Brain Ultrasound in the Weaning of External Ventricular Leads

NCT03531723 | Unknown

• 2 other identifiers: RC31/18/01782018-A01219-46
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Hydrocephalus; Intracranial Hypertension

Keywords

external ventricular derivation

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

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

  3 weeks

• Measurement of the evolution of the size of the 3rd ventricle (inter individual)

  3 weeks

• Successful completion of the DVE withdrawal test

  3 weeks

• Failure of the weaning test

  3 weeks

Interventions

Measuring the size of the 3rd ventricle by ultrasound OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients over 18 years-old, receiving a DVE withdrawal test and hospitalized in the neurosurgical resuscitation and neurosurgical intensive care units of Toulouse University Hospital

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital Toulouse

Toulouse, 31059, France

RECRUITING

MeSH Terms

Conditions

Hydrocephalus; Intracranial Hypertension

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Timothée ABAZIOU, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Timothée ABAZIOU, MD

CONTACT

05 61 32 23 84; abaziou.t@chu-toulouse.fr

Isabelle Olivier, PhD

CONTACT

05 61 77 70 51; olivier.i@chu-toulouse.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2018
• First Posted: May 22, 2018
• Study Start: July 12, 2018
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: July 23, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)