Cerebral StrokeDENONCT01796015
Intracranial Hypertension and Optic Nerve Sheath Diameter
A study testing ONSD ultrasound in people with Cerebral Stroke and Cerebral Venous Thrombosis, run by Hospices Civils de Lyon at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 months to 16 years
- Conditions the study is for
- Cerebral Stroke, Cerebral Venous Thrombosis
- What is being tested?
- ONSD ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 2 sitesFrance
- Study dates
- Apr 2011to Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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:
Show all 12Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Pediatric Critical Care Unit, Hôpital Femme Mère Enfant ,Hospices Civils de Lyon
Bron, Auvergne-Rhône-Alpes, 69677
Pediatric Critical Care Unit, CHU La Tronche
Grenoble
About this study
Official title: Intracranial Hypertension Detection Using Optic Nerve Sheath Diameter Measurement in Children
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
- Being tested
- ONSD ultrasound
- Keywords
- paediatrics, optic nerve sheath diameter, ultrasound
- Medical subject headings
- Stroke, Intracranial Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONSD ultrasoundOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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. Receives: Other: ONSD ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
- 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
Measured: 1. To draw learning curves before the study begins to find out the number of ultrasound measurement needed (day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2013 (estimated)
- Study startApr 2011
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral StrokeStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Etienne JAVOUHEY, MD, Principal investigator, HOPITAL FEMME MERE ENFANT HOSPICES CIVILS DE LYON
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01796015
- Sponsor's protocol ID
- 2010.598
- Other IDs
- 2010-A00890-39
- Acronym
- DENO
- Status last verified
- Aug 2025
- First submitted
- 25 Oct 2012
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 35733810
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracranial Hypertension Detection Using Optic Nerve Sheath Diameter Measurement in Children
- ClinicalTrials.gov ID
- NCT01796015
- Acronym / sponsor ID
- DENO / 2010.598
- Conditions
- Cerebral Stroke, Cerebral Venous Thrombosis
- Keywords
- paediatrics, optic nerve sheath diameter, ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 21 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| For the 97 patients | Other | Other: ONSD ultrasound* 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 |
| For the control group | Other | Other: ONSD ultrasoundone 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 |
| For the learning curve | Other | Other: ONSD ultrasoundminimum 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. |
Who may qualify
- Ages
- 2 months to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ONSD ultrasoundDescription 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. | Other | For the 97 patients, For the control group, For the learning curve |
Primary outcome
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)
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).
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Results publication: PubMed 35733810Cour-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Etienne JAVOUHEY, MD principal investigator
HOPITAL FEMME MERE ENFANT HOSPICES CIVILS DE LYON
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ONSD ultrasound in people with Cerebral Stroke and Cerebral Venous Thrombosis, run by Hospices Civils de Lyon at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01796015, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.