SBIR-STTR Award

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 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 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 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 PROJECT NARRATIVE A bedside noninvasive Cardiac Monitor for venoarterial extracorporeal membrane oxygenation VA ECMO would allow physicians to routinely determine the cardiac status of patients to know when they are ready to be taken off This will help to reduce the serious and fatal complications patients experience due to prolonged time on VA ECMO

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.

Public Health Relevance Statement:
8. PROJECT NARRATIVE A bedside noninvasive Cardiac Monitor for venoarterial extracorporeal membrane oxygenation (VA ECMO) would allow physicians to routinely determine the cardiac status of patients to know when they are ready to be taken off. This will help to reduce the serious and fatal complications patients experience due to prolonged time on VA ECMO.

NIH Spending Category:
Bioengineering; Cardiovascular; Clinical Research; Networking and Information Technology R&D (NITRD); Pediatric

Project Terms:
Algorithmic Software; Algorithms; Animal Model; Animals; base; Blood Volume; Cardiac; Cardiac Output; Cardiopulmonary; Child; Childhood; Clinical Data; Clinical Research; clinical research site; Closure by clamp; Computer software; cost; Data; Data Analyses; data archive; Development; Devices; Early identification; Evaluation; experience; Extracorporeal Membrane Oxygenation; Failure; Generations; Hemolysis; Hemorrhage; in vitro Model; Infant; Infection; Injections; Institutional Review Boards; Laboratory Animal Production and Facilities; Life; Lung; Manuals; mathematical model; Measurement; Measures; Medical center; Medical Device; Methods; Modeling; Modification; Monitor; Morbidity - disease rate; mortality; Movement; Myocardial; neonatal patient; Newborn Infant; Pathology; Patients; Pediatric Hospitals; pediatric patients; Phase; phase 1 study; Philadelphia; Physicians; Preparation; Process; Protocols documentation; prototype; Pulmonary artery structure; Recovery; recruit; Refractory; Reproducibility; research clinical testing; Risk; safety testing; Saline; Savings; sensor; software development; System; Techniques; Technology; Testing; Thrombosis; Time; Tissues; tool; Ultrasonography; Validation; Weaning; Work