The Use of Bispectral Index Monitoring to Assess Depth of Sedation in Patients With Traumatic Brain Injury (BIS-TBI)

January 9, 2023 updated by: University of Aberdeen
An observational study to assess the BIS reported level of sedation of patients with traumatic brain injury in the ICU.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

26

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZN
        • Intensive Care Unit, Aberdeen Royal Infirmary
      • Dundee, United Kingdom
        • NHS Tayside
      • Edinburgh, United Kingdom
        • NHS Lothian
      • Leeds, United Kingdom
        • Leeds Teaching Hospitals NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with severe traumatic brain injury requiring sedation and mechanical ventilation who are admitted to Aberdeen ICU.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean BIS
Time Frame: 24 hours
Mean BIS of patients sedated
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean ICP
Time Frame: 24 hours
Mean ICP of sedated patient
24 hours
Incidence of osmotherapy use
Time Frame: 24 hours
Number of instances of osmotherapy use in sedated patients
24 hours
Vasopressor dose
Time Frame: 24 hours
Total vasopressor dose for sedated patients
24 hours
Sedative dose
Time Frame: 24 hours
Total sedative dose for sedated patients
24 hours
Length of ICU stay
Time Frame: Days to weeks
Number of days admitted to ICU
Days to weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aberdeen

Collaborators

NHS Grampian

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2019

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

June 21, 2018

First Submitted That Met QC Criteria

June 21, 2018

First Posted (Actual)

July 2, 2018

Study Record Updates

Last Update Posted (Estimate)

January 10, 2023

Last Update Submitted That Met QC Criteria

January 9, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-063-18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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