Acustocerebrography (ACG) in Severe Brain Injury
ACG-BrainICU
Study on Additive Use of Non-invasive Acustocerebrography in Patients Suspect to Severe Brain Injury
1 other identifier
observational
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2018
CompletedStudy Start
First participant enrolled
August 14, 2018
CompletedFirst Posted
Study publicly available on registry
August 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2021
CompletedApril 7, 2020
April 1, 2020
3 years
July 25, 2018
April 4, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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 Arms (1)
Severe brain injury
ICU-patients suspect to severe brain injury, measurement with multiple-spectral-sonography as acustocerebrography (ACG
Interventions
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.
Eligibility Criteria
\- ICU-patients over 17 years old with suspected severe brain injury
You may qualify if:
- suspected severe brain injury
You may not qualify if:
- open skull brain trauma
- skull fractures in the temporal area
- decompression-craniotomy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Intensive Care Units PIT 1+2, University hospital Rostock
Rostock, 18055, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martin Sauer, MD
University Hospital of Rostock, Germany
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PD. Dr. med. habil.; Deputy on Intensive Care Medicine
Study Record Dates
First Submitted
July 25, 2018
First Posted
August 17, 2018
Study Start
August 14, 2018
Primary Completion
August 1, 2021
Study Completion
October 1, 2021
Last Updated
April 7, 2020
Record last verified: 2020-04