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Eye ultrasound could replace needles for measuring brain pressure in kids

NCT ID NCT01796015

Diagnosis Sponsor: Hospices Civils de Lyon Source: ClinicalTrials.gov ↗

What the study statuses mean

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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.
Ongoing
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
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
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tested whether an ultrasound of the optic nerve sheath (the lining around the nerve connecting the eye to the brain) can accurately detect dangerously high pressure inside the skull in children. Researchers measured the nerve sheath diameter in 230 children with brain injuries and compared it to the standard invasive pressure monitor. The goal is to find a safer, non-invasive way to spot this life-threatening condition early.

What this could mean

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

Active substance
ultrasound measurement of optic nerve sheath diameter
What this could lead to
If successful, this could provide a non-invasive way to detect dangerous brain pressure in children, reducing the need for risky invasive monitors.
What could go wrong
This is a completed diagnostic accuracy study, not a treatment trial. The ultrasound method may not be precise enough to replace standard invasive monitoring in all cases.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

230 people

The number who actually took part.

Start date

Apr 2011

Finished

Feb 2017

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.

Ages

2 months to 16 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: For the 97 patients: * children from 2 months to 16 years * in the intensive care unit * TBI : moderate (GCS between 9 and 12) to severe (GCS \<9), whatever the mechanism involved * informed consent form signed by parents Non inclusion Criteria: * obesity (BMI \> 97th percentile for the age) * patient already under replacement therapy. * patient taking AEDs * patient with long-term systemic corticosteroid therapy * history of neurological disease or learning difficulties * no covered by a national health insurance

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Conditions

The condition(s) this trial relates to.

cerebral infarction cerebral sinovenous thrombosis intracranial thrombosis stroke disorder traumatic brain injury

As listed by the trial registrant

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

Cerebral stroke Cerebral venous thrombosis

Contacts and locations

Locations

  • Pediatric Critical Care Unit, CHU La Tronche

    Grenoble, France

  • Pediatric Critical Care Unit, Hôpital Femme Mère Enfant ,Hospices Civils de Lyon

    Bron, Auvergne-Rhône-Alpes, 69677, France

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