Acustocerebrography (ACG) in Severe Brain Injury

• Conditions: Brain Injuries, Acute
• Interventions: Other: multiple-spectral-sonography as acustocerebrography (ACG)

• Registration Number: NCT03635736
• Lead Sponsor: University of Rostock

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.

Study Timeline

• Study First Submitted: 2018-07-25
• Study Start: 2018-08-14
• Study First Submitted QC: 2018-08-14
• Study First Posted: 2018-08-17
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-04
• Last Update Posted: 2020-04-07
• Primary Completion: 2021-08
• Study Completion: 2021-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• suspected severe brain injury

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Severe brain injury	multiple-spectral-sonography as acustocerebrography (ACG)	ICU-patients suspect to severe brain injury, measurement with multiple-spectral-sonography as acustocerebrography (ACG

Primary Outcome Measures

Name	Time	Method
acustocerebrography (ACG)	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

Name	Time	Method
SOFA	every day, at least after 28 days	Evaluation of the SOFA-Score
acustocerebrography (ACG)	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)

Trial Locations

Locations (1)

Intensive Care Units PIT 1+2, University hospital Rostock; 🇩🇪 Rostock, Germany