An observational study in Hydrocephalus and Intracranial Hypertension, sponsored by University Hospital, Toulouse. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-23.
Sponsored by University Hospital, Toulouse · Observational
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.
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.
210 studies on the registry are indexed under Hydrocephalus; 51 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 98 observational studies indexed under Hydrocephalus.
Browse Hydrocephalus studies →University Hospital, Toulouse is the lead sponsor of 794 studies on the registry; 214 are open to participants now.
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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
Exclusion Criteria:
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
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.
Time frame: 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.
Time frame: 3 weeks
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
Time frame: 3 weeks
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
Time frame: 3 weeks
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.
Time frame: 3 weeks
Failure of the weaning test
Failure of the weaning test defined by the need to decline or rest a DVE at 3 weeks.
Time frame: 3 weeks
Plan to share: No
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This study is status unknown, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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University Hospital, Toulouse