Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
30 participants
OBSERVATIONAL
2018-08-14
2021-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Severe brain injury
ICU-patients suspect to severe brain injury, measurement with multiple-spectral-sonography as acustocerebrography (ACG
multiple-spectral-sonography as acustocerebrography (ACG)
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.
Interventions
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multiple-spectral-sonography as acustocerebrography (ACG)
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* skull fractures in the temporal area
* decompression-craniotomy
18 Years
ALL
No
Sponsors
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University of Rostock
OTHER
Responsible Party
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Dr. Martin Sauer, MD
PD. Dr. med. habil.; Deputy on Intensive Care Medicine
Principal Investigators
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Martin Sauer, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Rostock, Germany
Locations
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Intensive Care Units PIT 1+2, University hospital Rostock
Rostock, , Germany
Countries
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Central Contacts
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Facility Contacts
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Martin Sauer, PD Dr.
Role: primary
Other Identifiers
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A 2018-0062
Identifier Type: -
Identifier Source: org_study_id
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