Optic Nerve Sheath Diameter Trajectory During Osmotherapy Weaning as a Predictor of Rebound Intracranial Hypertension in Traumatic Brain Injury
| Registry | NCT07722702, acronym ONSD/ INH |
|---|---|
| Status | Not yet recruiting |
| Study type | Observational |
| Enrollment | 100 (Estimated) |
| Sponsor | Benha University (Other) |
| Conditions | Traumatic Brain Injury, Rebound Intracranial Hypertension, Cerebral Edema |
| Interventions | Optic Nerve Sheath Diameter Ultrasonography (Diagnostic test) |
| Dates | start 2026-09-01 (estimated), primary completion 2027-09-01 (estimated), completion 2027-10-01 (estimated), first posted 2026-07-23, last updated 2026-07-23 |
| Locations | 1 site in Egypt |
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All trials for Traumatic Brain Injury All trials for Rebound Intracranial Hypertension All trials of Optic Nerve Sheath Diameter Ultrasonography
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
Traumatic brain injury (TBI) is a major cause of morbidity and mortality worldwide. Cerebral edema and elevated intracranial pressure (ICP) are common secondary complications that require prompt management to prevent further neurological injury. Osmotherapy with hypertonic saline or mannitol is routinely used to reduce ICP; however, withdrawal or weaning of osmotherapy may be associated with rebound intracranial hypertension, which can worsen neurological outcomes if not recognized early.
Optic nerve sheath diameter (ONSD), measured by bedside ocular ultrasonography, is a non-invasive surrogate marker of raised intracranial pressure. Although ONSD has been shown to correlate with ICP in several clinical settings, the predictive value of serial ONSD measurements during osmotherapy weaning for identifying rebound intracranial hypertension has not been adequately investigated.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Traumatic Brain Injury Patients Undergoing Osmotherapy Weaning | Diagnostic Test: Optic Nerve Sheath Diameter Ultrasonography | 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. |
Sex: All, ages: 18 Years to 80 Years
Inclusion Criteria: * Adults (≥18 years) with blunt traumatic brain injury admission GCS ≤12 * (or GCS 13-15 with CT signs of elevated ICP including midline shift ≥5 mm, effaced cisterns, or significant cerebral edema) * clinical decision to initiate 20% mannitol osmotherapy Exclusion Criteria: * Ocular conditions precluding ONSD measurement (glaucoma, prior ocular surgery, * globe or optic nerve trauma, * periorbital edema, orbital masses, optic nerve sheath cysts); * planned decompressive surgery or evacuation of mass lesion within 48 hours; limitation of life-sustaining therapy; pregnancy; contraindications to mannitol (baseline sodium >155 mEq/L, osmolality >320 mOsm/kg, eGFR <30 mL/min); penetrating TBI; or concurrent spinal cord injury with shock.
| Facility | City | Country | Status |
|---|---|---|---|
| Benha university hospital | Banhā, Qalyobia | Egypt |