Validation of Non-Invasive Intracranial Pressure Estimation Using CPMX3 in the Periorbital Vein: A Feasibility Study in Pediatric Patients

Withdrawn before enrolling · Not applicable

Conditions studied: Intracranial Pressure

In brief

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.

Key facts

Study ID: NCT07550361
Run by: Compremium AG
People needed: 0
Starts: 2025-04-22
Expected to finish: 2026-04-30
Last updated by the study team: 2026-04-24

Who can join

Age: 8 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Parent/guardian or alert subject (age 18 or over) capable of giving consent; subject less than 18 and of assent age must give assent to participate if appropriate and required by the institution. If the subjects are incapable of giving assent, then only parent/guardian consent is required
Male or female
Age: 8 to 21 years of age
Equipped with an ICP monitor (intraparenchymal probe or EVD) as part of standard of care

You may not qualify if…

Presence of facial trauma that could hinder placement of the pneumatic mask or contraindicate ultrasound on the forehead
Presence of fractures of the skull
Any other condition that would interfere with measurement technique and routine clinical care according to the judgment of the investigator.

Where it is running

Children's National Hospital — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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