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.
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.
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.
- Conditions
- Head Trauma 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 group | Role | What they receive |
|---|---|---|
| head trauma | Trauma 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.
Optic nerve sheath diameter
Optic nerve sheath diameter measurement inmm using ultrasound immediately before CT
Measured: baseline
Secondary outcomes (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.
- First posted10 Dec 2024
- Study startApr 2025 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head Trauma 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
- 143 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Abdelhameed sedeek khalid, Assiut University
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Intracranial Pressure Using Optic Nerve Sheath Diameter in Head Trauma in Assiut University Emergency Department
- ClinicalTrials.gov ID
- NCT06726681
- Acronym / sponsor ID
- head trauma patient
- Conditions
- Head Trauma Injury
- Keywords
- optic nerve sheath diameter
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 143 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Apr 2025 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 10 Dec 2024 (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.
Clinical performance of optic nerve sheath diameter measurement using ultrasound in comparison of CT brain to measure the intra cranial pressure in head trauma
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| head trauma | – | –Trauma patients admitted to Emergency department with a history of acute head injury and loss of consciousness |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- head trauma patient
Key inclusion criteria (1 listed)
- 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 .
Key exclusion criteria (2 listed)
- 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.
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
Optic nerve sheath diameter
Time frame: baseline
Optic nerve sheath diameter measurement inmm using ultrasound immediately before CT
1 secondary outcome
Trauma severity score 2-GCS 3_outcome of patient
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 10 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
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.