NCT07332234

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
17mo left

Started Dec 2025

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress27%
Dec 2025Dec 2027

Study Start

First participant enrolled

December 1, 2025

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 3, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 12, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

January 12, 2026

Status Verified

January 1, 2026

Enrollment Period

2 years

First QC Date

December 3, 2025

Last Update Submit

January 9, 2026

Conditions

MeningitisMeningitis/EncephalitisStrokeUltrasoundIntracranial HypertensionCerebral Tumors

Keywords

ONSDOptic Nerve Sheath DiameterIntracranial hypertensionMeningitisEncephalitisStrokeCerebral tumors

Outcome Measures

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

    Daily during the first week of hospitalisation

Secondary Outcomes (6)

  • C-reactive protein

    Day 1, day 3 and day 7

  • Neuron-specific Enolase

    Day 1, day 3 and day 7

  • CSF examination

    Day 1, day 3 and day 7

  • Glasgow Coma Scale

    Daily during the first week of hospitalisation

  • Richmond Agitation-Sedation Scale

    Daily during the first week of hospitalisation

  • +1 more secondary outcomes

Study Arms (2)

Infectious Pathology Group

Patients admitted into the hospital with suspected meningitis or encephalitis

Diagnostic Test: Optic Nerve Sheath Diameter

Non-Infectious Pathology Group

Patients admitted into the hospital with suspected stroke or cerebral tumors (non-infectious pathology)

Diagnostic Test: Optic Nerve Sheath Diameter

Interventions

Optic Nerve Sheath DiameterDIAGNOSTIC_TEST

Ultrasonographic measurement of the optic nerve sheath diameter

Also known as: Ocular Ultrasound, Optic Nerve Sheath Ultrasonographic Diameter
Infectious Pathology GroupNon-Infectious Pathology Group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study 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

You may qualify if:

  • Patients admitted into one of the specified wards of the involved hospitals
  • Patients aged 18-60 years
  • Suspected meningitis, encephalitis, stroke or cerebral tumors

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fundeni Clinical Institute

Bucharest, Bucharest, 022315, Romania

RECRUITING

"Dr. Victor Babeș" Clinical Hospital for Infectious and Tropical Diseases

Bucharest, Bucharest, 030303, Romania

RECRUITING

MeSH Terms

Conditions

MeningitisEncephalitisStrokeIntracranial Hypertension

Condition Hierarchy (Ancestors)

Neuroinflammatory DiseasesNervous System DiseasesBrain DiseasesCentral Nervous System DiseasesCerebrovascular DisordersVascular DiseasesCardiovascular Diseases

Study Officials

  • Bogdan Pavel, MD, PhD, DESA

    "Dr. Victor Babeș" Clinical Hospital for Infectious and Tropical Diseases

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bogdan Pavel, MD, PhD, DESA

CONTACT

+40726116536bogdan.pavel@umfcd.ro

Sebastian Isac, MD, PhD, DESA

CONTACT

+40744543736sebastian.isac@umfcd.ro

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, DESA

Study Record Dates

First Submitted

December 3, 2025

First Posted

January 12, 2026

Study Start

December 1, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

January 12, 2026

Record last verified: 2026-01

Locations

RO(2)