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

NCT ID: NCT03575169

Last Updated: 2023-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-01

Study Completion Date

2022-12-31

Brief Summary

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An observational study to assess the BIS reported level of sedation of patients with traumatic brain injury in the ICU.

Detailed Description

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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.

Conditions

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Traumatic Brain Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with TBI

Admitted to Aberdeen ICU with diagnosis of TBI and expected to require greater than 24 hours sedation.

BIS Monitor

Intervention Type DEVICE

Unilateral BIS electrode

Interventions

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BIS Monitor

Unilateral BIS electrode

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NHS Grampian

OTHER_GOV

Sponsor Role collaborator

University of Aberdeen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Intensive Care Unit, Aberdeen Royal Infirmary

Aberdeen, , United Kingdom

Site Status

NHS Tayside

Dundee, , United Kingdom

Site Status

NHS Lothian

Edinburgh, , United Kingdom

Site Status

Leeds Teaching Hospitals NHS Trust

Leeds, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 38868457 (View on PubMed)

Other Identifiers

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1-063-18

Identifier Type: -

Identifier Source: org_study_id

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