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

ConditionsIntracranial Hypertension Increased Intracranial Pressure Brain Edema Traumatic Brain Injury

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorAssiut University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

85 Participants

are grouped into 1 trial group

Group A: Patients Suspected of Raised Intracranial Pressure

Trial outcomes

Primary outcomes

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).

Time frame

baseline

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: