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Clinical Trials/NCT01796015
NCT01796015
Completed
Not Applicable

Intracranial Hypertension Detection Using Optic Nerve Sheath Diameter Measurement in Children

Hospices Civils de Lyon2 sites in 1 country230 target enrollmentApril 1, 2011

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.
Registry
clinicaltrials.gov
Start Date
April 1, 2011
End Date
February 1, 2017
Last Updated
8 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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))

Study Sites (2)

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