Status:
ACTIVE_NOT_RECRUITING
Diagnostic Accuracy of the Optic Nerve Deformability Index and Optic Nerve Sheath Diameter as a Noninvasive Predictor of Intracranial Pressure
Lead Sponsor:
Benha University
Conditions:
Increase Intra Cranial Pressure
Traumatic Brain Injury
Eligibility:
All Genders
18-65 years
Brief Summary
The study will be carried out on 50 patients, dichotomized into high and normal ICP groups, and we will assess both ONSD and DI in all patients.
Detailed Description
Operational Design: Preparation: Awake and alert patients should be briefed on the procedure. Obtunded, intubated, or heavily sedated patients should undergo a basic eye evaluation for signs and sym...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 30 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06884319
Start Date
March 1 2025
End Date
January 30 2027
Last Update
April 9 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Benha university hospital
Banhā, Egypt