Optic Nerve Ultrasound for Assessing Cerebral Inflammation and Intracranial Hypertension in Cerebral Pathologies

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorSpitalul Clinic de Boli Infecțioase și tropicale "Dr. Victor Babeș"

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Optic Nerve Sheath Diameter

    Diagnostic test

    Ultrasonographic measurement of the optic nerve sheath diameter

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Infectious Pathology Group1 intervention
Group B: Non-Infectious Pathology Group1 intervention

Trial outcomes

Primary outcomes

1

Optic Nerve Sheath Diameter

The diameter of the optic nerve sheath measured ultrasonographically using a standardised method, 6mm from the surface of the retina

Time frame
Daily during the first week of hospitalisation

Secondary outcomes

1

C-reactive protein

Measurement of systemic C-reactive protein (CRP) levels, as marker of systemic inflammation

Time frame
Day 1, day 3 and day 7
2

Neuron-specific Enolase

Measurement of neuron-specific enolase as a marker for brain cell death caused by CNS inflammation.

Time frame
Day 1, day 3 and day 7
3

CSF examination

Determining CSF immune cell count, CSF proteins, albumin, glucose, chloride and sodium, as well as bacterial or fungal cultures (where applicable).

Time frame
Day 1, day 3 and day 7
4

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).

Time frame
Daily during the first week of hospitalisation

Other outcomes

Sponsors and contacts

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