The ACG Procedure, which has been developed by Sonovum AG and is based on proprietary patents, is a supplement and alternative method for high-radiation and cost-intensive procedures like MRI or CT.
In Permanent Monitoring on the ICU as well as before, during and after surgery settings, ACG can be used for monitoring brain tissue in real time. In a number of research cooperations, we are aiming at the CE sign for a IIb Medical Device (MDR).
"In a pilot trial about the diagnosis of septic encephalopathies (early septicemia syndrom), we researched how ACG can be used fot its identification. The preliminary results have been very promising which is why we are going ahead and planning the next step of this study setting. It will be multicentric and comprise more patients, more diagnosis methods as well as more elaborate testing methodolgy. For us, this area of pre-diagnosis and Permanent Monitoring shows a lot of further potential: with ACG, we want to be able to diagnose the septic encephalopathy while it evolves. During that period, we want to study its process in order to help patients earlier and more effectively than we traditionally can.“
PD Dr. Martin Sauer, University Medicine Rostock
Clinic for Anaesthesiology and Intensive Care
After his studies in medicine at the University of Rostock, PD Dr. Martin Sauer worked at their research laboratories "Detoxification". Later, he became an assistant dcotor for Internal Medicine, Anaesthesiology and Intensive Care. He is a specialist for Anaesthesiology, as well as Energency Care and Intensive Medicine. Since 2013, he has been chief resident in his field. Additionally, he has been deputy chief of Peri-Operative Intensive Therapy (PIT) since 2016.
In 2013, he habilitated about "Extracorporal Septicemia Therapy/Cell Based Therapy of Sepsis and Diagnosis of Hepatotoxicity". He focuses on extracorporal methods of sepsis and liver therapy, as well as novel methods for early diagnosis of organ failure. Furthermore, he researches cell based sensors and toxicity of medicinal products as well as neurological complications of septicemia in general.
Dr. Sauer has been chief coordinator for clinical studies at University Medicine Rostock since 2015. He is also doing research in his fields with the Fraunhofer Institute IZI for Cell Therapy and Immunology Leipzig, at its Rostock branch EXIM which he co-founded. He is a member of the German Society for Anaesthesiology and Intensive Care (DGAI) and its Scientific Study Group "Intensive Care", as well as of SepNet and Competence Cluster Septicemia.
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Sonovum Acoustocerebrographs provide continuous observation of processes in the brain tissue, especially before, during and after surgery. Thus, they enable physicians to coem up with a more precise diagnosis, thus facilitating better treatment results.
When a mobile intensive care unit is called in after a severe accident or because a condition has worsened spontaneously, its main task is to monitor and stabilize the patient. To ensure this, vital parameters are monitored continuously and reported to hospital staff when the patient is admitted. Transferring patients to the ICU subsequently means raised levels of monitoring and care.
These units are therefore equipped with more staff and more equipment. Both allow for monitoring the patient’s vital signs in shorter intervals or continuously. In particular, early detection of significant changes can make a crucial difference in patients with traumatic brain injury (TBI) or subarachnoid hemorrhage (SAH).
The underlying physical considerations lead to the assumption that, for example, a significant increase in intracranial pressure will be reflected in RTI and ATN change (density and elasticity of the brain tissue). Thus, the multispectral diagnostic ultrasound could be regarded as an alternative, non-invasive method to intracranial pressure probes and might be used as an early warning system in Intensive Care Units, both mobile and stationary.
This research area addresses questions of how to technologically and physically implement the ACG device into mobile and stationary ICUs with regard to tube placement, recording frequency and data synchronization. Additionally, research might provide an answer to the question of how CT and MRI utilization can benefit from initial diagnosis at the site of an accident.
Today, patients with subarachnoid hemorrhage and traumatic brain injury are being multimodal monitored, i.e. blood pressure, pulse, temperature, oxygen saturation and intracranial pressure are continuously measured, in order to adequately respond if they move into the critical range. These parameters are measured by different devices and need to be time-synchronized in order to obtain a meaningful comprehensive picture. Sonovum Acoustocerebrographs allow continuous non-invasive monitoring of these patients.
Neurosurgical procedures normally require sedation (anesthesia) of the patient. However, each time patients are anesthetized, assessment of their neurological state becomes more difficult, because the central nervous system is not in a "normal state." At the same time, the state of the brain tissue continuously changes during surgery. Especially in severe cases, such as a subarachnoid hemorrhage (SAH, a special type of brain hemorrhage) and traumatic brain injury (TBI), these changes can be serious and have an accordingly decisive influence on the state of the brain and thus the course of the operation. More than 1.3 million incidents of TBI are recorded in the US alone.1 Therefore, it is of paramount importance to the operating neurosurgeon that these changes are constantly being monitored. In order to do this, a number of vital signs such as blood pressure, temperature and pulse are continuously monitored. However, these only allow an assessment of the general condition of the patient. Monitoring of the brain itself is critically important in cases like this.
This is done mainly by means of two parameters: intracranial pressure of the cerebrospinal fluid (or ICP), and intracranial oxygen saturation. The intracranial pressure is usually measured invasively, i.e. with a probe, which is introduced through a hole in the skull. This means an increased risk of infection.
There are indicators that Acoustocerebrography may be able to non-invasively measure intracranial pressure. This would make it possible, for the first time, to ensure comprehensive monitoring of the brain. Since the headset is easy to use, it can be used over extended periods, before, during and after surgery. Thus, Acoustocerebrography could close both the existing gap in preventative diagnosis and in the early and acute phases of central nervous system diseases.
Both urbanization and an aging population are prevalent trends of our time. Particularly, older people as well as people living in rural areas are faced with major implications that these trends impose on our health care system. The Sonovum ACG device could contribute significantly in providing preventive care as well as acute diagnostics by ensuring safe brain monitoring everywhere, by anyone.
Worldwide, the population is becoming increasingly urban. While in 1950, 30% of the global population was urban, today this share is at 54%. By 2050, it will have grown to 66%. Furthermore, almost one billion of these urban dwellers live in slums or non-durable housing, i.e. in regions with inferior infrastructure.1
This has significant implications on global health care. In general, people living in rural areas seem to show different health-related behavior than those living in cities,2 which means that the health needs of both groups have to be addressed individually.
Specifically, the rural population often lacks access to health care.3 Worldwide, rural areas are underserviced by approximately 7 million health care professionals. This means that only 23% of the global health workforce is deployed in these areas, although almost half of the world’s population is living there. Prevalent mostly in Asia and Africa, this lack of coverage is often the result of weak legal requirements. But even in countries where health care is guaranteed by law, enforcement in these areas often fails to live up to the standards of Europe or North America.4
At the same time, societies all over the world have to organize health care for an increasingly older population: The global share of people aged 60 years and over increased from 9.2% in 1990 to 11.7% in 2013 and will continue to grow as a proportion of the world population, reaching 21.1% by 2050.5
Health care concepts need to factor in these developments if they are to cope with these major shifts. For both rural populations as well as older people (and, of course, especially for older people in rural or urban areas) preventive medical diagnosis and treatment would increase significantly if brain monitoring could be administered at home and by medical laypersons like family and friends. Sonovum ACG devices can address this challenge: Their ease-of-use, portable size and, in future, wireless data transfer capability enable any physician to conduct a remote diagnosis. Sonovum also plans to equip ACG devices with an alarm feature which will make them ideal devices for home care and nursing home facilities.
Whenever your head is involved in an accident scenario, monitoring of neurological functions is a top priority. After all, chances for recovery are significantly higher if edema and internal bleeding are identified immediately after the incident. Sonovum Acoustocerebrographs can help close the gap between isolated monitoring points provided by MRI and CT by offering a real time view of changes in cerebral tissue and fluids.
When a patient is admitted with (suspected) traumatic brain injury or a stroke, the first thing that has to be established is whether an operation is necessary. To assess this, typically speech, coordination, eye sight and other reflexes are checked. Further measures like CT and MRI will be considered as the circumstances require, on a regular basis if necessary,1 thereby providing the physician over the next hours and days with recurring, but isolated measurements of the brain tissue’s condition. The challenging part of interpreting these results comes with their distribution over time. They merely offer singular glimpses of the patient’s status at a given point in time; however, the majority of time during the patient’s supervision remains unmonitored.
Chances are that bleedings and edema may not occur during these short points of supervised time, but within the longer, unmonitored intervals in between. With imaging technology, this means that they will be detected long after they occurred, which is precisely what reduces a patient’s recovery prospects.2
A continuous real-time brain monitoring solution that can be applied when the first symptoms occur, like a simple headache, would provide a remedy. Offering portable mobility, Sonovum Acoustocerebrographs could serve as that remedy – at home as well as in settings with medical professionals. Furthermore, these devices could be applied directly after any incident involving head trauma, providing uninterrupted monitoring starting from the moment of an accident, fall or any other relevant incident.
This area of research focuses on the questions, how accurately will Sonovum Acoustocerebrographs be able to identify hidden strokes, how do changes in brain tissue manifest themselves in coma patients, and whether indicators for Alzheimer’s disease and Parkinson’s can be identified in patients at an early stage.
In every individual, the blood-brain barrier regulates the uptake of substances to the brain. With ACG, we want to research the efficacy of medication reaching the brain and answer the question whether that medication fulfills the task it is designed for. In essence, we want to establish an individual Brain Uptake Index (BUI).
The brain is protected by the blood-brain barrier (BBB), a specialized system of capillary endothelial cells that strictly limits transport into the brain through both physical (tight junctions) and metabolic (enzymes) barriers.1 It serves thus as an access control and crucially influences neural brain activity. Its task is twofold: to keep out harmful substances that either are on their way too often, too fast or in concentrations too high to handle; and to let in those substances that are intended to heal and therefore are required to pass the barrier without restriction.
The former are more often found in elderly patients, where more time may have passed allowing a higher concentration of toxins to collect in the body and the brain. Additionally, recent evidence suggests that the BBB’s breakdown is an early event in the aging human brain, which would amplify the effect.2 Independent of age, it can be said that not everyone reacts to the same medication in the same way, which makes it considerably more difficult to determine a dosage individually engineered to match the organism’s needs.
This challenge can be observed when the latter is on the agenda, for example with antidepressants. Their effectiveness is occasionally delayed by days, sometimes even weeks. Moreover, it has been argued that, in a large number of cases, their effect fails to materialize altogether.3 Overall, substances with larger molecules as well as hydrophilic substances show a weaker permeability.
Up until now, efforts to measure this have yielded unsatisfying results: Pharmacokinetics, concerned with uptake, transport, distribution and dissipation of substances in the human body, can indeed discern certain levels of accumulation by means of blood sampling; also, various tests exist that, at the BBB itself, establish which conditions are either ideal or adverse for permeability by means of genetic markers. But, as of today, a non-invasive technology resulting in precisely measured information about accumulation levels of medication does not exist.
This research area aims at answering the question, whether patients show individual patterns of how medication accumulates in the brain tissue.
What potential do you see for our Acoustocerebrography in your environment? Contact us and let's talk about your specific application.
Sauer et al: "Diagnose einer septischen Enzephalopathie durch Akustocerebrografie - Ergebnisse einer Pilotstudie"; Poster presented at DIVI Leipzig, Dec 8, 2017; E-Poster Ref. No. EP/11/01
Sievert et al: "Pilotstudie zur Diagnose einer septischen Enzephalopathie durch Akustocerebrografie - Zwischenauswertung"; Poster presented at DAC Nuremberg, May 4, 2017; E-Poster Ref. No. 2.2.12
Olszewski et al: "The novel non-invasive ultrasound device for detecting early changes of the brain in patients with heart failure", European Journal of Heart Failure 2016, Volume 18, Issue Supplement S1
Bogdan et al: Computer Aided Multispectral Ultrasound Diagnostics Brain Health Monitoring System based on Acoustocerebrography, Conference Paper submitted for MEDICO 2016, Cyprus
The procedure and range of options offered by this device are to a certain extent, unlimited. We have already explored some applications; many others have also been hypothesized.
The interpretation of the measurement results and its correlation with clinical data is an ongoing process. Cooperation with a variety of specialized doctors using the ACG device suggests that new medical findings can be discovered and explored.
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Detection of Septicemia, Multicentric Study following successful Pilot Trial
Prospective ACG Monitoring for correlation of established monitoring procedures: Intracranial Pressure, Bleedings and Edema
Head of research: Dino Podlesek
Die Klinik für Neurochirurgie am Universitätsklinikum der TU Dresden kooperiert mit der Sonovum AG, um bei Patienten in stationärer und/oder intensivmedizinischer Behandlung das ACG-Monitoring zu untersuchen. Prospektive Studien sollten das diagnostische ACG-Monitoring in Korrelation zu bereits etablierten klinischen Messverfahren (transkranielle Doppler-Sonographie, intrakranielle invasive Hirndruckmessung, externe Ventrikeldrainage, bildgebende Verfahren) untersuchen. Dazu werden ACG-Messungen bei Patienten mit erweiterten Liquorräumen (z.B. Normaldruckhydrocephalus), Hirnblutungen und anderen intrakraniellen Raumforderungen vorgenommen.
Brain Monitoring in Intensive Care
Head of Research: Dr. Dirk Lindner
In cooperation with the Clinic of Neurosurgery, the research project will assess how ACG can contribute to the multimodal monitoring conducted with patients in Intensive Care Units.
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