Can a handheld ultrasound probe spot dangerous brain swelling without a CT scan?

NCT ID NCT07816588

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
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The trial has finished. Results may not be published yet.
Stopped early
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Cancelled
Cancelled before anyone took part.

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Not a trial. The treatment could once be requested outside a study, but no longer can.
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The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Sep 11, 2026 ยท Last updated Sep 11, 2026

Summary

After a traumatic brain injury, pressure can build inside the skull and cause serious harm. Doctors usually rely on a CT scan to spot this, but moving a critically ill patient to the scanner carries risks. This study tests two non-invasive ultrasound methods, transcranial Doppler and optic nerve sheath diameter measurement, to see how well they detect signs of raised pressure compared with CT. Researchers will enroll 40 adults aged 18 to 60 who are in intensive care with blunt head injury and brain swelling on their first CT scan.

What this could mean

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

Active substance
transcranial Doppler ultrasound and optic nerve sheath diameter ultrasound
What this could lead to
If the ultrasound methods prove accurate, doctors could check for rising pressure inside the skull at the bedside without moving a fragile patient to a CT scanner.
What could go wrong
The study is small, with 40 patients at one hospital, and ultrasound signals can be hard to capture through the skull. The results may not hold up in a larger or more varied group of patients.

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 40 people

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

Started

Jun 2026

Expected to finish

Dec 2026

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

The study population will consist of adult male and female patients aged 18-60 years who are admitted to the intensive care unit with blunt traumatic brain injury associated with diffuse brain edema on the initial CT brain scan. A total of 40 patients are planned for inclusion. Participants will undergo assessment using transcranial Doppler and optic nerve sheath diameter ultrasound, with comparison of these findings with CT brain findings suggestive of increased intracranial pressure.

Ages

18 to 60 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: * Inclusion Criteria: Age 18-60 years. Male and female patients. Patients admitted to the intensive care unit with blunt traumatic brain injury associated with diffuse brain edema on the initial CT brain scan. Patient or legally authorized representative provides informed consent. Exclusion Criteria: Age less than 18 or greater than 60 years. History of vascular disease affecting brain vessels. Pregnant females. Inability to obtain adequate TCD signal from trans-temporal acoustic bone windows due to fusion of skull sutures or temporal bone injury. Significant cardiovascular disease that may affect the TCD signal, such as significant arrhythmia. History of cardiac arrest before admission. Blood flow velocity greater than 120 cm/sec in patients with subarachnoid hemorrhage, to exclude vasospasm as a cause of decreased blood flow. Ocular trauma or orbital surgery that would interfere with ONSD measurement. Chronic hydrocephalus. History of Graves' disease with exophthalmos. History of disease affecting the optic nerve, such as glaucoma. Refusal of consent by the patient or legally authorized representative.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Ain-Shams University Hospitals

    Cairo, Cairo Governorate, Egypt

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