The Use of Bispectral Index Monitoring to Assess Depth of Sedation in Patients With Traumatic Brain Injury
BIS-TBI
1 other identifier
observational
26
1 country
4
Brief Summary
An observational study to assess the BIS reported level of sedation of patients with traumatic brain injury in the ICU.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2019
Typical duration for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 21, 2018
CompletedFirst Posted
Study publicly available on registry
July 2, 2018
CompletedStudy Start
First participant enrolled
July 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedJanuary 10, 2023
January 1, 2023
3.5 years
June 21, 2018
January 9, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean BIS
Mean BIS of patients sedated
24 hours
Secondary Outcomes (5)
Mean ICP
24 hours
Incidence of osmotherapy use
24 hours
Vasopressor dose
24 hours
Sedative dose
24 hours
Length of ICU stay
Days to weeks
Study Arms (1)
Patients with TBI
Admitted to Aberdeen ICU with diagnosis of TBI and expected to require greater than 24 hours sedation.
Interventions
Eligibility Criteria
Patients with severe traumatic brain injury requiring sedation and mechanical ventilation who are admitted to Aberdeen ICU.
You may qualify if:
- Adults (over 18)
- Diagnosis of traumatic brain injury
- Expected to survive
- Expected to require greater than 24 hours of sedation and mechanical ventilation
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aberdeenlead
- NHS Grampiancollaborator
Study Sites (4)
Intensive Care Unit, Aberdeen Royal Infirmary
Aberdeen, AB25 2ZN, United Kingdom
NHS Tayside
Dundee, United Kingdom
NHS Lothian
Edinburgh, United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom
Related Publications (1)
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.
PMID: 38868457DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2018
First Posted
July 2, 2018
Study Start
July 1, 2019
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
January 10, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share