Brain NeoplasmNCT07286396
Non-invasive Intracranial Pressure Monitoring in Brain Tumor Patients
An observational study of Brain Neoplasm and Intracranial Pressure Increase, run by Tanta University at 1 site in Egypt.
Trial summary
This research protocol focuses on the pre- and post-operative evaluation of ICP using non-invasive methods, particularly in the context of surgery for brain tumor removal. By utilizing ocular ultrasound to measure ONSD and ONSD/ETD ratios, this study hypothesizes that the utility of these parameters in monitoring ICP… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Brain Neoplasm, Intracranial Pressure Increase
- What is being tested?
- Ocular Sonography
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2026to Jan 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a prospective observational study that will be conducted on 60 adult patients aged more than 21 years with ASA physical status II or IV. These patients will be admitted for brain tumor resection surgery at Tanta University Hospitals undergoing brain tumor resection surgery.
Who may be able to join
- • Adult patients (>21 years) undergoing brain tumor resection surgery.
- Preoperative imaging-confirmed diagnosis of the tumor.
- American Society of Anesthesiologists (ASA) physical status II to IV
- Consent to participate in the study.
Who cannot join
- • Preexisting ocular conditions affecting the optic nerve or globe integrity, such as glaucoma, thyroid-associated ophthalmopathy, or other optic nerve diseases.
- Combined ocular and optic nerve injuries at admission.
- History of cranial trauma, prior neurosurgery, or lumbar puncture performed within 2 weeks before the measurement of optic nerve sheath diameter (ONSD).
- History of subarachnoid hemorrhage (SAH).
- Serious complications that could affect life expectancy, such as hematological disorders or malignancies.
- Refusal to participate or withdrawal of consent at any stage.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
sameh Ahmed contact
About this study
Official title: Non-invasive Intracranial Pressure Monitoring in Brain Tumor Patients: A Prospective Observational Study of Optic Nerve Sheath Diameter Dynamics
This research protocol focuses on the pre- and post-operative evaluation of ICP using non-invasive methods, particularly in the context of surgery for brain tumor removal. By utilizing ocular ultrasound to measure ONSD and ONSD/ETD ratios, this study hypothesizes that the utility of these parameters in monitoring ICP pre- and post-operative periods could be effective.
Read the detailed description
This research protocol focuses on the pre- and post-operative evaluation of ICP using non-invasive methods, particularly in the context of brain tumor resection surgery. By utilizing ocular ultrasound to measure ONSD and ONSD/ETD ratios, this study hypothesizes that the utility of these parameters in monitoring ICP pre- and post-operative periods could be effective.
This study aims to evaluate the effectiveness of the ONSD and the ONSD/ETD ratio using ultrasound as a non-invasive method for measuring intracranial pressure pre- and post-operatively in brain tumor patients.
- Conditions
- Brain Neoplasm, Intracranial Pressure Increase
- Being tested
- Ocular Sonography
- Medical subject headings
- Brain Neoplasms, Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ocular SonographyDiagnostic test
The examination will employ an ultrasound machine with a linear probe. Patients will be positioned supine with their heads elevated at a 20-30° angle. They will be instructed to keep their eyes closed in a neutral position while suppressing voluntary eye movement.The transducer will be gently placed on the gel in the temporal region of the eyelid to avoid exerting pressure on the eye. Optic nerve sheath diameter will be measured 3 mm posterior to the optic nerve's tip, with electronic calipers used to measure the values. ONSD will be defined as the distance within the dura mater, and ETD will be measured across the maximal transverse diameter of the eyeball, from one side of the retina behind the lens to the other. Measurements will be taken in both coronal and sagittal planes by positioning the probe perpendicular (90°) to the coronal plane, ensuring optimal alignment of the optic nerve with the probe.
What is being measured
The primary outcome is the main question the study is designed to answer.
optic nerve sheath diameter dynamics
the measuremnt of optic nerve sheath diameter and optic nerve sheath diameter to transverse eyeball diamter ratio
Measured: before (in the preoperative holding area) and after the surgery (immediate, 1,2, 4, 6, and 12 hr in ICU).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study startJan 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain NeoplasmStudies of the same condition, open and under way.
- More trials run by Tanta 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, tarek abdel hay mostafa, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07286396
- Sponsor's protocol ID
- ICP measurement
- Status last verified
- Dec 2025
- First submitted
- 2 Dec 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Intracranial Pressure Monitoring in Brain Tumor Patients: A Prospective Observational Study of Optic Nerve Sheath Diameter Dynamics
- ClinicalTrials.gov ID
- NCT07286396
- Acronym / sponsor ID
- ICP measurement
- Conditions
- Brain Neoplasm, Intracranial Pressure Increase
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 16 Dec 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 research protocol focuses on the pre- and post-operative evaluation of ICP using non-invasive methods, particularly in the context of surgery for brain tumor removal. By utilizing ocular ultrasound to measure ONSD and ONSD/ETD ratios, this study hypothesizes that the utility of these parameters in monitoring ICP pre- and post-operative periods could be effective.
Detailed description
This research protocol focuses on the pre- and post-operative evaluation of ICP using non-invasive methods, particularly in the context of brain tumor resection surgery. By utilizing ocular ultrasound to measure ONSD and ONSD/ETD ratios, this study hypothesizes that the utility of these parameters in monitoring ICP pre- and post-operative periods could be effective.
This study aims to evaluate the effectiveness of the ONSD and the ONSD/ETD ratio using ultrasound as a non-invasive method for measuring intracranial pressure pre- and post-operatively in brain tumor patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a prospective observational study that will be conducted on 60 adult patients aged more than 21 years with ASA physical status II or IV. These patients will be admitted for brain tumor resection surgery at Tanta University Hospitals undergoing brain tumor resection surgery.
Key inclusion criteria (4 listed)
- • Adult patients (>21 years) undergoing brain tumor resection surgery.
Key exclusion criteria (6 listed)
- • Preexisting ocular conditions affecting the optic nerve or globe integrity, such as glaucoma, thyroid-associated ophthalmopathy, or other optic nerve diseases.
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 |
|---|---|---|
| Ocular SonographyThe examination will employ an ultrasound machine with a linear probe. Patients will be positioned supine with their heads elevated at a 20-30° angle. They will be instructed to keep their eyes closed in a neutral position while suppressing voluntary eye movement.The transducer will be gently placed on the gel in the temporal region of the eyelid to avoid exerting pressure on the eye. Optic nerve sheath diameter will be measured 3 mm posterior to the optic nerve's tip, with electronic calipers used to measure the values. ONSD will be defined as the distance within the dura mater, and ETD will be measured across the maximal transverse diameter of the eyeball, from one side of the retina behind the lens to the other. Measurements will be taken in both coronal and sagittal planes by positioning the probe perpendicular (90°) to the coronal plane, ensuring optimal alignment of the optic nerve with the probe. | Diagnostic test | – |
Primary outcome
optic nerve sheath diameter dynamics
Time frame: before (in the preoperative holding area) and after the surgery (immediate, 1,2, 4, 6, and 12 hr in ICU).
the measuremnt of optic nerve sheath diameter and optic nerve sheath diameter to transverse eyeball diamter ratio
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 16 Dec 2025.
- 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.
sameh Ahmed contact
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 Brain Neoplasm and Intracranial Pressure Increase, run by Tanta 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 4 inclusion and 6 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 16 Dec 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?
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 tarek AH Mostafa (01003591332, dr.tarek311@yahoo.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 dynamics (time frame: before (in the preoperative holding area) and after the surgery (immediate, 1,2, 4, 6, and 12 hr in ICU).). 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 16 Dec 2025.