Brain Ultrasound in the Weaning of External Ventricular Leads

NCT ID: NCT03531723

Last Updated: 2018-07-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-07-12
• Study Completion Date: 2020-06-30

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.

Conditions

Hydrocephalus; Intracranial Hypertension

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

Measuring the size of the 3rd ventricle by ultrasound

The surveillance of the clamping test is essentially clinical. No cerebral imaging is performed systematically in our service protocol.The study consisted of including ultrasound measurements during the usual weaning protocol of the service.All patients receiving a SEV withdrawal test will be included. Inclusion begins when the clinician in charge of the patient initiates the withdrawal test. The measurements will be performed blindly by a trained physician who does not participate in the patient's care. Four measurements will be made, with recording of ultrasound loops

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Timothée ABAZIOU, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

University Hospital Toulouse

Toulouse, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Timothée ABAZIOU, MD

Role: CONTACT

abaziou.t@chu-toulouse.fr

05 61 32 23 84 ext. 33

Isabelle Olivier, PhD

Role: CONTACT

olivier.i@chu-toulouse.fr

05 61 77 70 51 ext. 33

Facility Contacts

Timothée ABAZIOU, MD

Role: primary

abaziou.t@chu-toulouse.fr

05 61 32 23 84 ext. 33

Isabelle Olivier, PhD

Role: backup

olivier.i@chu-toulouse.fr

05 61 77 70 51 ext. 33

Other Identifiers

2018-A01219-46

Identifier Type: OTHER

Identifier Source: secondary_id

RC31/18/0178

Identifier Type: -

Identifier Source: org_study_id