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Search / Trial NCT06884319

Diagnostic Accuracy of the Optic Nerve Deformability Index and Optic Nerve Sheath Diameter as a Noninvasive Predictor of Intracranial Pressure

Launched by BENHA UNIVERSITY · Mar 13, 2025

Trial Information

Current as of May 09, 2025

Active, not recruiting

Keywords

Optic Nerve Sheat Diameter Deformability Index Increase Intra Cranial Pressure

ClinConnect Summary

This clinical trial is investigating two methods for measuring pressure inside the skull, known as intracranial pressure (ICP). Increased ICP can happen due to conditions like traumatic brain injury or bleeding in the brain, and it can be very serious. The study will include 50 patients, who will be divided into two groups: those with high ICP and those with normal levels. Researchers will use two specific tests, the Optic Nerve Sheath Diameter (ONSD) and the Optic Nerve Deformability Index (DI), to see if they can accurately predict ICP without needing invasive procedures.

To be eligible for this trial, participants must be between 18 and 65 years old and have increased ICP due to conditions like traumatic brain injury. They should also have a Glasgow Coma Scale score between 3 and 12, indicating a need for ICP monitoring. However, individuals with certain conditions, such as chronic brain issues or severe eye injuries, cannot participate. If enrolled, participants can expect to undergo non-invasive tests to measure their optic nerve and help doctors understand their intracranial pressure better. This research could lead to safer and easier ways to monitor ICP in the future.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • age 18 to 65 years
  • increased ICP (e.g., TBI, sub arachnoid hemorrhage, intracranial hemorrhage)
  • a Glasgow Coma scale=3-12 and requiring ICP monitoring via invasive methods (e.g. extra ventricular drain, lumber drain)
  • Exclusion Criteria:
  • chronic hydrocephalus
  • extensive local orbit trauma
  • a pre-existing ocular disease affecting the optic nerve and/or orbital cavity
  • hyperthyroidism with exophthalmia
  • facial trauma affecting the orbits and/or eyeballs
  • optic nerve trauma
  • signs of critically raised ICP, needing urgent surgery.
  • hemodynamically unstable between ONSD acquisition and ICP measurement.
  • receiving medication that would decrease ICP between ultrasound imaging and ICP measurement, i.e. mannitol, hypertonic saline or steroids.

About Benha University

Benha University, a leading institution in Egypt, is dedicated to advancing medical research and innovation through rigorous clinical trials. With a strong emphasis on multidisciplinary collaboration, the university aims to enhance healthcare outcomes by exploring novel therapeutic approaches and interventions. Its state-of-the-art facilities and commitment to ethical research practices ensure that all trials are conducted with the highest standards of integrity and scientific rigor. Benha University actively contributes to the global medical community by fostering partnerships and disseminating findings that can improve patient care and inform public health policies.

Locations

Benha, , Egypt

Patients applied

0 patients applied

Trial Officials

Ahmed Mostafa Abd El-hamed, Professor

Study Director

Benha University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported