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Not yet recruitingNCT06726681Updated Dec 10, 2024

Assessment of Intracranial Pressure Using Optic Nerve Sheath Diameter in Head Trauma in Assiut University

An observational study in Head Trauma Injury, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-12-10.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Primary completion was expected by Apr 2026, 6 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
143
Ages
18 Years to 80 Years
Sex
All
01

Study summary

Clinical performance of optic nerve sheath diameter measurement using ultrasound in comparison of CT brain to measure the intra cranial pressure in head trauma

Read the detailed description

Traumatic head injuries (THI) are one of the major causes of mortality and morbidity world wild. Head injuries contribute to almost 50% of all injuries. Nowadays, head injury has become one of the biggest issues of almost more than 57 million people in the whole world living with the neurological problem raised by TBI, in which 10 million people require hospital base care[1].

in many developing countries, head injury is one of the commonest life-threatening injuries among trauma victims[2]. In Egypt, injuries are many times larger than documented as a result of underreporting and misdiagnosis[3].

Elevated intracranial pressure (ICP) is a challenging and potentially fatal complication of acute head trauma. The elevation in intracranial pressure might lead to life-threatening conditions such as brainstem herniation and compromises cerebral perfusion. Early detection of raised intracranial pressure (RICP) is considered a better strategy to prevent secondary brain insults[2]. Early intervention in the form of either surgical evacuation of the space-occupying haematoma or medical management of the raised ICP is required, and cranial CT is necessary in deciding whether or not to operate. However, direct measurement of raised ICP requires an invasive procedure: the insertion of an ICP monitoring catheter. 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[4]. Although the invasive methods such as intraparenchymal and intra-ventricular devices are the reference standard for ICP monitoring but they not always used due to many causes such as unavailability of the technique expert in many hospitals, presence of contraindications (coagulopathy) and cost. In addition, they have serious complications such as intra-cranial hemorrhage, seizure and infection[5].

Some non-invasive methods for measuring ICP can be used as alternatives to invasive techniques, including transcranial Doppler, tympanic membrane displacement, optic nerve sheath diameter (ONSD), computed tomography (CT), magnetic resonance imaging (MRI), and fundoscopy [6]. These non-invasive techniques do not carry the risk of complications as with invasive methods. Recently, adult studies have reported that measuring ONSD with non-invasive imaging technologies such as CT, MRI and ultrasound can be used as an alternative method to evaluate increased ICP[7]. However, CT and MRI for ONSD measurements are time-consuming, costly and usually require patient transportation. Thus, 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 [8].

Several neuroimaging efforts have targeted novel methods for triaging head injury and early prognostication. The most popular, which is the ONSD measurement, has become a valuable adjunct to other clinical and laboratory prognostic indices, such as the Glasgow Coma Score (GCS)[9]. The measurement of ONSD can be performed as an alternative to invasive methods, because it can be performed bedside, with comparable results to invasive methods as well as a sensitivity and specificity of more than 90% [10].

The optic nerve sheath enclosing the optic nerve surrounds the optic subarachnoid space and is directly linked to the intracranial subarachnoid space. A rise in ICP pushes cerebrospinal fluid (CSF) from the intracranial cavity into the optic subarachnoid space with a resultant distension of the optic nerve sheath and its diameter. This uninterrupted connection provides easy access to measure ICP transmitted through the optic nerve sheath. ONSD assessment via ultrasonography is reflective of the variation in intracranial tension. The ONSD is known to increase within seconds of raised ICP, and this rise in ONSD is followed by a concurrent optic disk edema [11].

ONSD measurement can be performed using three methods: ultrasonography (USG), computed tomography (CT), and magnetic resonance imaging (MRI). In a meta-analysis that compared the usefulness of these three methods for ONSD measurement in cases of increased intracranial pressure, USG showed higher diagnostic accuracy than the other two methods [12]. In addition, because USG does not cause ionizing radiation exposure and can be easily performed at bedside in a short time and can be repeated, it is considered more advantageous than the other methods and is preferred more often in diagnostic studies[13].

This study is to determine the accuracy of optic nerve sheath dilatation, as measured by bedside ultrasonography, in predicting elevated ICP and the need for surgical intervention among people with head injury.

02

Conditions studied

  • Head Trauma Injury

Keywords

  • optic nerve sheath diameter
03

In context

Craniocerebral Trauma

253 studies on the registry are indexed under Craniocerebral Trauma; 45 are open to participants now.

This study's planned enrollment of 143 is below the median of 180 across 108 observational studies indexed under Craniocerebral Trauma.

Browse Craniocerebral Trauma studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

head trauma patient

Inclusion criteria

  • Patients aged from > 18 years old. Both male and female patients. GCS\<15 post injury or pt sent to CT scan by neurosurgery for Intracranial injury's Patients with no past or current neurological or neuro-ophthalmological diseases and normal neurological exams .

Exclusion criteria

Exclusion Criteria:

  • Pregnant women. Patients with severe orbital trauma. penetrating eye injury, or other ocular pathologies such as glaucoma, optic neuritis, central retinal vein/artery occlusion, retrobulbar hematoma or orbital cellulitis.

Patient with preexisting neurological diseases. Blind patients. Patients with cardiac arrest . Patients who refused participation in the study.

05

Study design

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

Groups and cohorts

  • head trauma

    Trauma patients admitted to Emergency department with a history of acute head injury and loss of consciousness

06

What researchers measure

Primary outcomes

  1. Optic nerve sheath diameter

    Optic nerve sheath diameter measurement inmm using ultrasound immediately before CT

    Time frame: baseline

Secondary outcomes

  1. Trauma severity score 2-GCS 3_outcome of patient

    Time frame: baseline

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06726681
Lead sponsor
Assiut University
Responsible party
Fatma Abdelhameed sedeek khalid (Assessment of intracranial pressure using optic nerve sheath diameter in head trauma in Assiut University Emergency department, Assiut University) — Principal investigator
First posted
Dec 10, 2024
Start date
Apr 2025 (estimated)
Primary completion
Apr 2026 (estimated)
Completion
Sep 2026 (estimated)
Last update
Dec 10, 2024

Study contacts

Fatma Abdelhameed sedeek Khalid
Contact
fatmasedeek232@gmail.com
+201125052165

Oversight

Data monitoring committee
No
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 Dec 2024. You cannot join it, but the record below documents what was studied.

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