Traumatic Brain InjuryNCT07780279
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 of Traumatic Brain Injury, run by Assiut University.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Traumatic Brain Injury
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients with traumatic brain injury of any severity
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| study group | pediatric traumatic brain injury |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity of ONSD ultrasonography in detecting raised intracranial pressure diagnosed by brain CT findings
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdelaziz Farouk Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07780279
- Sponsor's protocol ID
- ONSD in TB
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07780279
- Acronym / sponsor ID
- ONSD in TB
- Conditions
- Traumatic Brain Injury
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 21 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | – | –pediatric traumatic brain injury |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients with traumatic brain injury of any severity
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
sensitivity of ONSD ultrasonography in detecting raised intracranial pressure diagnosed by brain CT findings
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensitivity of ONSD ultrasonography in detecting raised intracranial pressure diagnosed by brain CT findings (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.