NCT06884319

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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
6mo left

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Mar 2025Jan 2027

Study Start

First participant enrolled

March 1, 2025

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

March 13, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 19, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2027

Expected
Last Updated

April 9, 2025

Status Verified

April 1, 2025

Enrollment Period

11 months

First QC Date

March 13, 2025

Last Update Submit

April 5, 2025

Conditions

Increase Intra Cranial PressureTraumatic Brain Injury

Keywords

Optic nerve sheat diameterDeformability indexIncrease intra cranial pressure

Outcome Measures

Primary Outcomes (1)

  • Detect increase intra cranial pressure

    By detection of increase intra cranial pressure early and rabid by Ultrasound we can treat early and avoid side effects of invasive measures

    1 week

Eligibility Criteria

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

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.

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Benha university hospital

Banhā, Egypt

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Ahmed Mostafa Abd El-hamed, Professor

    Benha University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

March 13, 2025

First Posted

March 19, 2025

Study Start

March 1, 2025

Primary Completion

January 30, 2026

Study Completion (Estimated)

January 30, 2027

Last Updated

April 9, 2025

Record last verified: 2025-04

Locations

EG(1)