ONSD Trajectory in Rebound ICH

Sponsor
Benha University
Study ID
NCT07722702
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Cerebral Edema
  • Rebound Intracranial Hypertension
  • Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Optic Nerve Sheath Diameter Ultrasonography — DIAGNOSTIC_TEST
    Serial ultrasonographic measurement of optic nerve sheath diameter (ONSD) will be performed bilaterally using a standardized transorbital ultrasound technique immediately before osmotherapy reduction or discontinuation (baseline) and at 4, 6, 12, and 24 hours after weaning. Additional measurements may be obtained if clinical deterioration suggestive of rebound intracranial hypertension occurs. ONSD measurements are performed for observational purposes only and will not influence routine clinical management.

Study Details

The goal of this prospective observational study is to determine whether the trajectory of optic nerve sheath diameter (ONSD) after osmotherapy weaning can predict rebound intracranial hypertension in adult patients with traumatic brain injury requiring osmotherapy for elevated intracranial pressure. The main questions it aims to answer are: Does the trajectory of ONSD during osmotherapy weaning predict the development of rebound intracranial hypertension? What is the diagnostic accuracy of serial ONSD measurements for the early detection of rebound intracranial hypertension? Researchers will compare patients who develop rebound intracranial hypertension with those who do not to determine whether changes in ONSD trajectory differ significantly between the two groups. Participants will: Undergo serial bedside ocular ultrasound examinations for ONSD measurement at predefined time points after osmotherapy weaning. Receive standard clinical management for traumatic brain injury according to institutional protocols; no additional therapeutic intervention will be administered. Undergo routine neurological assessments, laboratory investigations, and neuroimaging as clinically indicated. Be followed for the occurrence of rebound intracranial hypertension and relevant clinical outcomes during their ICU stay

Key Dates

First listed
Jul 23, 2026
Start date
Sep 1, 2026
Status verified
Jul 2026
Primary completion
Sep 1, 2027
Completion
Oct 1, 2027

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: Traumatic Brain Injury Patients Undergoing Osmotherapy Weaning
    Adult patients with traumatic brain injury receiving osmotherapy for intracranial hypertension who undergo protocol-defined osmotherapy weaning. Participants will undergo serial optic nerve sheath diameter (ONSD) measurements before and after osmotherapy reduction or discontinuation and will be followed prospectively for the development of rebound intracranial hypertension and related clinical outcomes.

Primary Outcome Measure

Prediction of rebound intracranial hypertension using serial ONSD measurements [ Time Frame: Within 24 hours after osmotherapy reduction or discontinuation ]

Central Contacts

Related Studies