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Completed

NCT Number: NCT03575169

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

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

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Intensive Care Unit, Aberdeen Royal Infirmary, Aberdeen, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BIS monitor

Device

Unilateral BIS electrode

Primary outcomes

  1. Mean BIS

    Time frame: 24 hours

    Mean BIS of patients sedated

Secondary outcomes

  1. Mean ICP

    Time frame: 24 hours

    Mean ICP of sedated patient

  2. Incidence of osmotherapy use

    Time frame: 24 hours

    Number of instances of osmotherapy use in sedated patients

  3. Vasopressor dose

    Time frame: 24 hours

    Total vasopressor dose for sedated patients

  4. Sedative dose

    Time frame: 24 hours

    Total sedative dose for sedated patients

  5. Length of ICU stay

    Time frame: Days to weeks

    Number of days admitted to ICU

Sponsors and collaborators

Lead sponsor

University of Aberdeen

Other

Collaborators

  • NHS Grampian

Registry information

Acronym: BIS-TBI

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jul 2, 2018
Registry last updated
Jan 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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