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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 : April 7, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Martin Sauer, MD, University of Rostock

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Brain Injuries, Acute Other: multiple-spectral-sonography as acustocerebrography (ACG)

Detailed Description:

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 Design
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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Prospective
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 2021
Estimated Study Completion Date : October 2021
Groups and Cohorts
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Group/Cohort Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. SOFA [ Time Frame: every day, at least after 28 days ]
    Evaluation of the SOFA-Score

  2. 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
- ICU-patients over 17 years old with suspected severe brain injury
Criteria

Inclusion Criteria:

  • suspected severe brain injury

Exclusion Criteria:

  • open skull brain trauma
  • skull fractures in the temporal area
  • decompression-craniotomy
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Martin Sauer, MD +493814946409 martin.sauer@uni-rostock.de
Contact: Georg Richter +493814946409 georg.richter@med.uni-rostock.de

Locations
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Germany
Intensive Care Units PIT 1+2, University hospital Rostock Recruiting
Rostock, Germany, 18055
Contact: Martin Sauer, PD Dr.    49 381 4946434      
Sponsors and Collaborators
University of Rostock
Investigators
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Principal Investigator: Martin Sauer, MD University Hospital of Rostock, Germany
More Information
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Responsible Party: Dr. Martin Sauer, MD, PD. Dr. med. habil.; Deputy on Intensive Care Medicine, University of Rostock
ClinicalTrials.gov Identifier: NCT03635736    
Other Study ID Numbers: A 2018-0062
First Posted: August 17, 2018    Key Record Dates
Last Update Posted: April 7, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Martin Sauer, MD, University of Rostock:
brain damage
sonography
Additional relevant MeSH terms:
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Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System