Clinical trial NCT03635736: Acustocerebrography (ACG) in Severe Brain Injury
Official title: Study on Additive Use of Non-invasive Acustocerebrography in Patients Suspect to Severe Brain Injury
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Brain Injuries, Acute
Keywords: brain damage
sonography
Lead sponsor: University of Rostock
Sponsor class: OTHER
First posted: 2018-08-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: - ICU-patients over 17 years old with suspected severe brain injury

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.

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.

Eligibility criteria: Inclusion Criteria:

* suspected severe brain injury

Exclusion Criteria:

* open skull brain trauma
* skull fractures in the temporal area
* decompression-craniotomy

Primary outcomes:
measure: acustocerebrography (ACG)
timeFrame: after inclusion: time-point 0 hours
Secondary outcomes:
measure: SOFA
timeFrame: every day, at least after 28 days
measure: acustocerebrography (ACG)
timeFrame: Every day to 3 time-points. The measurements will be stopped after final evaluation of the neurological status, at least after 28 days
Other outcomes:
Locations:
city: Rostock
country: Germany
facility: Intensive Care Units PIT 1+2, University hospital Rostock
Study officials:
affiliation: University Hospital of Rostock, Germany
name: Martin Sauer, MD
role: PRINCIPAL_INVESTIGATOR
References: