The Use of Bispectral Index Monitoring to Assess Depth of... | NCT03575169

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

NCT03575169

Sponsor

University of Aberdeen

Status

Completed

Last Update Posted

Jan 10, 2023Actual

Enrollment

26Actual

Phase

Not provided

Conditions

Traumatic Brain Injury

Interventions

BIS Monitor

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2019Actual

Primary Completion Date

Dec 31, 2022Actual

Completion Date

Dec 31, 2022Actual

First Submitted Date

Jun 21, 2018

First Submission Date that Met QC Criteria

Jun 21, 2018

First Posted Date

Jul 2, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 9, 2023

Last Update Posted Date

Jan 10, 2023Actual

Name	Class
NHS Grampian	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

26Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with TBI		Admitted to Aberdeen ICU with diagnosis of TBI and expected to require greater than 24 hours sedation.	Device: BIS Monitor

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BIS Monitor	Device	Unilateral BIS electrode	Patients with TBI

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Mean ICP	Mean ICP of sedated patient	24 hours
Incidence of osmotherapy use	Number of instances of osmotherapy use in sedated patients

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Intensive Care Unit, Aberdeen Royal Infirmary		Aberdeen		AB25 2ZN	United Kingdom
NHS Tayside

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38868457	Derived	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.

Type	Date	Date Unknown
Release	Apr 30, 2026
Reset	May 26, 2026
Release	May 27, 2026
Reset	Jun 22, 2026

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Apr 30, 2026			May 26, 2026
May 27, 2026

ID	Term
D001930	Brain Injuries
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases