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Bedside Ultrasound Measurement of Optic Nerve Sheath Diameter for Detecting Raised Intracranial Pressure

Role of Bedside Ultrasound Measurement of Optic Nerve Sheath Diameter in the Early Detection of Raised Intracranial Pressure: A Comparative Study With CT Brain Findings

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07799714
Enrollment
85
Registered
2026-09-02
Start date
2026-10-01
Completion date
2027-11-01
Last updated
2026-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Edema, Increased Intracranial Pressure, Intracranial Hypertension, Traumatic Brain Injury

Keywords

Optic Nerve Sheath Diameter, ONSD, Point-of-Care Ultrasound, Bedside Ultrasonography, CT Brain, Diagnostic Accuracy

Brief summary

Raised intracranial pressure (ICP) is a serious medical emergency that requires prompt recognition to prevent brain damage. While invasive pressure monitoring and brain CT scans are commonly used, bedside transorbital ultrasonography to measure optic nerve sheath diameter (ONSD) offers a rapid, non-invasive alternative. The purpose of this study is to evaluate the diagnostic accuracy of bedside ultrasound measurement of ONSD in detecting raised ICP in adult patients, using brain CT scan findings as the reference standard. Adult patients clinically suspected of having elevated intracranial pressure and referred for a brain CT scan will undergo a non-invasive bedside ocular ultrasound examination. The optic nerve sheath diameter will be measured in both eyes and compared with independent CT brain interpretations to assess sensitivity, specificity, and the optimal diagnostic cut-off value.

Interventions

None listed

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* Adults aged ≥ 18 years * Clinical suspicion of acutely raised intracranial pressure (e.g., altered level of consciousness, papilledema, progressive headache, vomiting, or focal neurological deficits) * Referred to undergo a brain CT scan * Hemodynamically stable at the time of ultrasound examination

Exclusion criteria

* Pre-existing orbital or ocular trauma * Known history of optic nerve disease (e.g., optic neuritis or glaucoma) * Previous ocular or intraorbital surgery * Severe ocular pathology preventing safe transorbital ultrasonographic assessment * Refusal to participate or lack of informed consent from the patient or legal guardian

Design outcomes

Primary

MeasureTime frameDescription
Area Under the Receiver Operating Characteristic Curve (AUC-ROC) for Detecting Raised Intracranial PressurebaselineThe diagnostic performance of bedside transorbital optic nerve sheath diameter (ONSD) measurement in differentiating between patients with and without raised intracranial pressure will be evaluated using Receiver Operating Characteristic (ROC) curve analysis against the non-contrast brain CT reference standard. The Area Under the Curve (AUC) ranges from 0.5 (no discrimination) to 1.0 (perfect discrimination).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 3, 2026