Intracranial Hypertension and Optic Nerve Sheath Diameter (DENO)

Civil Hospices of Lyon

Status: Completed

Conditions: Cerebral Venous Thrombosis; Cerebral Stroke

Treatments: Other: ONSD ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT01796015

2010-A00890-39 (Other Identifier)

2010.598

Details and patient eligibility

About

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.

Enrollment: 230 patients

Sex: All

Ages: 2 months to 16 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

230 participants in 3 patient groups

For the 97 patients

Other group

Description:

* day 0: ultrasound of ONSD (= 4 measurements: 1 transverse and 1 sagittal for each eye) + transcranial Doppler at T-15 (15 minutes before ICP measurement), within 1h following ICP measurement, and one more measurement is to be done if significant ICP variations are noticed (variation over 15 mmHg during at least 5 minutes) * day 1: ONSD ultrasound + transcranial Doppler in the morning and one more measurement is to be done if significant ICP variations are noticed (variation over 15 mmHg during at least 5 minutes) * days 2 and 3 : same as day 1 * when leaving the intensive care unit: Pediatric Overall Performance Category (POPC) scale

Treatment:

Other: ONSD ultrasound

For the control group

Other group

Description:

one single ONSD in addition to their usual care (4 measurements: 1 transverse and 1 sagittal for each eye) in the morning in absence of painful sensation

Treatment:

Other: ONSD ultrasound

For the learning curve

Other group

Description:

minimum 15 ONSD ultrasounds will be performed by each of the 15 intensive care doctor or interns expected. One ONSD ultrasound corresponds to 2 measurements: 1 transverse and 1 sagittal. Each volunteer will have maximum 30 ONSD ultrasound measures over a 1 month period.

Treatment:

Other: ONSD ultrasound