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临床试验/NCT02408757
NCT02408757终止不适用

Multimodal Sonographic Monitoring of Cerebral Perfusion, Ventricle Seize and Optic Nerve Diameter During Weaning of Cerebrospinal Fluid Drainage Catheters: a Single Centre Observational Trial

Insel Gruppe AG, University Hospital Bern1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2015年9月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
44
试验地点
1
主要终点
binary classification of patients in terms of change of width of cerebrospinal fluid spaces by ultrasound

研究概览

简要总结

As elaborated above only one study reported ultrasonographic changes of the width of the lateral ventricle during clamping of EVD/LD and indicated that ultrasound monitoring might be suitable. No firm data exists about the change of the width of the third ventricle, the diameter of the optic nerve or brain perfusion during clamping of the EVD/LD, although the width of these structures has been shown to depend on intracranial pressure. Ultrasonographic measurements of changes of the width of the third ventricle or the diameter of the optic nerve would have some advantages compared to the ultrasonographic assessments of the lateral ventricles. First, the width of the third ventricle can be measured easier and more reliable than the width of the lateral ventricles (better defined insonation plane and therefore higher repeatability of measurements) 3. Second, whereas assessments of the width of the side and third ventricles with ultrasound depend on the temporal bone windows (10 to 15% of patients have insufficient temporal bone windows), the measurement of the diameter of the optic nerve does not have this limitation and can therefore be performed in almost all patients. Hence, measurement of the diameter of the optic nerve would allow to overcome one major limitation of transcranial ultrasound. The latter limitation for transcranial ultrasound could also be minimized by the use of an ultrasound contrast agent (SonoVue®), but this was also not yet studied. The use of an ultrasound contrast agent would in addition allow to study changes of brain perfusion during clamping of EVD/LD.

详细描述

Background

Placement of a CSF drainage catheter (external ventricular drainage (EVD) or lumbar drainage (LD)) is a frequent neurosurgical emergency intervention. It is used in case of obstructive hydrocephalus as it can occur after e.g. intracerebral hemorrhage with intraventricular involvement, subarachnoid hemorrhage or traumatic brain injury but also in situations with reduced CSF resorption or increased CSF production (e.g. meningitis, ventriculitis). Furthermore, this technique can be used to monitor intracranial pressure. In all these situations, the EVD/LD can be used to reduce the elevated intracranial pressure during the acute phase. However, because of impairment of the Paccioni granulations by blood and its breakdown products, a continuing hydrocephalus may develop, leading to permanent necessity of CSF drainage. To evaluate the need for a permanent (implanted) drainage system (e.g. ventriculoperitoneal or ventriculoatrial shunt) attempts to clamp the EVD/LD are carried out during the subacute phase. Successful clamping is verified by absent increase of intracranial pressure, absent clinical deterioration and lack of ventricular enlargement on serial CT scans. The latter means that a first CT scan has to be performed before clamping of the drainage catheter (baseline examination) and again 24 hours after clamping of the drainage catheter. This leads to the need for repeated transportations of critically ill patients with possible harm of the patient, high costs, need for more staff and repeated exposure of the patient to radiation. Hence, a simple, repeatable, non-invasive, bedside tool for diagnosis of ventricular enlargement due to clamping of EVD/LD is strongly needed.

Transcranial ultrasound has become a widely used technique mainly for measuring arterial blood flow velocities. More recently, transcranial ultrasound has been also used to assess brain tissue, brain perfusion and ventricular size. The major advantages of ultrasound are its non-invasive character, the possibility for bedside application, low costs and safety (no X-ray exposure). Some studies have tried to use transcranial ultrasound for indirect assessment of intracranial pressure. As target structures for transcranial ultrasound either the lateral ventricles, the third ventricle or the diameter of the optic nerve were used. All studies could demonstrate a correlation between the width of the lateral or third ventricle or the diameter of the optic nerve with intracranial pressure. To the investigators' knowledge, only one study assessed the change of the width of the lateral ventricles during clamping of EVD/LD.

To summarize, a bedside method for assessment of changes of ventricle width/diameter of the optic nerve during clamping of EVD/LD is urgently needed and would facilitate the procedure, higher patient safety and lower costs. By now, there are some promising ultrasound methods (transcranial ultrasound with or without contrast enhancing agent to determine the width of the side and third ventricle, diameter of the optic nerve), which might substitute repeated CT scans but have not been evaluated for monitoring clamping of EVD/LD.

Objective

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Informed consent of patient or relative and statement of independent physician
  • Patient treated with EVD or LD undergoing clamping of EVD/LD
  • Age ≥18 ≤ 80 years
  • Exclusion Criteria
  • Pregnancy and breastfeeding
  • Acute coronary syndromes, severe ischemic heart disease (requiring revascularisation), severe aortic and mitral valve disease, severe congestive heart failure (NYHA >III/IV)
  • Severe pulmonary or renal dysfunction
  • Known allergy or adverse reaction to contrast material

排除标准

  • 未提供

结局指标

主要结局

binary classification of patients in terms of change of width of cerebrospinal fluid spaces by ultrasound

时间窗: 24 hours after clamping of EVD/LD

次要结局

  • change of width of the third ventricle measured with transcranial ultrasound without ultrasound contrast agent(24 hours after clamping of EVD/LD)
  • change of width of the third ventricle measured with transcranial ultrasound with ultrasound contrast agent(24 hours after clamping of EVD/LD)
  • change of width of the lateral ventricles measured with transcranial ultrasound without ultrasound contrast agent(24 hours after clamping of EVD/LD)
  • change of diameter of the optic nerve(24 hours after clamping of EVD/LD)
  • change of width of the third ventricle in the CT scan(24 hours after clamping of EVD/LD)
  • change of width of the lateral ventricles in the CT scan(24 hours after clamping of EVD/LD)
  • change of brain perfusion in the brain regions adjacent to the third ventricle(24 hours after clamping of EVD/LD)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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