Clinical trial NCT03531723: Brain Ultrasound in the Weaning of External Ventricular Leads
Official title: Brain Ultrasound in the Weaning of External Ventricular Leads
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hydrocephalus
Intracranial Hypertension
Keywords: external ventricular derivation
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2018-05-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over 18 years-old, receiving a DVE withdrawal test and hospitalized in the neurosurgical resuscitation and neurosurgical intensive care units of Toulouse University Hospital

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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

Primary outcomes:
measure: Inter individual reproducibility of ultrasound measurement of the size of the 3rd ventricle
timeFrame: 3 weeks
measure: Intra individual reproducibility of ultrasound measurement of the size of the 3rd ventricle
timeFrame: 3 weeks
Secondary outcomes:
measure: Measurement of the evolution of the size of the 3rd ventricle (intra individual)
timeFrame: 3 weeks
measure: Measurement of the evolution of the size of the 3rd ventricle (inter individual)
timeFrame: 3 weeks
measure: Successful completion of the DVE withdrawal test
timeFrame: 3 weeks
measure: Failure of the weaning test
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Timothée ABAZIOU, MD
role: PRINCIPAL_INVESTIGATOR
References: