Brain Ultrasound in the Weaning of External Ventricular Leads

Hydrocephalus Clinical Trial

— ECHO-SD  

Official title:

Brain Ultrasound in the Weaning of External Ventricular Leads

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03531723
• Other study ID #: RC31/18/0178
• Secondary ID: 2018-A01219-46
• Status: Recruiting
• Start date: July 12, 2018
• Est. completion date: June 2020

Study information

• Verified date: July 2018
• Source: University Hospital, Toulouse
• Contact: Timothée ABAZIOU, MD
• Phone: 05 61 32 23 84
• Email: abaziou.t[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hydrocephalus
• Intracranial Hypertension

Intervention

Other:
• 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

Locations

Country	Name	City	State
France	University Hospital Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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