Acustocerebrography (ACG) in Severe Brain Injury (ACG-BrainICU)
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|ClinicalTrials.gov Identifier: NCT03635736|
Recruitment Status : Recruiting
First Posted : August 17, 2018
Last Update Posted : August 22, 2018
|Condition or disease||Intervention/treatment|
|Brain Injuries, Acute||Other: multiple-spectral-sonography as acustocerebrography (ACG)|
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.
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||Study on Additive Use of Non-invasive Acustocerebrography in Patients Suspect to Severe Brain Injury|
|Actual Study Start Date :||August 14, 2018|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||October 2020|
Severe brain injury
ICU-patients suspect to severe brain injury, measurement with multiple-spectral-sonography as acustocerebrography (ACG
Other: 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.
- acustocerebrography (ACG) [ Time Frame: after inclusion: time-point 0 hours ]changes in the ACG during the course of disease (especially the dimensionality of the time to flight of the ultrasound signal)
- SOFA [ Time Frame: every day, at least after 28 days ]Evaluation of the SOFA-Score
- acustocerebrography (ACG) [ Time Frame: Every day to 3 time-points. The measurements will be stopped after final evaluation of the neurological status, at least after 28 days ]changes in the ACG during the course of disease (especially the dimensionality of the time to flight of the ultrasound signal)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03635736
|Contact: Martin Sauer, MDfirstname.lastname@example.org|
|Contact: Georg Richteremail@example.com|
|Intensive Care Units PIT 1+2, University hospital Rostock||Recruiting|
|Rostock, Germany, 18055|
|Contact: Martin Sauer, PD Dr. 49 381 4946434|
|Principal Investigator:||Martin Sauer, MD||University Hospital of Rostock, Germany|