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Head Trauma InjuryNCT06726681

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

An observational study of Head Trauma Injury, run by Assiut University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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 more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Head Trauma Injury
How many people
143 participants
Where
No sites listed yet
Study dates
Apr 2025to Sep 2026
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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: head trauma patient

Who may be able to join

  • 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 .

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Fatma Abdelhameed sedeek Khalid contact

+201125052165

fatmasedeek232@gmail.com

About this study

Official title: Assessment of Intracranial Pressure Using Optic Nerve Sheath Diameter in Head Trauma in Assiut University Emergency Department

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.

Keywords
optic nerve sheath diameter

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06726681
Study groupRoleWhat they receive
head traumaTrauma patients admitted to Emergency department with a history of acute head injury and loss of consciousness

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Optic nerve sheath diameter

    Optic nerve sheath diameter measurement inmm using ultrasound immediately before CT

    Measured: baseline

Secondary outcomes (1)
  1. Trauma severity score 2-GCS 3_outcome of patient

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2024
  2. Study startApr 2025 (estimated)
  3. Primary completionApr 2026 (estimated)
  4. Study completionSep 2026 (estimated)

Resources

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
143 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06726681
Sponsor's protocol ID
head trauma patient
Status last verified
Dec 2024
First submitted
6 Dec 2024
Last updated
10 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Head Trauma 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 1 inclusion and 2 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 10 Dec 2024. 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?

Contact Fatma Abdelhameed sedeek Khalid (+201125052165, fatmasedeek232@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Optic nerve sheath diameter (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 10 Dec 2024.

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