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Clinical Trials/NCT03635736
NCT03635736
Unknown
Not Applicable

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

University of Rostock1 site in 1 country30 target enrollmentAugust 14, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Brain Injuries, Acute
Sponsor
University of Rostock
Enrollment
30
Locations
1
Primary Endpoint
acustocerebrography (ACG)
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 14, 2018
End Date
October 2021
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University of Rostock
Responsible Party
Principal Investigator
Principal Investigator

Dr. Martin Sauer, MD

PD. Dr. med. habil.; Deputy on Intensive Care Medicine

University of Rostock

Eligibility Criteria

Inclusion Criteria

  • suspected severe brain injury

Exclusion Criteria

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

Outcomes

Primary Outcomes

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 Outcomes

  • SOFA(every day, at least after 28 days)
  • 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)

Study Sites (1)

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