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Brain Ultrasound in the Weaning of External Ventricular Leads

Brain Ultrasound in the Weaning of External Ventricular Leads

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03531723
Acronym
ECHO-SD
Enrollment
30
Registered
2018-05-22
Start date
2018-07-12
Completion date
2020-06-30
Last updated
2018-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hydrocephalus, Intracranial Hypertension

Keywords

external ventricular derivation

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.

Interventions

OTHERMeasuring 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

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Inter individual reproducibility of ultrasound measurement of the size of the 3rd ventricle3 weeksInter 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.
Intra individual reproducibility of ultrasound measurement of the size of the 3rd ventricle3 weeksIntra 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.

Secondary

MeasureTime frameDescription
Measurement of the evolution of the size of the 3rd ventricle (intra individual)3 weeksIntra individual reproducibility of the ultrasound measurement of the evolution of the size of the 3rd ventricle
Measurement of the evolution of the size of the 3rd ventricle (inter individual)3 weeksInter individual reproducibility of the ultrasound measurement of the evolution of the size of the 3rd ventricle
Successful completion of the DVE withdrawal test3 weeksSuccessful completion of the DVE withdrawal test, defined by the absence of the need to decline or rest a DVE at 3 weeks.
Failure of the weaning test3 weeksFailure of the weaning test defined by the need to decline or rest a DVE at 3 weeks.

Countries

France

Contacts

Primary ContactTimothée ABAZIOU, MD
abaziou.t@chu-toulouse.fr05 61 32 23 84
Backup ContactIsabelle Olivier, PhD
olivier.i@chu-toulouse.fr05 61 77 70 51

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026