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Trial record 16 of 29 for:    Recruiting, Not yet recruiting, Available Studies | "Hydrocephalus"

Brain Ultrasound in the Weaning of External Ventricular Leads (ECHO-SD)

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ClinicalTrials.gov Identifier: NCT03531723
Recruitment Status : Recruiting
First Posted : May 22, 2018
Last Update Posted : July 23, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

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.


Condition or disease Intervention/treatment
Hydrocephalus Intracranial Hypertension Other: Measuring the size of the 3rd ventricle by ultrasound

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
Estimated Enrollment : 30 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Brain Ultrasound in the Weaning of External Ventricular Leads
Actual Study Start Date : July 12, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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


Primary Outcome Measures :
  1. Inter individual reproducibility of ultrasound measurement of the size of the 3rd ventricle [ Time Frame: 3 weeks ]

    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.


  2. Intra individual reproducibility of ultrasound measurement of the size of the 3rd ventricle [ Time Frame: 3 weeks ]

    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.



Secondary Outcome Measures :
  1. Measurement of the evolution of the size of the 3rd ventricle (intra individual) [ Time Frame: 3 weeks ]
    Intra individual reproducibility of the ultrasound measurement of the evolution of the size of the 3rd ventricle

  2. Measurement of the evolution of the size of the 3rd ventricle (inter individual) [ Time Frame: 3 weeks ]
    Inter individual reproducibility of the ultrasound measurement of the evolution of the size of the 3rd ventricle

  3. Successful completion of the DVE withdrawal test [ Time Frame: 3 weeks ]
    Successful completion of the DVE withdrawal test, defined by the absence of the need to decline or rest a DVE at 3 weeks.

  4. Failure of the weaning test [ Time Frame: 3 weeks ]
    Failure of the weaning test defined by the need to decline or rest a DVE at 3 weeks.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03531723


Contacts
Contact: Timothée ABAZIOU, MD 05 61 32 23 84 ext 33 abaziou.t@chu-toulouse.fr
Contact: Isabelle Olivier, PhD 05 61 77 70 51 ext 33 olivier.i@chu-toulouse.fr

Locations
France
University Hospital Toulouse Recruiting
Toulouse, France, 31059
Contact: Timothée ABAZIOU, MD    05 61 32 23 84 ext 33    abaziou.t@chu-toulouse.fr   
Contact: Isabelle Olivier, PhD    05 61 77 70 51 ext 33    olivier.i@chu-toulouse.fr   
Sub-Investigator: Thomas GEERAERTS, MD         
Sub-Investigator: Louis DELAMARRE, MD         
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Timothée ABAZIOU, MD University Hospital, Toulouse

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03531723     History of Changes
Other Study ID Numbers: RC31/18/0178
2018-A01219-46 ( Other Identifier: ID-RCB )
First Posted: May 22, 2018    Key Record Dates
Last Update Posted: July 23, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Toulouse:
external ventricular derivation

Additional relevant MeSH terms:
Hydrocephalus
Intracranial Hypertension
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases