Intracranial Hypertension and Optic Nerve Sheath Diameter

NCT ID: NCT01796015

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 230 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2017-02-28

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

For the 97 patients

• 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

Group Type: OTHER

ONSD ultrasound

Intervention Type: 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 control group

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

Group Type: OTHER

ONSD ultrasound

Intervention Type: 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 learning curve

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.

Group Type: OTHER

ONSD ultrasound

Intervention Type: 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.

Interventions

ONSD ultrasound

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.

Intervention Type: OTHER

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

• 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

• Minimum Eligible Age: 2 Months
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Etienne JAVOUHEY, MD

Role: PRINCIPAL_INVESTIGATOR

HOPITAL FEMME MERE ENFANT HOSPICES CIVILS DE LYON

Locations

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

Bron, Auvergne-Rhône-Alpes, France

Pediatric Critical Care Unit, CHU La Tronche

Grenoble, , France

Countries

France

References

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.

Reference Type: RESULT

PMID: 35733810 (View on PubMed)

Other Identifiers

2010-A00890-39

Identifier Type: OTHER

Identifier Source: secondary_id

2010.598

Identifier Type: -

Identifier Source: org_study_id