Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2010-A00890-39 | Other Identifier | ID-RCB |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 :
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| For the 97 patients | Other |
|
|
| 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 |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary outcome (1. To draw learning curves before the study begins to find out the number of ultrasound measurement needed) |
|
Not provided
Inclusion Criteria:
For the 97 patients:
Non inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Etienne JAVOUHEY, MD | HOPITAL FEMME MERE ENFANT HOSPICES CIVILS DE LYON | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pediatric Critical Care Unit, Hôpital Femme Mère Enfant ,Hospices Civils de Lyon | Bron | Auvergne-Rhône-Alpes | 69677 | France | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35733810 | Result | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| D020767 | Intracranial Thrombosis |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 1. To draw learning curves before the study begins to find out the number of ultrasound measurement needed (day 0) |
| Pediatric Critical Care Unit, CHU La Tronche |
| Grenoble |
| France |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002542 | Intracranial Embolism and Thrombosis |
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |