Traumatic Brain Injury
Conditions
Keywords
Bispectral index, Monitoring, Sedation, Traumatic Brain Injury
Brief summary
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.
Interventions
DEVICEBIS Monitor
Unilateral BIS electrode
Sponsors
University of Aberdeen
NHS Grampian
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean BIS for Population Over 24 Hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean ICP for Population Over 24 Hours | 24 hours | Mean ICP of sedated patients |
| Incidence of Osmotherapy Use for Population Over 24 Hours | 24 hours | Number of instances of osmotherapy use in sedated patients |
| Median Vasopressor Dose for Population Over 24 Hours | 24 hours | Total vasopressor dose for sedated patients |
| Sedative Dose for Population Over 24 Hours | 24 hours | Total sedative dose for sedated patients |
| Length of ICU Stay for Population Over 24 Hours | Days to weeks | Number of days admitted to ICU |
Countries
United Kingdom
Contacts
PRINCIPAL_INVESTIGATORCallum NA Kaye, MBChB
Study Principal Investigator
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 41 years |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 4 / 26 |
| other Total, other adverse events | 0 / 26 |
| serious Total, serious adverse events | 0 / 26 |
Outcome results
None listed