Brain Ultrasound in the Weaning of External Ventricular Leads
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Inter individual reproducibility of ultrasound measurement of the size of the 3rd ventricle
研究概览
简要总结
External Ventricular Deviation (EDV) is a medical device that provides transient and controlled external drainage of cerebrospinal fluid (CSF). This device can also monitor intracranial pressure (ICP). SEV is an emergency measure indicated for acute hydrocephalus and / or intracranial hypertension (HTIC). Weaning from a DVE should be considered as soon as possible from the moment the patient's clinical condition allows it. There is no consensus on how to wean SEVs.
The main objective of this study is to evaluate inter and intraobserver reproducibility of the measurement of the 3rd ventricle size by ultrasound in patients receiving a DVE withdrawal test.
详细描述
Ultrasound assessment of the ventricular system, including the size of the 3rd ventricle, can be used in severe traumatic brain injury. Ultrasound measurement of the size of the 3rd ventricle is used as a marker to monitor cerebral atrophy in neurodegenerative diseases such as multiple sclerosis (MS). There is good correlation between brain ultrasound and MRI and CT brain imaging to assess the size of the 3rd ventricle. Ultrasound measurement of the size of the 3rd ventricle has never been evaluated in weaning external ventricular leads.
Measuring the size of the 3rd ventricle by ultrasound could be an interesting monitoring technique during a SEV withdrawal trial to predict success or failure.
Weaning is usually based on a clamp test with more or less paraclinical clinical monitoring. The recurrence of hydrocephalus and / or HTIC defines a withdrawal failure of the drainage device.
The size of the 3rd ventricle evaluated by cerebral CT in a clamp test is found as a predictor of weaning failure of a DVE.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- 否
入选标准
- •Patient benefiting from a DVE, whatever the indication
- •Hospitalized in the neurosurgical resuscitation and neurosurgical intensive care units of Toulouse University Hospital
- •First DVE withdrawal test initiated by the doctor in charge of the patient
- •Major patient
- •Affiliated person or beneficiary of a social security scheme.
- •Expression of non-opposition by the participant or his / her confidant and the investigator (at the latest on the day of inclusion and before any examination required by the research).
排除标准
- •Absence of cerebral acoustic window
- •Patient with a ventriculoperitoneal (DVP) diversion before the DVE.
- •Antecedent surgery in the cerebral ventricular system.
- •Pregnant and lactating woman
- •Person under safeguard of justice
- •Nosocomial neuro-meningeal infection on untreated or treatment-emergent DVE
结局指标
主要结局
Inter individual reproducibility of ultrasound measurement of the size of the 3rd ventricle
时间窗: 3 weeks
Inter individual reproducibility of ultrasound measurement of the size of the 3rd ventricle at different study times The inter-individual reproducibility will be evaluated at each time by the analysis of a loop by 3 independent and blind operators. The analysis of all ultrasound loop recordings will be performed at the end of the participation of the last included patient. The recordings of the ultrasound loops will be coded and presented in a random and different order to each operator.
Intra individual reproducibility of ultrasound measurement of the size of the 3rd ventricle
时间窗: 3 weeks
Intra individual reproducibility of ultrasound measurement of the size of the 3rd ventricle at different study times The intra-individual reproducibility will be evaluated at each time by the acquisition of 3 ultrasound loops analyzed by the same operator. The analysis of all ultrasound loop recordings will be performed at the end of the participation of the last included patient. The recordings of the ultrasound loops will be coded and presented in a random and different order to each operator.
次要结局
- Failure of the weaning test(3 weeks)
- Measurement of the evolution of the size of the 3rd ventricle (inter individual)(3 weeks)
- Successful completion of the DVE withdrawal test(3 weeks)
- Measurement of the evolution of the size of the 3rd ventricle (intra individual)(3 weeks)