Research Project
9572642
7. PROJECT SUMMARY/ABSTRACT Venoarterial Extracorporeal Membrane Oxygenation (VA ECMO) is a way to provide cardiac and pulmonary support to patients without other alternatives. This form of life support is vital to pediatric and neonatal patients. As with any life support, there are serious complications that occur. These complications including bleeding, thrombosis, and infection become more frequent the longer a patient is on ECMO. Therefore a method that would allow physicians to determine the cardiac status of these patients to know when to take them off VA ECMO would be very valuable. The long term objective of this project is to provide the first noninvasive bedside Cardiac Monitor for automatic/manual cardiac output and blood volume assessment for VA ECMO pediatric and neonatal patients. Unlike existing technology, this device will be allow for frequent measurements and will be suitable for use on infants and children. This device will consist of two ultrasound sensors that get clamped onto the ECMO tubing. Measurements are made by injecting saline into the ECMO circuit. Cardiac output and blood volume measurements are calculated using the ultrasound dilution curves produced. These values will be displayed on a monitor for the physician to see and determine the appropriate course of action for the patient. Based on preliminary work and the prototype software, algorithms for determining cardiac output and blood volume will be tested in an in-vitro model. Animal studies will be performed on 6-8 newborn lambs at the Animal Research Facility at Children?s National Medical Center to compare measurement techniques to be used to optimize the software. Phase I work will end with a preliminary study on 4-8 patients to collect feasibility data. In preparation for the clinical study in Phase II, necessary modifications will be made to the software and hardware. Clinical testing will be performed at the Children?s National Medical Center and the Children?s Hospital of Philadelphia on 40-48 neonatal and pediatric patients on VA ECMO. With the data acquired through clinical testing, the software will be optimized to yield highly accurate and reproducible measurements. Finally, preparation will begin for submission to the FDA for medical device clearance.
