Intracranial Hypertension and Optic Nerve Sheath Diameter

NCT01796015 | Completed DMC

• 2 other identifiers: 2010.5982010-A00890-39
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 2

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.

Conditions

Cerebral Stroke; Cerebral Venous Thrombosis

Keywords

paediatrics; optic nerve sheath diameter; ultrasound

Outcome Measures

Primary Outcomes (1)

• Primary (sensitivity and specificity of echographic measurement of ONSD)

  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).

  To determine diagnostic performance (sensitivity and specificity) of ICH thanks to ultrasound measurement of ONSD, (15 minutes ,before invasive ICP monitoring)

Secondary Outcomes (1)

• 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 Arms (3)

For the 97 patients

OTHER

* 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

Other: ONSD ultrasound

For the control group

OTHER

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

Other: ONSD ultrasound

For the learning curve

OTHER

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.

Other: ONSD ultrasound

Interventions

ONSD ultrasound OTHER

Description of the ONSD ultrasound: ONSD is measured 3 mm behind the globe and perpendicularly to the optic nerve axis (2 dimensions mode). For each optic nerve, 2 measures are performed: 1 sagittal and 1 transverse. The patient is positioned in 30° dorsal elevation. Gel is applied on the eyelid and a 7,5 MHz probe is used. At the same time and on the same side, a transcranial Doppler is performed using a 2 MHz probe placed on the temple. Are measured: systolic velocity, mean velocity, diastolic velocity, resistance index and pulsatility index. As ONSD measures cannot be done blinded (regarding ICP monitoring), a centralised evaluation (by 2 experts) of the recorded sonograms is planned.

For the 97 patients; For the control group; For the learning curve

Eligibility Criteria

• Age: 2 Months - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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
• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (2)

Pediatric Critical Care Unit, Hôpital Femme Mère Enfant ,Hospices Civils de Lyon

Bron, Auvergne-Rhône-Alpes, 69677, France

Location

Pediatric Critical Care Unit, CHU La Tronche

Grenoble, France

Location

Related Publications (1)

• Cour-Andlauer F, Portefaix A, Wroblewski I, Rabilloud M, Bordet F, Cogniat B, Didier C, Pouyau R, Valla FV, Kassai-Koupai B, Simeon G, Ginhoux T, Courtil-Teyssedre S, Javouhey E. Predictive Value of Optic Nerve Sheath Diameter for Diagnosis of Intracranial Hypertension in Children With Severe Brain Injury. Front Pediatr. 2022 Jun 6;10:894449. doi: 10.3389/fped.2022.894449. eCollection 2022.

  PMID: 35733810 RESULT

MeSH Terms

Conditions

Stroke; Intracranial Thrombosis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Embolism and Thrombosis; Thromboembolism; Embolism and Thrombosis

Study Officials

• Etienne JAVOUHEY, MD

  HOPITAL FEMME MERE ENFANT HOSPICES CIVILS DE LYON

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2012
• First Posted: February 21, 2013
• Study Start: April 1, 2011
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: September 4, 2025

Record last verified: 2025-08

Locations

FR (2)