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Not yet recruitingNCT07780279Updated Aug 21, 2026

Diagnostic Accuracy of Bedside Optic Nerve Sheath Diameter Ultrasonography for Detecting Raised Intracranial Pressure Compared With Brain CT Findings in Children With Traumatic Brain Injury

An observational study in Traumatic Brain Injury, sponsored by Assiut University. Not yet recruiting. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-08-21.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
6 Years to 12 Years
Sex
All
01

Study summary

Traumatic brain injury (TBI) is a major cause of morbidity and mortality among children globally, with an estimated incidence ranging from 47 to 280 cases per 100,000 children (1). The burden of pediatric traumatic brain injury (pTBI) in low- and middle-income countries (LMICs) is characterized, because most pTBI occurs in LMICs (2). TBIs can have both short- and long-term effects including impairment of physical, cognitive, or emotional functions (3). Advances in acute trauma care have decreased mortality rates (4). Elevated intracranial pressure (ICP) following TBI or stroke has been recognized as an important second insult that is strongly correlated with increased mortality. Therefore, an increase in ICP can cause a decrease in brain perfusion and may result in brain ischemia (5). Early detection of raised intracranial pressure (RICP) is considered a better strategy to prevent secondary brain insult (6). The gold standard for ICP measurement is invasive techniques (i.e., ventriculostomy and intraparenchymal microtransducers), associated with risks, such as infection and haemorrhage (7). Several methods for noninvasive measuring of elevated ICP have been proposed: radiologic methods including computed tomography and ophthalmological techniques (8). Some brain computed tomography (CT) findings, such as brain parenchymal swelling, midline shifting, and compressed basal cisterns, are traditionally used for the indirect measurement of raised ICP (9). Among non-invasive methods, the measurement of optic nerve sheath diameter (ONSD) has gained particular interest (7). The optic nerve sheath is continuous with the meninges of the central nervous system and is encased with the subarachnoid membrane. Cerebrospinal fluid (CSF), located in the subarachnoid space, accumulates in the optic nerve sheath, thereby widening its diameter in the setting of increased ICP and limited intracranial compliance (10). Ultrasound assessments of ONSD could be a better option because of the low cost and rapid bedside operation without the need for radiation exposure, especially for cases that are unstable and require real-time monitoring of ICP in an intensive care unit (11). Despite existing research, there remains a gap in evaluating the diagnostic accuracy of the ONSD measured via ultrasound for the prediction of increased ICP in pediatric patients (12). This study aims to assess the diagnostic accuracy of bedside optic nerve sheath diameter ultrasonography for detecting raised intracranial pressure in pediatric traumatic brain injury using brain CT findings as the reference standard.

02

Conditions studied

  • Traumatic Brain Injury
03

Who can participate

Ages eligible
6 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with traumatic brain injury of any severity

Inclusion criteria

  • 1. Children aged 6-12 years. 2. Patients presenting within 24 hours of traumatic brain injury. 3. Patients undergoing brain CT based on emergency department and neurosurgical assessment.

    4. Patients with traumatic brain injury of any severity, as assessed by the Paediatric Glasgow Coma Scale (PGCS).

    5. Haemodynamically stable patients who can undergo ocular ultrasonography.

Exclusion criteria

Exclusion Criteria:

  • 1. Orbital fractures, globe rupture, extensive periorbital oedema preventing right ONSD measurement.

    2. Earlier intracranial surgery or ventriculoperitoneal shunt. 3. Known congenital or got neurological disorders associated with altered intracranial pressure (e.g., hydrocephalus or intracranial tumours).

    4. Patients transferred after receiving osmotherapy before the initial ONSD measurement.

04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • study group

    pediatric traumatic brain injury

05

What researchers measure

Primary outcomes

  1. sensitivity of ONSD ultrasonography in detecting raised intracranial pressure diagnosed by brain CT findings

    Time frame: baseline

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT07780279
Lead sponsor
Assiut University
Responsible party
Ahmed Abdelaziz Farouk Ahmed (residant doctor at Assiut university hospital, Assiut University) — Principal investigator
First posted
Aug 21, 2026
Start date
Oct 2026 (estimated)
Primary completion
Oct 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Aug 21, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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