Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07799714

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

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.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Intracranial Hypertension Brain Diseases Brain Edema Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Increased Intracranial Pressure Nervous System Diseases Trauma, Nervous System Traumatic Brain Injury Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: baseline

    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).

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 2, 2026
Registry last updated
Sep 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.