Brain Ultrasound in the Weaning of External Ventricular Leads

• Conditions: Hydrocephalus; Intracranial Hypertension

• Registration Number: NCT03531723
• Lead Sponsor: University Hospital, Toulouse

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.

Study Timeline

• Study First Submitted: 2018-05-09
• Study First Submitted QC: 2018-05-09
• Study First Posted: 2018-05-22
• Status Verified: 2018-07
• Study Start: 2018-07-12
• Last Update Submitted: 2018-07-19
• Last Update Posted: 2018-07-23
• Primary Completion: 2020-06
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Inter individual reproducibility of ultrasound measurement of the size of the 3rd ventricle	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	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.

Secondary Outcome Measures

Name	Time	Method
Failure of the weaning test	3 weeks	Failure of the weaning test defined by the need to decline or rest a DVE at 3 weeks.
Measurement of the evolution of the size of the 3rd ventricle (inter individual)	3 weeks	Inter individual reproducibility of the ultrasound measurement of the evolution of the size of the 3rd ventricle
Successful completion of the DVE withdrawal test	3 weeks	Successful completion of the DVE withdrawal test, defined by the absence of the need to decline or rest a DVE at 3 weeks.
Measurement of the evolution of the size of the 3rd ventricle (intra individual)	3 weeks	Intra individual reproducibility of the ultrasound measurement of the evolution of the size of the 3rd ventricle

Trial Locations

Locations (1)

University Hospital Toulouse; 🇫🇷 Toulouse, France