Acustocerebrography (ACG) in Severe Brain Injury (ACG-BrainICU)

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

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.

Study Overview

• Status: Unknown
• Conditions: Brain Injuries, Acute
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Georg Richter; Phone Number: +493814946409; Email: georg.richter@med.uni-rostock.de

Study Locations

• Germany
  • Rostock, Germany, 18055
    • Recruiting
    • Intensive Care Units PIT 1+2, University hospital Rostock

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

- ICU-patients over 17 years old with suspected severe brain injury

Description

Inclusion Criteria:

• suspected severe brain injury

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
SOFA	Evaluation of the SOFA-Score	every day, at least after 28 days
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

Collaborators and Investigators

• Sponsor: University of Rostock

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 14, 2018
• Primary Completion (ANTICIPATED): August 1, 2021
• Study Completion (ANTICIPATED): October 1, 2021

Study Registration Dates

• First Submitted: July 25, 2018
• First Submitted That Met QC Criteria: August 14, 2018
• First Posted (ACTUAL): August 17, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 7, 2020
• Last Update Submitted That Met QC Criteria: April 4, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: sonography; brain damage
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries
• Other Study ID Numbers: A 2018-0062

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No