# Cardiac Monitor for VA ECMO Pediatric and Neonatal Patients

> **NIH NIH R44** · TRANSONIC SYSTEMS, INC. · 2020 · $714,784

## Abstract

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.

## Key facts

- **NIH application ID:** 9994993
- **Project number:** 5R44HL136008-03
- **Recipient organization:** TRANSONIC SYSTEMS, INC.
- **Principal Investigator:** Nikolai M Krivitski
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $714,784
- **Award type:** 5
- **Project period:** 2017-07-01 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9994993

## Citation

> US National Institutes of Health, RePORTER application 9994993, Cardiac Monitor for VA ECMO Pediatric and Neonatal Patients (5R44HL136008-03). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/9994993. Licensed CC0.

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