Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-28 @ 6:00 AM
Study NCT ID:
NCT03575169
Status:
COMPLETED
Last Update Posted:
2023-01-10
First Post:
2018-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of Bispectral Index Monitoring to Assess Depth of Sedation in Patients With Traumatic Brain Injury
Sponsor:
University of Aberdeen
Organization:
Study Overview
Official Title:
The Use of Bispectral Index Monitoring to Assess Depth of Sedation in Patients With Traumatic Brain Injury
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BIS-TBI
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.
All clinical care is at the discretion of the clinical team.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: