Traumatic Brain InjuryBIS-TBINCT03575169
The Use of Bispectral Index Monitoring to Assess Depth of Sedation in Patients With Traumatic Brain Injury
An observational study of Traumatic Brain Injury, run by University of Aberdeen at 4 sites in United Kingdom.
Trial summary
An observational study to assess the BIS reported level of sedation of patients with traumatic brain injury in the ICU. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- BIS Monitor
- Type of treatment
- Medical device
- How many people
- 26 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 1 Jul 2019to 31 Dec 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with severe traumatic brain injury requiring sedation and mechanical ventilation who are admitted to Aberdeen ICU.
Who may be able to join
- Adults (over 18)
- Diagnosis of traumatic brain injury
- Expected to survive
- Expected to require greater than 24 hours of sedation and mechanical ventilation
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Intensive Care Unit, Aberdeen Royal Infirmary
Aberdeen, AB25 2ZN
NHS Tayside
Dundee
NHS Lothian
Edinburgh
Leeds Teaching Hospitals NHS Trust
Leeds
About this study
An observational study to assess the BIS reported level of sedation of patients with traumatic brain injury in the ICU.
Read the detailed description
Patients admitted to Aberdeen ICU with severe traumatic brain injury will have a BIS electrode placed and observed for 24 hours. The study team will be blinded to the result, so not to influence treatment.
All clinical care is at the discretion of the clinical team.
- Conditions
- Traumatic Brain Injury
- Being tested
- BIS Monitor
- Keywords
- Bispectral index, Monitoring, Sedation, Traumatic Brain Injury
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIS MonitorDevice
Unilateral BIS electrode
| Study group | Role | What they receive |
|---|---|---|
| Patients with TBI | Admitted to Aberdeen ICU with diagnosis of TBI and expected to require greater than 24 hours sedation. Receives: Device: BIS Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean BIS for Population Over 24 Hours
Mean BIS of patients sedated. BIS is a processed EEG value ranging from 0 to 100, with lower values representing decreased brain activity. The usual range for General Anaesthesia is 40-60.
Measured: 24 hours
Secondary outcomes (5)
Mean ICP for Population Over 24 Hours
Mean ICP of sedated patients
Measured: 24 hours
Incidence of Osmotherapy Use for Population Over 24 Hours
Number of instances of osmotherapy use in sedated patients
Measured: 24 hours
Median Vasopressor Dose for Population Over 24 Hours
Total vasopressor dose for sedated patients
Measured: 24 hours
Sedative Dose for Population Over 24 Hours
Total sedative dose for sedated patients
Measured: 24 hours
Length of ICU Stay for Population Over 24 Hours
Number of days admitted to ICU
Measured: Days to weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2018
- Study start1 Jul 2019
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Grampian
- Responsible party
- Sponsor
- Investigators
- Callum NA Kaye, MBChB, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03575169
- Sponsor's protocol ID
- 1-063-18
- Acronym
- BIS-TBI
- Status last verified
- Jan 2023
- First submitted
- 21 Jun 2018
- Last updated
- 10 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kaye C, Rhodes J, Austin P, Casey M, Gould R, Sira J, Treweek S, MacLennan G. Assessment of depth of sedation using Bispectral Index monitoring in patients with severe traumatic brain injury in UK intensive care units. BJA Open. 2024 May 28;10:100287. doi: 10.1016/j.bjao.2024.100287. eCollection 2024 Jun.
PubMed 38868457
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Bispectral Index Monitoring to Assess Depth of Sedation in Patients With Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT03575169
- Acronym / sponsor ID
- BIS-TBI / 1-063-18
- Conditions
- Traumatic Brain Injury
- Keywords
- Bispectral index, Monitoring, Sedation, Traumatic Brain Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Collaborators
- NHS Grampian
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 2 Jul 2018 (actual)
- Results
- Posted 10 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An observational study to assess the BIS reported level of sedation of patients with traumatic brain injury in the ICU.
Detailed description
Patients admitted to Aberdeen ICU with severe traumatic brain injury will have a BIS electrode placed and observed for 24 hours. The study team will be blinded to the result, so not to influence treatment.
All clinical care is at the discretion of the clinical team.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with TBI | – | Device: BIS MonitorAdmitted to Aberdeen ICU with diagnosis of TBI and expected to require greater than 24 hours sedation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe traumatic brain injury requiring sedation and mechanical ventilation who are admitted to Aberdeen ICU.
Key inclusion criteria (4 listed)
- Adults (over 18)
- Diagnosis of traumatic brain injury
- Expected to survive
- Expected to require greater than 24 hours of sedation and mechanical ventilation
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIS MonitorUnilateral BIS electrode | Device | Patients with TBI |
Primary outcome
Mean BIS for Population Over 24 Hours
Time frame: 24 hours
Mean BIS of patients sedated. BIS is a processed EEG value ranging from 0 to 100, with lower values representing decreased brain activity. The usual range for General Anaesthesia is 40-60.
5 secondary outcomes
Mean ICP for Population Over 24 Hours
Time frame: 24 hours
Incidence of Osmotherapy Use for Population Over 24 Hours
Time frame: 24 hours
Median Vasopressor Dose for Population Over 24 Hours
Time frame: 24 hours
Sedative Dose for Population Over 24 Hours
Time frame: 24 hours
Length of ICU Stay for Population Over 24 Hours
Time frame: Days to weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 38868457Kaye C, Rhodes J, Austin P, Casey M, Gould R, Sira J, Treweek S, MacLennan G. Assessment of depth of sedation using Bispectral Index monitoring in patients with severe traumatic brain injury in UK intensive care units. BJA Open. 2024 May 28;10:100287. doi: 10.1016/j.bjao.2024.100287. eCollection 2024 Jun.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Callum NA Kaye, MBChB principal investigator
Study Principal Investigator
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury, run by University of Aberdeen at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean BIS for Population Over 24 Hours (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03575169, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.