About this trial
Timely detection of signs of raised intracranial pressure or persistent inflammation within the meninges can expedite therapeutic decisions improving the prognosis of patients with brain damage. Optic nerve ultrasonography provides a user-friendly, safe, low-cost, and non-invasive imaging method that can be easily deployed for ICU patient assessment. This study aims to evaluate the sensitivity and specificity of optic nerve ultrasound in estimating cerebral inflammation extension and cerebral edema in patients in the ICU. The working hypothesis is that optic nerve ultrasound is a useful tool in the rapid diagnosis of cerebral edema and the presence or persistence of cerebral inflammation, which can enable adapted and rapid therapeutic interventions.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients admitted into one of the specified wards of the involved hospitals
Patients aged 18-60 years
Suspected meningitis, encephalitis, stroke or cerebral tumors
Disqualifiers
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)
Trial population
Patients admitted into the Anesthesia and Intensive Care Department of the Fundeni Clinical Institute in Bucharest, and the Anesthesia and Intensive Care Department and Infectious Diseases departments of the "Dr. Victor Babes" Hospital of Infectious Diseases in Bucharest
Trial design
Cohort
Prospective
Treatments tested in this trial
Optic Nerve Sheath Diameter
Diagnostic testUltrasonographic measurement of the optic nerve sheath diameter
Treatment groups
Trial outcomes
Primary outcomes
Optic Nerve Sheath Diameter
The diameter of the optic nerve sheath measured ultrasonographically using a standardised method, 6mm from the surface of the retina
Secondary outcomes
C-reactive protein
Measurement of systemic C-reactive protein (CRP) levels, as marker of systemic inflammation
Neuron-specific Enolase
Measurement of neuron-specific enolase as a marker for brain cell death caused by CNS inflammation.
CSF examination
Determining CSF immune cell count, CSF proteins, albumin, glucose, chloride and sodium, as well as bacterial or fungal cultures (where applicable).
Glasgow Coma Scale
Evaluation tool used to assess a person's level of consciousness after brain injury or illness, rating their eye, verbal, and motor responses for a total score ranging from 3 (deep unconsciousness) to 15 (fully alert).
Sponsors and contacts
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Spitalul Clinic de Boli Infecțioase și tropicale "Dr. Victor Babeș"
Lead sponsor
Institutul Clinic Fundeni
Collaborator