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Intracranial Hypertension and Optic Nerve Sheath Diameter (DENO)

Primary Purpose

Cerebral Stroke, Cerebral Venous Thrombosis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ONSD ultrasound
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cerebral Stroke focused on measuring paediatrics, optic nerve sheath diameter, ultrasound

Eligibility Criteria

2 Months - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pediatric Critical Care Unit, Hôpital Femme Mère Enfant ,Hospices Civils de Lyon
  • Pediatric Critical Care Unit, CHU La Tronche

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

For the 97 patients

For the control group

For the learning curve

Arm 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

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

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Secondary outcome (1. To draw learning curves before the study begins to find out the number of ultrasound measurement needed)
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

Full Information

First Posted
October 25, 2012
Last Updated
July 25, 2018
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT01796015
Brief Title
Intracranial Hypertension and Optic Nerve Sheath Diameter
Acronym
DENO
Official Title
Intracranial Hypertension Detection Using Optic Nerve Sheath Diameter Measurement in Children
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Stroke, Cerebral Venous Thrombosis
Keywords
paediatrics, optic nerve sheath diameter, ultrasound

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
230 (Actual)

8. Arms, Groups, and Interventions

Arm Title
For the 97 patients
Arm Type
Other
Arm 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
Arm Title
For the control group
Arm Type
Other
Arm 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
Arm Title
For the learning curve
Arm Type
Other
Arm 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.
Intervention Type
Other
Intervention Name(s)
ONSD ultrasound
Intervention Description
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.
Primary Outcome Measure Information:
Title
Primary (sensitivity and specificity of echographic measurement of ONSD)
Description
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).
Time Frame
To determine diagnostic performance (sensitivity and specificity) of ICH thanks to ultrasound measurement of ONSD, (15 minutes ,before invasive ICP monitoring)
Secondary Outcome Measure Information:
Title
Secondary outcome (1. To draw learning curves before the study begins to find out the number of ultrasound measurement needed)
Description
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
Time Frame
1. To draw learning curves before the study begins to find out the number of ultrasound measurement needed (day 0)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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 history of neurological disease or learning difficulties no covered by a national health insurance
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Etienne JAVOUHEY, MD
Organizational Affiliation
HOPITAL FEMME MERE ENFANT HOSPICES CIVILS DE LYON
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pediatric Critical Care Unit, Hôpital Femme Mère Enfant ,Hospices Civils de Lyon
City
Bron
State/Province
Rhône Alpes
ZIP/Postal Code
69677
Country
France
Facility Name
Pediatric Critical Care Unit, CHU La Tronche
City
Grenoble
Country
France

12. IPD Sharing Statement

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Intracranial Hypertension and Optic Nerve Sheath Diameter

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