ONSD Trajectory in Rebound ICH
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorBenha University
About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Optic Nerve Sheath Diameter Ultrasonography
Treatment groups
100 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov