, which could improve the efficacy of the therapy and thereby offer a significant saving in the costs of the treatment. The Phase-l research will demonstrate feasibility via development of prototype clamp-on probes and cardiac output monitor. The Phase-l hardware will be initially evaluated via bench and animal studies, followed by clinical trials at the University of Michigan Medical Center. [unreadable] [unreadable] The Phase-l work will drive a Phase-lI program to design, build, and test highly sensitive steam-sterilizable clamp-on probes, robust software, and a stand-alone cardiac output monitor with an LCD touch screen. Phase-ll clinical studies performed with this hardware will form the basis for a Phase-Ill FDA clearance and manufacturing authorization. The resulting pediatric cardiac output monitor would reduce pediatric morbidity/mortality and the associated health care costs, and would be marketable worldwide in every pediatric hospital that performs heart surgery and/or that has an ECMO program. [unreadable] [unreadable]
