Non-invasive Intracranial Pressure Monitoring in Brain Tumor Patients

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Brain Neoplasm; Intracranial Pressure Increase
• Intervention / Treatment: Diagnostic test: Ocular Sonography

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 Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: sameh Ahmed; Email: samehabdelkhalik1982@gmail.com
• Study Contact Backup: Name: tarek AH Mostafa; Phone Number: 01003591332; Email: dr.tarek311@yahoo.com

Study Locations

• Egypt
  • El Gharbyia
    • Tanta, El Gharbyia, Egypt, 31111
      • Faculty of medicine, Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: December 2, 2025
• First Submitted That Met QC Criteria: December 2, 2025
• First Posted (Actual): December 16, 2025

Study Record Updates

• Last Update Posted (Actual): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms; Brain Neoplasms; Intracranial Hypertension
• Other Study ID Numbers: ICP measurement

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No