Clinical trial NCT01796015: Intracranial Hypertension and Optic Nerve Sheath Diameter
Official title: Intracranial Hypertension Detection Using Optic Nerve Sheath Diameter Measurement in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Stroke
Cerebral Venous Thrombosis
Keywords: paediatrics
optic nerve sheath diameter
ultrasound
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2013-02-21
Enrollment: 230
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Intracranial hypertension (ICH) is a mortality risk factor in severe traumatic brain injury (TBI), in purulent meningitis, in hepatic encephalopathy and in Reye's syndrome. It is also a risk factor for severe neurologic sequelae in survivors. Intracranial pressure (ICP) monitoring is likely to guide therapeutics, and certain research on adults or on children, suggest that IH therapeutic approach, for instance for bacterial meningitis, would improve the prognosis. Two monitoring techniques are currently recommended. They are reference methods for ICP measure :

* monitoring with intraventricular catheter,
* intra-parenchymal monitoring using optical fiber catheter. Non invasive methods have been suggested, including ultrasound measurement of optic nerve sheath diameter (ONSD) which is the most interesting one. The ONSD measured ultrasonically is correlated with ICP level in adults with severe TBI. A diameter over 5,9 mm predicts ICH within the first 24 hours. In children, ONSD average values have been worked out, and an ONSD increase is found in children suffering from hydrocephalus with IH and in children with TBI. ICH precocious detection is fundamental in children sensitive to ICH because their cerebral development is not finished yet. Difficulties met for ICP monitoring implementation in infants and its invasive nature are often disliked by clinicians. A non-invasive exam is then essential to allow a better care of children with ICH in intensive care unit.


Eligibility criteria: Inclusion Criteria:

For the 97 patients:

* children from 2 months to 16 years
* in the intensive care unit
* TBI : moderate (GCS between 9 and 12) to severe (GCS \<9), whatever the mechanism involved
* informed consent form signed by parents

Non inclusion Criteria:

* obesity (BMI \> 97th percentile for the age)
* patient already under replacement therapy.
* patient taking AEDs
* patient with long-term systemic corticosteroid therapy
* history of neurological disease or learning difficulties
* no covered by a national health insurance

Primary outcomes:
measure: Primary (sensitivity and specificity of echographic measurement of ONSD)
timeFrame: To determine diagnostic performance (sensitivity and specificity) of ICH thanks to ultrasound measurement of ONSD, (15 minutes ,before invasive ICP monitoring)
Secondary outcomes:
measure: Secondary outcome (1. To draw learning curves before the study begins to find out the number of ultrasound measurement needed)
timeFrame: 1. To draw learning curves before the study begins to find out the number of ultrasound measurement needed (day 0)
Other outcomes:
Locations:
city: Bron
country: France
facility: Pediatric Critical Care Unit, Hôpital Femme Mère Enfant ,Hospices Civils de Lyon
state: Rhône Alpes
city: Grenoble
country: France
facility: Pediatric Critical Care Unit, CHU La Tronche
Study officials:
affiliation: HOPITAL FEMME MERE ENFANT HOSPICES CIVILS DE LYON
name: Etienne JAVOUHEY, MD
role: PRINCIPAL_INVESTIGATOR
References: