Intracranial Hypertension and Optic Nerve Sheath Diameter (DENO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Hospices Civils de Lyon
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01796015
First received: October 25, 2012
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

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.

Condition Intervention
Cerebral Stroke
Cerebral Venous Thrombosis
Other: ONSD ultrasound

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Intracranial Hypertension Detection Using Optic Nerve Sheath Diameter Measurement in Children

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Secondary outcome (1. To draw learning curves before the study begins to find out the number of ultrasound measurement needed) [ Time Frame: 1. To draw learning curves before the study begins to find out the number of ultrasound measurement needed (day 0) ] [ Designated as safety issue: Yes ]
    • value (mm) of the echographic ONSD measurement performed by the clinicians/interns (learning curve) compared to the value found by the trainer
    • mean value, standard deviation and quartiles of ONSD measures performed in a population of patients intubated, ventilated, sedated and without cerebral lesion (control group)
    • Correlation between echographic ONSD values (mean of the values) and invasive ICP monitoring values (taken same day)
    • Correlation between variations of ONSD measures and treatment effet on ICH
    • Comparison of diagnostic capacity of ONSD measurements depending on age, ICH etiology (bacterial meningitis, encephalitis meningitis, stroke, cerebral cerebral thrombophlebitis, TBI and patients from neurosurgery)
    • determine diagnostic capacity of the measures performed with transcranial Doppler (resistance index, pulsatility index, systolic, mean and diastolic velocities) in the different pathologies and compare them to ONSD values


Estimated Enrollment: 227
Study Start Date: April 2011
Estimated Study Completion Date: February 2015
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other: 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.

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
Other: 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.

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.
Other: 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.


  Eligibility

Ages Eligible for Study:   2 Months to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01796015

Contacts
Contact: Etienne JAVOUHEY, Professor etienne.javouhey@chu-lyon.fr
Contact: Etienne JAVOUHEY, Professor

Locations
France
Pediatric Critical Care Unit, Hôpital Femme Mère Enfant ,Hospices Civils de Lyon Recruiting
Bron, Rhône Alpes, France, 69677
Principal Investigator: Etienne JAVOUHEY, professor         
Sub-Investigator: Daniel FLORET, professor         
Sub-Investigator: Fleur ANDLAUER, MD         
Sub-Investigator: Sonio COURTIL-TEYSSEDRE, MD         
Pediatric Critical Care Unit, CHU La Tronche Recruiting
Grenoble, France
Principal Investigator: Isabelle WROBLEWSKI, MD         
Sub-Investigator: Anne MILLET, MD         
Sub-Investigator: Christophe BROUX, MD         
Département d'anesthésie réanimation, Hôpital Necker-Enfants Malades Recruiting
Paris, France
Principal Investigator: Gilles ORLIAGUET, professeur         
Sub-Investigator: Philippe MEYER, MD         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Etienne JAVOUHEY, MD HOPITAL FEMME MERE ENFANT HOSPICES CIVILS DE LYON
  More Information

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01796015     History of Changes
Other Study ID Numbers: 2010.598
Study First Received: October 25, 2012
Last Updated: May 20, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:
paediatrics
optic nerve sheath diameter
ultrasound

Additional relevant MeSH terms:
Hypertension
Stroke
Cerebral Infarction
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Intracranial Hypertension
Vascular Diseases
Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Brain Infarction
Brain Ischemia
Embolism and Thrombosis
Thromboembolism

ClinicalTrials.gov processed this record on July 23, 2014