SBIR/STTR Award attributes
7. PROJECT SUMMARY/ABSTRACT Veno-venous Extracorporeal Membrane Oxygenation (VV ECMO) is often a last resort for thousands of patients in need of pulmonary support. This includes patient suffering from lung failure including Acute Respiratory Distress Syndrome (ARDS). Many times, along with ARDS, patients have or develop pulmonary hypertension and/or right ventricle failure especially with prolonged duration of ECMO support. A method to monitor the cardiac status of these patients on VV ECMO to know when low cardiac output is developing and change the treatment strategy would be very valuable. The long-term objective of this project is to provide the first noninvasive bedside ECMO Cardiac Output Monitor for VV ECMO patients of all ages. This will help in routine treatment therapy in intensive care ECMO population known for the highest mortality rate. It will specifically provide early diagnosis of heart failure and help in the early initiation of VA ECMO if heart treatment therapy does not work, thus decreasing morbidity and mortality and cutting costs. 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 at two ECMO pump flows and recording oxygen saturation. Cardiac output is then calculated using the ultrasound dilution curves produced and the entered information. These values will be displayed on a monitor for the physician to see and determine the appropriate course of action for the patient. Initially, software will be developed for the cardiac output calculation after further development of the mathematical model. Animal studies will be performed on 6-8 pigs at SUNY Upstate Medical University. This will be to compare and validate the cardiac output measurement technique and help to optimize the software. Phase I work will end with a preliminary clinical study on 4-8 patients to collect feasibility data at Inova Fairfax Medical Center and SUNY Upstate Medical University.8. PROJECT NARRATIVE A bedside noninvasive accurate method to determine the cardiac status of patients on veno-venous extracorporeal membrane oxygenation (VV ECMO) would allow clinicians to monitor hemodynamics in real- time and adjust patient care accordingly. This will lead to a better understanding of heart-lung interactions and the early identification of low cardiac output both helping to alter the outcome of many of these critically ill patients.
