The Use of Bispectral Index Monitoring to Assess Depth of Sedation in Patients With Traumatic Brain Injury

Completed

• Conditions: Traumatic Brain Injury
• Interventions: Device: BIS Monitor

• Registration Number: NCT03575169
• Lead Sponsor: University of Aberdeen

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.

Study Timeline

• Study First Submitted: 2018-06-21
• Study First Submitted QC: 2018-06-21
• Study First Posted: 2018-07-02
• Study Start: 2019-07-01
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-09
• Last Update Posted: 2023-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with TBI	BIS Monitor	Admitted to Aberdeen ICU with diagnosis of TBI and expected to require greater than 24 hours sedation.

Primary Outcome Measures

Name	Time	Method
Mean BIS	24 hours	Mean BIS of patients sedated

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Leeds Teaching Hospitals NHS Trust; 🇬🇧 Leeds, United Kingdom

NHS Lothian; 🇬🇧 Edinburgh, United Kingdom

Intensive Care Unit, Aberdeen Royal Infirmary; 🇬🇧 Aberdeen, United Kingdom

NHS Tayside; 🇬🇧 Dundee, United Kingdom