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NCT Number: NCT07286396

Non-invasive Intracranial Pressure Monitoring in Brain Tumor Patients

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of medicine, Tanta university

Tanta, El Gharbyia, 31111, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

sameh Ahmed

CONTACT

[email protected]

tarek AH Mostafa

CONTACT

[email protected]

01003591332

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Non-invasive Intracranial Pressure Monitoring in Brain Tumor Patients: A Prospective Observational Study of Optic Nerve Sheath Diameter Dynamics

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Dec 16, 2025
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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