Brain Ultrasound in the Weaning of External Ventricular Leads

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Brief Title

Brain Ultrasound in the Weaning of External Ventricular Leads

Official Title

Brain Ultrasound in the Weaning of External Ventricular Leads

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 Type

Observational


Primary Outcome

Inter individual reproducibility of ultrasound measurement of the size of the 3rd ventricle

Secondary Outcome

 Measurement of the evolution of the size of the 3rd ventricle (intra individual)

Condition

Hydrocephalus

Intervention

Measuring the size of the 3rd ventricle by ultrasound


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

30

Start Date

July 12, 2018

Completion Date

June 2020

Primary Completion Date

June 2020

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Timothée ABAZIOU, MD, 05 61 32 23 84, [email protected]

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT03531723

Organization ID

RC31/18/0178

Secondary IDs

2018-A01219-46

Responsible Party

Sponsor

Study Sponsor

University Hospital, Toulouse


Study Sponsor

Timothée ABAZIOU, MD, Principal Investigator, University Hospital, Toulouse


Verification Date

July 2018