NCT03575169
Completed
Not Applicable
The Use of Bispectral Index Monitoring to Assess Depth of Sedation in Patients With Traumatic Brain Injury
ConditionsTraumatic Brain Injury
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Traumatic Brain Injury
- Sponsor
- University of Aberdeen
- Enrollment
- 26
- Locations
- 4
- Primary Endpoint
- Mean BIS
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Mean BIS
Time Frame: 24 hours
Mean BIS of patients sedated
Secondary Outcomes
- Incidence of osmotherapy use(24 hours)
- Mean ICP(24 hours)
- Vasopressor dose(24 hours)
- Sedative dose(24 hours)
- Length of ICU stay(Days to weeks)
Study Sites (4)
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