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临床试验/NCT03635736
NCT03635736Unknown不适用

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

University of Rostock1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年8月14日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
1
主要终点
acustocerebrography (ACG)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • suspected severe brain injury

排除标准

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

结局指标

主要结局

acustocerebrography (ACG)

时间窗: 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)

次要结局

  • 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)

研究者

发起方
University of Rostock
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Martin Sauer, MD

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

University of Rostock

研究点 (1)

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