Non-invasive intracranial pressure estimation using periorbital vein occlusion pressure
Non-invasive Intracranial Pressure Estimation by Measurement of the Occlusion Pressure of the Isolated Periorbital Vein (NICE-ICP)
This test tries to estimate intracranial pressure without surgery by measuring occlusion pressure in the vein around the eye in adults who already have an invasive ICP monitor.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Compremium AG Industry-sponsored |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT07222826 on ClinicalTrials.gov |
What this trial studies
The procedure uses a pneumatic mask and ultrasound to isolate and measure the occlusion pressure of the periorbital vein, aiming to derive a non-invasive estimate of intracranial pressure. Measurements are performed in hospitalized adults who already have an invasive ICP monitor so the new method can be directly compared to gold-standard readings. Patients with facial or skull trauma, recent cranial surgery, orbital venous disease, or active bleeding are excluded to avoid interference with measurements. The trial is conducted at Baylor College of Medicine and uses concurrent invasive ICP readings as the reference standard.
Who should consider this trial
Good fit: Ideal participants are adults (over 18) hospitalized with a clinically placed invasive ICP monitor and without facial/skull trauma, recent cranial surgery, orbital venous disease, or active bleeding.
Not a fit: Patients with facial or skull trauma, recent cranial surgery or hemicraniectomy, orbital pathology or known ophthalmic vein stenosis, active bleeding, or those not already fitted with an invasive ICP monitor will likely not benefit or be eligible.
Why it matters
Potential benefit: If successful, this method could allow reliable, non-surgical ICP monitoring and reduce the need for invasive catheters and their associated risks such as infection and bleeding.
How similar studies have performed: Other non-invasive ICP techniques (for example optic nerve sheath diameter or transcranial Doppler) have shown mixed results, and periorbital vein occlusion pressure is a relatively novel approach with limited prior clinical validation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female * Age \> 18 * Equipped with an invasive ICP monitor as part of standard of care Exclusion Criteria: * Presence of facial and/or skull trauma that could hinder placement of the pneumatic mask or contraindicate ultrasound on the forehead * History of recent cranial surgery or hemicraniectomy * Active bleeding (proven or suspected) * History or known pathological condition or injury linked to the orbital socket influencingvenous outflow (e.g. Grave disease, tumor, inflammation, trauma, glaucoma, etc.) * History, or known vein stenosis in ophthalmic veins/cavernous sinus * Any other condition that would interfere with measurement technique and routine clinical care according to the judgment of the investigator.
Where this trial is running
Houston, Texas
- Baylor College of Medicine — Houston, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Damon Judges
- Email: d.judges@compremium.ch
- Phone: +41775071995
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.