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