Brain Ultrasound in the Weaning of External Ventricular Leads (ECHO-SD)

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.

Study Overview

• Status: Unknown
• Conditions: Intracranial Hypertension; Hydrocephalus
• Intervention / Treatment: Other: Measuring the size of the 3rd ventricle by ultrasound

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 Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31059
    • Recruiting
    • University Hospital Toulouse
    • Contact: Timothée ABAZIOU, MD; Phone Number: 33 05 61 32 23 84; Email: abaziou.t@chu-toulouse.fr
    • Sub-Investigator: Louis DELAMARRE, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inter individual reproducibility of ultrasound measurement of the size of the 3rd ventricle	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.	3 weeks
Intra individual reproducibility of ultrasound measurement of the size of the 3rd ventricle	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.	3 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Timothée ABAZIOU, MD, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2018
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): June 1, 2020

Study Registration Dates

• First Submitted: May 9, 2018
• First Submitted That Met QC Criteria: May 9, 2018
• First Posted (Actual): May 22, 2018

Study Record Updates

• Last Update Posted (Actual): July 23, 2018
• Last Update Submitted That Met QC Criteria: July 19, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: external ventricular derivation
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hypertension; Hydrocephalus
• Other Study ID Numbers: RC31/18/0178; 2018-A01219-46 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No