Non-invasive Intracranial Pressure Monitoring in Brain Tumor Patients

NCT ID: NCT07286396

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-31

Study Completion Date

2027-01-31

Brief Summary

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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

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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

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Brain Neoplasm Intracranial Pressure Increase

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Ocular Sonography

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* • 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.

Exclusion Criteria

* • 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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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tarek abdel hay mostafa

principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of medicine, Tanta university

Tanta, El Gharbyia, Egypt

Site Status

Countries

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Egypt

Central Contacts

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tarek AH Mostafa

Role: CONTACT

01003591332

sameh Ahmed

Role: CONTACT

Other Identifiers

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ICP measurement

Identifier Type: -

Identifier Source: org_study_id