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Brain wave monitor may sharpen sedation care for head injury patients

NCT ID NCT03575169

Knowledge-focused Sponsor: University of Aberdeen 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time

Summary

This observational study tests whether a bispectral index (BIS) monitor, which tracks brain activity, can reliably measure how deeply sedated patients with traumatic brain injury are in the intensive care unit. Researchers will compare BIS readings with other measures like pressure inside the skull and use of sedative drugs over 24 hours. The goal is to see if this device could help doctors fine-tune sedation for these critically ill patients.

What this could mean

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

Active substance
BIS monitor (a device that measures brain activity to assess sedation depth)
What this could lead to
If BIS monitoring proves reliable, it could help ICU teams tailor sedation more precisely for traumatic brain injury patients, potentially improving outcomes.
What could go wrong
This is a small observational study, so results may not apply broadly. BIS readings can be affected by brain injury itself, and the device may not accurately reflect sedation depth in this population.

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

26 people

The number who actually took part.

Started

Jul 2019

Finished

Dec 2022

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

Patients with severe traumatic brain injury requiring sedation and mechanical ventilation who are admitted to Aberdeen ICU.

Ages

18 years and older

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 (over 18) * Diagnosis of traumatic brain injury * Expected to survive * Expected to require greater than 24 hours of sedation and mechanical ventilation Exclusion Criteria: * Brain injury thought to be unsurvivable by ICU clinical team * Frontal decompressive craniectomy * Use of ketamine infusion at recruitment or planned use within 24 hours * Fractured frontal bone or severe overlying soft tissue injury * Simple extradural haemorrhage with no other obvious intracranial injury * Pregnant patient

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Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic traumatic brain injury

As listed by the trial registrant

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

Traumatic brain injury

Contacts and locations

Locations

  • Intensive Care Unit, Aberdeen Royal Infirmary

    Aberdeen, AB25 2ZN, United Kingdom

  • Leeds Teaching Hospitals NHS Trust

    Leeds, United Kingdom

  • NHS Lothian

    Edinburgh, United Kingdom

  • NHS Tayside

    Dundee, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.