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

NCT07799714 | Not Yet Recruiting

• 1 other identifier: ONSD Ultrasound in Raised ICP
• Study Type: observational
• Target: 85
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Area Under the Receiver Operating Characteristic Curve (AUC-ROC) for Detecting Raised Intracranial Pressure

  The 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).

  baseline

Study Arms (1)

Patients Suspected of Raised Intracranial Pressure

Adult patients aged 18 years or older with clinical suspicion of acutely raised intracranial pressure (e.g., altered consciousness, progressive headache, vomiting, papilledema, or focal neurological deficits) who are referred to undergo a non-contrast brain CT scan. ll enrolled participants undergo bedside transorbital high-resolution ultrasonography using a 7.5-15 MHz linear-array transducer to measure the optic nerve sheath diameter (ONSD) at 3 mm posterior to the globe in both eyes. Ultrasonographic findings are compared with non-contrast brain CT findings (the reference standard), which are independently evaluated by blinded neuroradiologists for signs of elevated intracranial pressure.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients aged 18 years or older admitted to the emergency department or intensive care units at Assiut University Hospital with clinical suspicion of acutely raised intracranial pressure (such as altered level of consciousness, progressive headache, vomiting, papilledema, or focal neurological deficits) who are referred to the Diagnostic Radiology Department for a non-contrast brain CT scan.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Intracranial Hypertension; Brain Edema; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Radiology

Study Record Dates

• First Submitted: August 30, 2026
• First Posted: September 2, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: September 2, 2026

Record last verified: 2026-08