Intracranial Hypertension Detection Using Optic Nerve Sheath Diameter Measurement in Children
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cerebral Stroke
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 230
- Locations
- 2
- Primary Endpoint
- Primary (sensitivity and specificity of echographic measurement of ONSD)
- Status
- Completed
- Last Updated
- 8 months ago
Overview
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.
Investigators
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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Primary (sensitivity and specificity of echographic measurement of ONSD)
Time Frame: To determine diagnostic performance (sensitivity and specificity) of ICH thanks to ultrasound measurement of ONSD, (15 minutes ,before invasive ICP monitoring)
Sensitivity and specificity of echographic measurement of the ONSD (mean value of both eyes), taken 15 minutes ,before invasive ICP monitoring, regarding detection of ICH in children with neurological injury, as compared to reference method for ICH detection (ICP monitoring with intraventricular catheter).
Secondary Outcomes
- Secondary outcome (1. To draw learning curves before the study begins to find out the number of ultrasound measurement needed)(1. To draw learning curves before the study begins to find out the number of ultrasound measurement needed (day 0))