Non-invasive Intracranial Pressure Monitoring in Brain Tumor Patients

NCT07286396 | Not Yet Recruiting DMC

• 1 other identifier: ICP measurement
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 pre- and post-operative periods could be effective.

Conditions

Brain Neoplasm; Intracranial Pressure Increase

Outcome Measures

Primary Outcomes (1)

• optic nerve sheath diameter dynamics

  the measuremnt of optic nerve sheath diameter and optic nerve sheath diameter to transverse eyeball diamter ratio

  before (in the preoperative holding area) and after the surgery (immediate, 1,2, 4, 6, and 12 hr in ICU).

Interventions

Ocular Sonography DIAGNOSTIC_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.

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of medicine, Tanta university

Tanta, El Gharbyia, 31111, Egypt

Location

MeSH Terms

Conditions

Brain Neoplasms; Intracranial Hypertension

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

tarek AH Mostafa

CONTACT

01003591332; dr.tarek311@yahoo.com

sameh Ahmed

CONTACT

samehabdelkhalik1982@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 16, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

EG (1)