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Operational decision not to proceed at this stage.
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Intracranial pressure (ICP) monitoring is indicated in a wide range of neurological diseases. The combination of a linear ultrasound array with an integrated pressure sensor into a single handheld probe (ICP Probe) enables the user to precisely and non-invasively estimate blood pressure in a superficial vein overlying a hard structure. The periorbital vein located on the forehead above the eye is an interesting target since it is an emissary vein, directly connected through valveless vessels to the intracranial venous system. Its pressure might thus reflect intracranial pressure if it can be measured before being equalized by redistribution across the whole facial venous network. The usage of a pneumatic mask able to transiently occlude the site of measurement from the superficial venous network might therefore enable to correlate the venous occlusion pressure (VOP) of the periorbital vein to ICP. To confirm the hypothesis, the current clinical trial will compare measurements made with the CPMX3 system with invasively obtained ICP measures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPMX3 measurement | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPMX3 measurement | Device | CPMX3 ICP measurement |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety of venous occlusion pressure of the isolated periorbital vein measured with the CPMX3 System to estimate ICP in pediatric patients. | - Safety of the device shall be evaluated by systematically reporting Device Deficiencies (DDs), Adverse Device Effects (ADEs) and Serious Adverse Device Effects (SADEs) and by monitoring the frequency and incidence of these events. The practitioner will be asked to identify any new risks arising during the measurements using the investigational device. | Up to 7 days |
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| Measure | Description | Time Frame |
|---|---|---|
| Preliminary accuracy of CPMX3 measurement of ICP via the occlusive pressure measuremnet of the supraorbital vein | Preliminary accuracy will be assessed by recording paired measurements of venous occlusion pressure of the periorbital vein when isolated from its surrounding network and invasive ICP measurements from the standard of care intraventricular monitor to compute: | Up to 7 days |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's National Hospital | Washington D.C. | District of Columbia | 20010 | United States |
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Investigator performing the pressure measurement with CPMX3 will be blinded from the invasive intracranial pressure value for the duration of measurement with CPMX3
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