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Eye ultrasound may spot hidden brain pressure spikes after trauma

NCT ID NCT07722702

Knowledge-focused Sponsor: Benha University Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
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First seen Jul 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This study tests whether measuring the optic nerve sheath diameter — the nerve that connects the eye to the brain — with a simple bedside ultrasound can predict a dangerous rise in brain pressure when a pressure-lowering drug (mannitol) is reduced or stopped. Researchers will follow 100 adults with traumatic brain injury who are receiving mannitol, taking ultrasound measurements at several time points after the drug is weaned. The goal is to see if changes in the nerve sheath diameter can signal rebound intracranial hypertension before it becomes critical, potentially giving doctors a non-invasive early warning tool.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
optic nerve sheath diameter ultrasonography (a non-invasive ultrasound test)
What this could lead to
If the trajectory of optic nerve sheath diameter reliably predicts rebound intracranial hypertension, doctors could use a simple bedside ultrasound to catch dangerous pressure spikes early, potentially guiding safer weaning from osmotherapy.
What could go wrong
This is an observational study, not a treatment trial, so it cannot prove that using ONSD monitoring improves outcomes. The findings may not apply to all types of traumatic brain injury or to patients with eye conditions that prevent accurate measurement.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adult patients with traumatic brain injury admitted to the intensive care unit who require osmotherapy for cerebral edema management. Eligible patients will undergo serial optic nerve sheath diameter measurements and computed tomography evaluation according to the study protocol.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

brain edema Brain Injuries, Traumatic pseudotumor cerebri traumatic brain injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cerebral edema Rebound intracranial hypertension Traumatic brain injury

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Benha university hospital

    Banhā, Qalyobia, Egypt

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