NCT06726681

Brief Summary

Clinical performance of optic nerve sheath diameter measurement using ultrasound in comparison of CT brain to measure the intra cranial pressure in head trauma

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
143

participants targeted

Target at P50-P75 for all trials

Timeline
4mo left

Started Apr 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress78%
Apr 2025Sep 2026

First Submitted

Initial submission to the registry

December 6, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 10, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

December 10, 2024

Status Verified

December 1, 2024

Enrollment Period

1 year

First QC Date

December 6, 2024

Last Update Submit

December 6, 2024

Conditions

Keywords

optic nerve sheath diameter

Outcome Measures

Primary Outcomes (1)

  • Optic nerve sheath diameter

    Optic nerve sheath diameter measurement inmm using ultrasound immediately before CT

    baseline

Secondary Outcomes (1)

  • Trauma severity score 2-GCS 3_outcome of patient

    baseline

Study Arms (1)

head trauma

Trauma patients admitted to Emergency department with a history of acute head injury and loss of consciousness

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

head trauma patient

You may qualify if:

  • Patients aged from \> 18 years old. Both male and female patients. GCS\<15 post injury or pt sent to CT scan by neurosurgery for Intracranial injury's Patients with no past or current neurological or neuro-ophthalmological diseases and normal neurological exams .

You may not qualify if:

  • Pregnant women. Patients with severe orbital trauma. penetrating eye injury, or other ocular pathologies such as glaucoma, optic neuritis, central retinal vein/artery occlusion, retrobulbar hematoma or orbital cellulitis.
  • Patient with preexisting neurological diseases. Blind patients. Patients with cardiac arrest . Patients who refused participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Fatma Abdelhameed sedeek Khalid

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assessment of intracranial pressure using optic nerve sheath diameter in head trauma in Assiut University Emergency department

Study Record Dates

First Submitted

December 6, 2024

First Posted

December 10, 2024

Study Start

April 1, 2025

Primary Completion

April 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

December 10, 2024

Record last verified: 2024-12