UltrasoundNCT06993961
Ultrasound Measurement of Optic Nerve Sheath Diameter as Non-Invasive Detector of Raised Intracranial Pressure in Adult Traumatic and Non-Traumatic Neurocritical Patients in ICU
An observational study of Ultrasound and Optic Nerve Sheath Diameter, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study aimed to assess the role of ultrasound as a non-invasive method (bedside) to measure the rise of intracranial pressure by measuring the optic nerve sheath diameter in traumatic and nontraumatic neurocritical patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ultrasound, Optic Nerve Sheath Diameter, Non-Invasive
- What is being tested?
- Ultrasound
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2022to 1 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This observational prospective trial involved 50 cases aged >18 years old, both sexes, presenting with suspected high intracranial pressure (ICP). The study was conducted from August 2022 to July 2023 after approval from the Ethical Committee of Ain Shams University Hospitals, Cairo, Egypt.
Who may be able to join
- Age >18 years old.
- Both sexes.
- Patients with suspected high intracranial pressure.
Who cannot join
- Cases suffering from eye disease or optic nerve problems (Glaucoma, optic Nerve Tumor, Neuritis, Orbital Fracture).
- Patients suffering from mental illness render them incapable of communication \& cooperation (For Example: Dementia and irritability).
- Any previous intensive care surgeries \& hyperthyroidism (due to exophthalmos)
Trial locations and contacts
1 site in 1 country.
About this study
This study aimed to assess the role of ultrasound as a non-invasive method (bedside) to measure the rise of intracranial pressure by measuring the optic nerve sheath diameter in traumatic and nontraumatic neurocritical patients.
Read the detailed description
Measurement of intracranial pressure (ICP) is crucial in the management of many neurological conditions. However, due to the invasiveness, high cost, and required expertise of available ICP monitoring techniques, many patients who could benefit from it do not receive it. As a result, a substantial effort has been made to explore and develop novel non-invasive ICP monitoring techniques to improve the overall clinical care of patients suffering from ICP disorders.
- Conditions
- Ultrasound, Optic Nerve Sheath Diameter, Non-Invasive, Intracranial Pressure, Neurocritical, Intensive Care Unit
- Being tested
- Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
Ultrasound (US) measurement of optic nerve sheath diameter (ONSD) was performed.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Patient with suspected high intracranial pressure (ICP) as determined by initial computed tomography (CT) brain. Receives: Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracranial Pressure
Non-invasive bedside intracranial pressure (ICP) assessment via ultrasound (US) measurement of optic nerve sheath diameter (ONSD).
Measured: 24 hours post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start1 Aug 2022
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UltrasoundStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kareem Elsaeed abdelwahab, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06993961
- Sponsor's protocol ID
- MD 265/2022
- Status last verified
- May 2025
- First submitted
- 20 May 2025
- Last updated
- 29 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Measurement of Optic Nerve Sheath Diameter as Non-Invasive Detector of Raised Intracranial Pressure in Adult Traumatic and Non-Traumatic Neurocritical Patients in ICU
- ClinicalTrials.gov ID
- NCT06993961
- Acronym / sponsor ID
- MD 265/2022
- Conditions
- Ultrasound, Optic Nerve Sheath Diameter, Non-Invasive, Intracranial Pressure, Neurocritical, Intensive Care Unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 29 May 2025 (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.
This study aimed to assess the role of ultrasound as a non-invasive method (bedside) to measure the rise of intracranial pressure by measuring the optic nerve sheath diameter in traumatic and nontraumatic neurocritical patients.
Detailed description
Measurement of intracranial pressure (ICP) is crucial in the management of many neurological conditions. However, due to the invasiveness, high cost, and required expertise of available ICP monitoring techniques, many patients who could benefit from it do not receive it. As a result, a substantial effort has been made to explore and develop novel non-invasive ICP monitoring techniques to improve the overall clinical care of patients suffering from ICP disorders.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Device: UltrasoundPatient with suspected high intracranial pressure (ICP) as determined by initial computed tomography (CT) brain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This observational prospective trial involved 50 cases aged >18 years old, both sexes, presenting with suspected high intracranial pressure (ICP). The study was conducted from August 2022 to July 2023 after approval from the Ethical Committee of Ain Shams University Hospitals, Cairo, Egypt.
Key inclusion criteria (3 listed)
- Age >18 years old.
- Both sexes.
- Patients with suspected high intracranial pressure.
Key exclusion criteria (3 listed)
- Cases suffering from eye disease or optic nerve problems (Glaucoma, optic Nerve Tumor, Neuritis, Orbital Fracture).
- Patients suffering from mental illness render them incapable of communication \& cooperation (For Example: Dementia and irritability).
- Any previous intensive care surgeries \& hyperthyroidism (due to exophthalmos)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasoundUltrasound (US) measurement of optic nerve sheath diameter (ONSD) was performed. | Device | Study group |
Primary outcome
Intracranial Pressure
Time frame: 24 hours post-procedure
Non-invasive bedside intracranial pressure (ICP) assessment via ultrasound (US) measurement of optic nerve sheath diameter (ONSD).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ultrasound and Optic Nerve Sheath Diameter, run by Ain Shams University at 1 site in Egypt.
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: finished, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Intracranial Pressure (time frame: 24 hours post-procedure). 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 29 May 2025.