CompletedNot Applicable

The Use of Bispectral Index Monitoring to Assess Depth of Sedation in Patients With Traumatic Brain Injury

United Kingdom26 participantsStarted 2019-07-01

Plain-language summary

An observational study to assess the BIS reported level of sedation of patients with traumatic brain injury in the ICU.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean BIS for Population Over 24 Hours

Timeframe: 24 hours

Trial details

NCT IDNCT03575169

SponsorUniversity of Aberdeen

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-12-31

Results submitted2026-04-30

View on ClinicalTrials.gov More Traumatic Brain Injury trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.