Acustocerebrography (ACG) in Severe Brain Injury

Study Overview
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Brief Summary
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The study will enable the clinical applicability of the multiple-spectral-sonography for detection of severe brain injury in ICU patients. For this, the ACG diagnostic system (Sonovum AG, Leipzig, Germany) should be used as additional diagnostic tool in prospective single-center study.

Detailed Description
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A multiple-step procedure, including repetition of the clinical examinations after a waiting period and use of additional technical diagnostic tools e.g. magnetic resonance tomography and Transcranial Doppler sonography (TCD) are needed for determining of severe brain injury and irreversible brain function failure. This study will enable the clinical applicability of the multiple-spectral-sonography for detection of severe brain injury in ICU patients. For this, the ACG diagnostic system (Sonovum AG, Leipzig, Germany) should be used as additional diagnostic tool in prospective single-center study. The ACG-method is a bedside non-invasive sonography that has been shown to be useful in previous studies analyzing circulatory changes in rat cerebral blood vessels, for example, to distinguish between brain-ischemia and -hemorrhage. Additionally, in the case of brain death, the spontaneous electrical activity, which can be measured by means of ACG as global elasticity, was not longer detectable. In the study should include 30 adult ICU-patients in patients suspect to severe brain injury. The inclusion of patients will be started if written informed consent was obtained from participants or their representatives. After the inclusion, the ACG is measured three times a day. In addition, the routinely practice (treatment and diagnostic) for patients with severe brain injury (neurological clinical examinations, use of additional technical diagnostic tools e.g. magnetic resonance tomography and Transcranial Doppler sonography (TCD); Standard Medical Care) should be made and documented. From all patients basic demographic data, pre-morbidity, vital parameters, blood parameters, Illness severity scores (APACHE-II, SOFA, GCS), drug levels, microbiological results and cranial MRI/CT results will be recorded.

Official Title
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Study on Additive Use of Non-invasive Acustocerebrography in Patients Suspect to Severe Brain Injury

Conditions
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Brain Injuries, Acute

Intervention / Treatment
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* Other: multiple-spectral-sonography as acustocerebrography (ACG)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: suspected severe brain injury Exclusion Criteria: open skull brain trauma skull fractures in the temporal area decompression-craniotomy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Severe brain injury<br>ICU-patients suspect to severe brain injury, measurement with multiple-spectral-sonography as acustocerebrography (ACG | Other: multiple-spectral-sonography as acustocerebrography (ACG)<br>* After inclusion three times at day measurements with ACG for each 45 minutes; a (non-invasive) sonography. The measurements will be stopped after final evaluation of the neurological status using common methods like magnetic resonance tomography, transcranial doppler sonography, electroencephalography and other methods.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acustocerebrography (ACG) | changes in the ACG during the course of disease (especially the dimensionality of the time to flight of the ultrasound signal) | after inclusion: time-point 0 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SOFA | Evaluation of the SOFA-Score | every day, at least after 28 days | 
| acustocerebrography (ACG) | changes in the ACG during the course of disease (especially the dimensionality of the time to flight of the ultrasound signal) | Every day to 3 time-points. The measurements will be stopped after final evaluation of the neurological status, at least after 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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brain damage, sonography