Acustocerebrography (ACG) in Severe Brain Injury

Brain Injuries, Acute Clinical Trial

— ACG-BrainICU  

Official title:

Study on Additive Use of Non-invasive Acustocerebrography in Patients Suspect to Severe Brain Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03635736
• Other study ID #: A 2018-0062
• Status: Recruiting
• Start date: August 14, 2018
• Est. completion date: October 2021

Study information

• Verified date: April 2020
• Source: University of Rostock
• Contact: Martin Sauer, MD
• Phone: +493814946409
• Email: martin.sauer[@]uni-rostock.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• suspected severe brain injury

Exclusion Criteria:

• open skull brain trauma

• skull fractures in the temporal area

• decompression-craniotomy

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Acute
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
Germany	Intensive Care Units PIT 1+2, University hospital Rostock	Rostock

Sponsors (1)

Lead Sponsor	Collaborator
University of Rostock

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	acustocerebrography (ACG)	changes in the ACG during the course of disease (especially the dimensionality of the time to flight of the ultrasound signal)	after inclusion: time-point 0 hours
Secondary	SOFA	Evaluation of the SOFA-Score	every day, at least after 28 days
Secondary	acustocerebrography (ACG)	changes in the ACG during the course of disease (especially the dimensionality of the time to flight of the ultrasound signal)	Every day to 3 time-points. The measurements will be stopped after final evaluation of the neurological status, at least after 28 days