Benefits

USCOM 1A Validation

INTRODUCTION

The accuracy of the USCOM method has been rigorously proven through numerous independent studies in laboratory testing, in animal studies, beside other methods and in various clinical applications.

USCOM is proven across an extremely broad range of patients. The USCOM device has been validated (Cardiac Output) from 0.12 Litres per minute to 18.5 Litres per minute and from 26 week gestational age (390 grams) to 85 years.

The device has been independently validated against the gold standard flow probe, in precision laboratory testing, against flow probes in animal hearts and Swan Ganz thermodilution in the clinical settings of CCU and heart failure. USCOM has also been validated in the challenging case of patients on ventilation and immediately after cardiac surgery and during exercise.

Flow probes are the laboratory gold standard measure of flow with a quoted absolute accuracy of +/- 2%.

USCOM comparisons with flow probes in computer controlled flow simulators and animal models, at a range of cardiac outputs, have demonstrated a variation of less than 5%.

This agreement suggests USCOM is the most sensitive clinical method of measuring cardiac flow. USCOM has been proven at 5 stages of validation:
  1. Historical evidence of the accuracy and reliability of CW Doppler

  2. Independent laboratory testing of USCOM´s accuracy in measuring flow

  3. Independent assessment of USCOM´s accuracy against flow probes in animals

  4. Independent studies showing USCOM´s agreement with other methods including PAC, Fick, echo and MRI methods

  5. Evidence of USCOM´s usefulness in clinical practice

USCOM studies have been published in 7 leading peer-reviewed Journals; the Annals of Thoracic Surgery, Anesthesia & Analgesia, the British Journal of Anaesthesia, Emergency Medicine Australasia, the American Journal of Emergency Medicine, the Air Medical Journal and the Journal of Cardiothoracic and Vascular Anesthesia.

USCOM is currently participating in research across multiple applications of its technology at multiple clinical centres of excellence in Australia, Asia, Europe and the United States.

USCOM maintains a list of Current Evidence for it's products including Validation material. Refer to the Current Evidence page.