BIS-TBI (England)

  • Research type

    Research Study

  • Full title

    The use of Bispectral Index monitoring to assess depth of sedation in patients with traumatic brain injury (BIS-TBI)

  • IRAS ID

    301419

  • Contact name

    Callum T Kaye

  • Contact email

    callum.kaye@nhs.scot

  • Sponsor organisation

    NHS Grampian

  • Clinicaltrials.gov Identifier

    NCT03575169

  • Duration of Study in the UK

    1 years, 0 months, 31 days

  • Research summary

    Research Summary:

    Patients with severe Traumatic Brain Injury (TBI) often require mechanical ventilation and sedation to prevent secondary brain injury. To date there remains no recommendation regarding the appropriate depth of sedation.
    Current practice in UK ICUs involves clinical evaluation to assess depth of sedation. Bispectral Index (BIS) is a well- established, non-invasive method of assessing depth of anaesthesia, although it is not routinely used in UK ICUs.

    This observational study aims to use BIS to:
    • Assess the level of sedation of TBI patients
    • Describe the sedation practice for TBI patients
    • Assess if BIS-predicted depth of anaesthesia is associated with other factors such as: o Vasoactive medication use
    o Osmotherapy use

    Summary of Results:

    We found that the level of sedation, as assessed by a bedside nurse using the usually recognised scales, was a poor reflection of the underlying brain activity. Additionally, we found that the level of brain activity was a poor indicator of the need for further treatments to manage brain swelling. These findings suggest that if sedation is beneficial to prevent worsening brain injury by reducing brain activity, then a strategy using brain monitoring may be more effective than nurse assessments. Additionally, it suggests that sedation is not as beneficial as many people believe it is for preventing brain swelling after a severe injury.

  • REC name

    Yorkshire & The Humber - Bradford Leeds Research Ethics Committee

  • REC reference

    21/YH/0131

  • Date of REC Opinion

    14 Jul 2021

  • REC opinion

    Further Information Favourable Opinion