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Case Study #8: C-COM

Clincial Trials & Commercialisation of a Novel Non-Invasive Continuous Cardiac Output (CO) Monitor

C-COM was conceived by an Australian anaesthetist with more than 40 years expertise in anaesthesia and neonatology in Australia; whose previous innovations include the incorporated CPAP system that is now the universal treatment for obstructive sleep apnoea.

C-COM Applications:
- Rapid diagnostics
- Tele-health
- Sports medicine
- AI-assisted diagnostics (future)

About C-COM

Monitoring cardiac output (CO), which is measured in litres/minute, is a common practice in anaesthesia and critical care. It is used as a marker of oxygen delivery to tissues and organs and can identify patients at high risk of significant morbidity, mortality or both, by highlighting issues that blood pressure, blood oxygen saturation and heart rate measurements alone can’t accurately predict.

However, while it is used in guiding treatments such as fluid resuscitation and the use of vasoactive and inotropic drugs, reliably and accurately measuring CO continuously and in real-time has proven highly problematic. Further, the devices able to most accurately determine CO have their own inherent risks; specifically that patients most likely to benefit from having accurate, continuous CO readings available are often the people most at risk from the highly invasive procedures required to obtained the data. The result is that the application of CO monitoring is generally limited to the most acutely ill patients considered to be at the highest risk of morbidity and/or mortality, because clinicians have few other choices.

Additionally, the high skill levels required in using these highly invasive techniques to obtaion accurate CO data, limit its applications, despite its utility being applicable to so many aspects of patient management, primarily the timely determination of optimal treatments for avoiding complications and reducing mortality, whether arising from sepsis, ARDS or complications arising from COVID-19.

The current (as of July 2020) project, which entails 'productionising' C-COM and taking it through clinical trials and to market, seeks to position C-COM as the preferred CO monitoring tool in a much broader range of diagnostics applications.

The clinical value of continuous, accurate CO measurement

The clinical value of accurately monitoring CO is widely understood by anaesthetists and intensivisits. Research by Shoemaker et al in the 1990s revealing that protocols involving aggressively intervening to increase oxygen delivery by manipulating cardiac output (CO) in the peri-operative period resulted in a marked improvement in the post-operative outcomes of high-risk patients.

Further studies by the son of the inventor, Dr David Campbell, revealed that many post-operative complications originated from unrecognised low cardiac output (CO) states during anaesthesia and in the early hours following surgery, and modified his own clinical practice accordingly. He spent over a year of his anaesthetics training working in Intensive Care Units and gained familiarity with the significant difficulties encountered with the use of invasive Cardiac Output monitors in the peri-operative period.

How C-COM works - and why it's unique

  • Optical based sensing
  • C-COM uses optically-derived data to accurately and reliably determine cardiac output (CO).

  • Very simple to use
  • Unlike most other CO devices, C-COM can be set up in seconds by clinicians with minimal training.

    Additionally, a simple, customisable UI able to show mutiple metrics simulataneously, as well as trends, makes C-COM ideal for a broad range of applications, from patient assessment prior to admission, through surgery under anaesthiesia, to critical and intensive care applications under anaesthesia.

  • No electrical or infection risk
  • C-COM poses no electrical or infection risk to patients, so can be used on seriously ill patients, where other CO devices might pose acceptable morbidity or martality risks.

  • Reliable, low-cost, fully integrated, portable
  • C-COM is the only CO monitor known to be able to perform all these functions in a compact, portable, non-invasive and simple-to-use device that requires minimal training to use.

  • Multi-metric monitoring
  • C-COM continuously displays the following:
    - Peak Arterial Flow (l/min)
    - Stroke Volume (ml or litres)
    - Systemic Vascular Resistance (dynes-sec/cm5)
    - Mean Arterial Pressure (mm Hg)
    - Pulse Rate (beats/min)

  • Includes Arterial Compliance
  • C-COM is the only CO monitor known to be able to measure Arterial Compliance, or elasticity (C), which is the change in arterial blood volume (ΔV) due to a given change in arterial blood pressure (ΔP). It is another valuable metric in determining cardiopulmonary performance and assessing appropriate, timely treatments during anaesthesia.

  • And Dissolved Oxygen (DO2) measurement
  • C-COM is the only CO monitor known to be able to measure dissolved oxygen, the technique for which is covered by the second of the two patents underpinning the C-COM concept.

  • Local or remote monitoring
  • Being a connected device, C-COM's outputs can be not only be monitored at the patient's bedside, but remotely; for example, from a nurse's station outside of an infectious patients' ward, or by a healthcare professional monitoring a patient at home or in a medi-hotel.

    The problems with accurately, continuously measuring CO

  • Accuracy vs Applicability
  • Cardiac MRI machinjes offer the most accurate method for determining CO, however, aren't applicable tools for patients under anaesthesia in theatre or ICU.

    And Swan-Ganz cathetorisation methods are highly invasive, highly risky, can’t be used in certain situations and only provide instantaneous CO measurements, not continuous.

    C-COM provides accuracy without the risks arising associated with invasive devices.

  • Continuous vs Instantaneous measurement techniques
  • Non-invasive techniques such as ECGs and cardiac MRIs can provide continuous measurements of CO over a period of time, but are generally limited with respect to the duration of time they can provide a continuous measurement of CO.

    And invasive techniques such as Swan Ganz cathetorisation might be relatively accurate, but only provide instantaneous readings, or readings over relatively short periods of time, which may be insifficient to determine trends or detect sudden undesirable changes in CO.

    C-COM provides continuous, real-time measurements and determines trends over time.

  • Instantaneous Blood Pressure (BP) measurement
  • While non-invasive, BP is typically only instantaneous, as well as unreliable in determining perfusion (or the rate of oxygenated blood delivered per unit mass of tissue), as large changes in cardiac output may occur with little effect on blood pressure.

    C-COM also provides BP measurements.

  • Pulse Contour Analysis (PCA) methods
  • While non-invasive, PCA does not measure two of the critical metrics for reliably determining Cardiac Output, specifically:
    - Mean Arterial Pressure (BP) and
    - Systemic Vascular Resistance (SVR)

    C-COM provides these metrics, as well as DO2, Arterial Compliance and a range of others - in fact, more than any other CO monitor on the market.

  • Other non-invasive monitoring methods
  • While non-invasive, the following are unsatisfactory because of accuracy issues or their inability to provide continuous monitoring of a broad range of metrics:
    - Transcutaneous Doppler
    - Transthoracic Bio-Impedance

    Once connected to a patient, C-COM does not require an operator. Any clinician can read the outputs, both locally and (future option) remotely via a centralised app (eg at a remote nurse's station).

  • Other Invasive monitoring methods
  • - Thermo-dilution (using Swan-Ganz catheterisation)
    - Oesophageal Doppler (eg Deltex CardioQ) which involves insertion of a Doppler device down the trachea
    - Lithium injection, which is non-continuous
    - Dye dilution, which is also non-continuous and only suitable for a once-only use per patient

    C-COM entails no electrical or infection risk to either patient or operator because it is entirely non-invasive.

    Trials & Commercialisation

  • Staged Clinical Trials
  • Amatek has engaged with a leading clinical trials management organisation and secured 'in principal' participation from two leading hospitals to undertake accuracy, reliability, utility and safety trials.

  • Commercialisation
  • Amatek has developed new system architecures for both hardware and firmware, as well as devised new software concepts that hope to make C-COM the most utilitarian AND accurate CO device available.

    Plus, we're exploring local manufacturing opportunities with ISO13485 certified manufacturers to ensure this 100% Australian concept becomes an Australian, and a global, success.

    Helping innovative people create AMAZING!