The Use of Bispectral Index Monitoring to Assess Depth of Sedation in Patients With Traumatic Brain Injury (BIS-TBI)
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|ClinicalTrials.gov Identifier: NCT03575169|
Recruitment Status : Not yet recruiting
First Posted : July 2, 2018
Last Update Posted : July 2, 2018
|Condition or disease||Intervention/treatment|
|Traumatic Brain Injury||Device: BIS Monitor|
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 Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||The Use of Bispectral Index Monitoring to Assess Depth of Sedation in Patients With Traumatic Brain Injury|
|Estimated Study Start Date :||October 1, 2018|
|Estimated Primary Completion Date :||October 1, 2019|
|Estimated Study Completion Date :||November 1, 2019|
Patients with TBI
Admitted to Aberdeen ICU with diagnosis of TBI and expected to require greater than 24 hours sedation.
Device: BIS Monitor
Unilateral BIS electrode
- Mean BIS [ Time Frame: 24 hours ]Mean BIS of patients sedated
- Mean ICP [ Time Frame: 24 hours ]Mean ICP of sedated patient
- Incidence of osmotherapy use [ Time Frame: 24 hours ]Number of instances of osmotherapy use in sedated patients
- Vasopressor dose [ Time Frame: 24 hours ]Total vasopressor dose for sedated patients
- Sedative dose [ Time Frame: 24 hours ]Total sedative dose for sedated patients
- Length of ICU stay [ Time Frame: Days to weeks ]Number of days admitted to ICU
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03575169
|Contact: Callum Kaye, MBChB FRCA FFIC|M||03454566000 ext firstname.lastname@example.org|
|Intensive Care Unit, Aberdeen Royal Infirmary|
|Aberdeen, United Kingdom, AB25 2ZN|