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

NCT07780279 | Not Yet Recruiting

• 1 other identifier: ONSD in TB
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

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

  baseline

Study Arms (1)

study group

pediatric traumatic brain injury

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Patients with traumatic brain injury of any severity

You may qualify if:

• \. 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.
• \. Patients with traumatic brain injury of any severity, as assessed by the Paediatric Glasgow Coma Scale (PGCS).
• \. Haemodynamically stable patients who can undergo ocular ultrasonography.

You may not qualify if:

• \. Orbital fractures, globe rupture, extensive periorbital oedema preventing right ONSD measurement.
• \. Earlier intracranial surgery or ventriculoperitoneal shunt. 3. Known congenital or got neurological disorders associated with altered intracranial pressure (e.g., hydrocephalus or intracranial tumours).
• \. Patients transferred after receiving osmotherapy before the initial ONSD measurement.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: residant doctor at Assiut university hospital

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: August 21, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 21, 2026

Record last verified: 2026-08