Project: Development of micro medical analyzer for ammonia monitoring in expiratory gas of critically ill

BACKGROUND_x000D_Ammonia is one of the CO toxic product of hepatic metabolism. It was identified as the CO factor for the hepatic encephalopathy (HE) syndrome. In patients with cirrhosis hepatitis, the reduction of hepatocellular function contribute to increased serum levels of this neurotoxin. HE causes substantial morality and utilization of resources. Brain edema and intracerebral hypertension must be treated emergently and ammonia elimination must be facilitated. Since treatment is focused on ammonia elimination, close monitoring of ammonia production and elimination is necessary. Currently it is performed only by intermittent measuring of ammonia in blood which is time consuming and patient unfriendly. Continuous monitoring of the ammonia level in expiratory gases in critically ill could improve treatment strategies. _x000D__x000D_THE AIM OF THE PROJECT_x000D_The aim of this project is the evaluation of breath ammonia testing and its correlation with blood, urine ammonia levels and with neurological tests. Based on this we will develop a small bed-side breath analysis system for ammonia determination in expiratory gas . Having such analysis system in intensive care units could mean the difference between life and death for critically ill with liver and kidney dysfunctions._x000D_At the moment the analyzer that will be developed in the AMmonia Micro SEns project is the only ammonia determination alternative to blood analysis with huge benefits for critically ill. There are no such analyzers as products on the market although the technology which could also be used for this purpose already exists._x000D_The advantages of the new instrument are:_x000D_1: Real-time monitoring of ammonia levels in critically ill patients._x000D_2: Not-invasive measurements of ammonia levels._x000D_3: Early onset of therapy._x000D__x000D_MARKET NEEDS _x000D_The quality of critically ill treatment and survivor rate could drastically improve if tertiary intensive care unit (ICU) would have a breath analyzing system for ammonia determination. Especially, in centres focused on acute liver failure and liver transplantations all beds should be equipped with ammonia monitoring devices. Only in Europe it is estimated that between 50.000 and 80.000 devices would be needed in order to equip the majority of ICU beds with AMmonia Micro SEnse Analyzers (AMMSEA). If the market is extended to USA further 60.000 AMMSE analyzers will be needed. AMMSEA will be developed in a way which enables usages for home care respectively. That means that the market can extend even more to app. up to 160.000 pieces. _x000D__x000D_TARGET INNOVATION/TECHNICAL NEED_x000D_Innovation is targeted in development of a small bed-side breath analysis system for ammonia determination in expiratory gas of critically ill. _x000D_1: The analyzing system will be non-invasive with a low detection limit of 0.1 ppm or lower. _x000D_2: The construction of the system allows connection to a mechanical ventilator which is used for respiratory support of critically ill. _x000D_3: The system will be tested in physiological and pathological conditions in different kinds of critically ill before it could be suggested to be used in every day practice. _x000D_4: Communication with the target medicine market is enhanced to enter the medicine market with the new developed and tested diagnostic system._x000D__x000D_EXPECTED IMPACT_x000D_We expect successful development and testing of sensor for on-line detection of ammonia in exhaled air of critically ill on mechanical ventilation. This allows:_x000D_1: Fast detection of changes in ammonium production in critically ill; especially in patients with acute fulminate liver failure that can develop severe brain injury._x000D_2: A close follow up of treatment efficacy in advanced liver support._x000D_3: A fast and valid detection of early liver dysfunction after liver transplantation._x000D_With continuous ammonia monitoring in expiratory gas it is expected to improve treatment of critically ill and decrease the death rate._x000D__x000D_THE CONSORTIUM_x000D_The consortium of the project consists of 2 Ps from 2 countries, all EUROSTARS members with complementary expertise and mutual business interest. They are all world market oriented and located relatively closely. The choice of the P organization was done primarily according to the criteria of complementarity. ECHO from Slovenia is a R&D performing SME that develops sensors and analyzers of various gases applicable in the fields of chemistry, medicine, biotechnology and environmental technologies. The Department of Surgery is part of one of Austria`s largest medical research institutions, the Medical University of Graz (MUG). MUG has continuously grown over the past years and has successfully attracted resources to finance its ongoing expansion. Research activities cover a broad spectrum in clinical and pre-clinical fields. The MUG has been participating in numerous EU-funded projects. It is one of the first universities in Europe which were recognized by the European Commission for “Human Resources Excellence in Research”.

Acronym AMMSE (Reference Number: 7686)
Duration 01/04/2013 - 31/03/2016
Project Topic The aim of this project is the development of a small bed-side breath analysis system for ammonia determination in expiratory gas. Having such a device in intensive care units could mean a difference between life and death for critically ill with liver and kidney disfuctions.
Network Eurostars
Call Eurostars Cut-Off 9

Project partner

Number Name Role Country
2 ECHO, razvojno tehnološki inženiring, d.o.o., (Environmental Research & Development) Coordinator Slovenia
2 Medical University of Graz Partner Austria