Optic nerve ultrasound to detect brain inflammation and raised intracranial pressure
Utility of Optic Nerve Ultrasonography in Assessing Cerebral Inflammation and Intracranial Hypertension in Patients With Cerebral Impairment
This project will test whether bedside optic nerve ultrasound can quickly detect brain inflammation and high intracranial pressure in adults with suspected meningitis, encephalitis, stroke, or brain tumors.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Spitalul Clinic de Boli Infecțioase și tropicale "Dr. Victor Babeș" Academic / other |
| Locations | 2 sites (Bucharest, Bucharest and 1 other locations) |
| Trial ID | NCT07332234 on ClinicalTrials.gov |
What this trial studies
This observational study will enroll about 200 adults admitted to two Bucharest tertiary hospitals with suspected meningitis, encephalitis, stroke, or brain tumors. Trained clinicians will perform standardized optic nerve sheath diameter (ONSD) measurements using a linear probe with the patient supine at a 20–30° incline and record the mean of transverse and sagittal diameters 3 mm behind the retina. ONSD results will be compared with clinical consciousness scales, lumbar puncture findings, and available neuroimaging or intracranial pressure data to estimate sensitivity and specificity for cerebral inflammation and edema. Measurements may be repeated as clinically indicated to track changes over time.
Who should consider this trial
Good fit: Adults aged 18–60 admitted to the participating hospitals with suspected meningitis, encephalitis, stroke, or brain tumors who can undergo ocular ultrasound and relevant diagnostic tests are ideal candidates.
Not a fit: Patients younger than 18 or older than 60, those with ocular conditions that prevent eye ultrasound, or those who cannot undergo lumbar puncture or neuroimaging are unlikely to benefit from this procedure.
Why it matters
Potential benefit: If successful, this approach could provide a fast, noninvasive bedside method to identify raised intracranial pressure or persistent meningeal inflammation and speed appropriate treatment decisions.
How similar studies have performed: Previous studies have shown ONSD correlates with raised intracranial pressure in traumatic and critical care settings, but its use specifically to map meningitis-related inflammation is less established and relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients admitted into one of the specified wards of the involved hospitals * Patients aged 18-60 years * Suspected meningitis, encephalitis, stroke or cerebral tumors Exclusion Criteria: * Age under 18 years or over 60 years old * Ocular lesions preventing ocular ultrasound (palpebral infections, cornean erosions, glaucoma, trauma) * Conditions preventing lumbar puncture (coagulation disorders, epidural abscesses, local infections)
Where this trial is running
Bucharest, Bucharest and 1 other locations
- Fundeni Clinical Institute — Bucharest, Bucharest, Romania (Recruiting)
- "Dr. Victor Babeș" Clinical Hospital for Infectious and Tropical Diseases — Bucharest, Bucharest, Romania (Recruiting)
Study contacts
- Principal investigator: Bogdan Pavel, MD, PhD, DESA — "Dr. Victor Babeș" Clinical Hospital for Infectious and Tropical Diseases
- Study coordinator: Bogdan Pavel, MD, PhD, DESA
- Email: bogdan.pavel@umfcd.ro
- Phone: +40726116536
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.