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Trial record 15 of 311 for:    Recruiting, Not yet recruiting, Available Studies | "Brain Injuries, Traumatic"

The Use of Bispectral Index Monitoring to Assess Depth of Sedation in Patients With Traumatic Brain Injury (BIS-TBI)

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ClinicalTrials.gov Identifier: NCT03575169
Recruitment Status : Not yet recruiting
First Posted : July 2, 2018
Last Update Posted : July 2, 2018
Sponsor:
Collaborator:
NHS Grampian
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Traumatic Brain Injury Device: BIS Monitor

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 Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Use of Bispectral Index Monitoring to Assess Depth of Sedation in Patients With Traumatic Brain Injury
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : November 1, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients with TBI
Admitted to Aberdeen ICU with diagnosis of TBI and expected to require greater than 24 hours sedation.
Device: BIS Monitor
Unilateral BIS electrode




Primary Outcome Measures :
  1. Mean BIS [ Time Frame: 24 hours ]
    Mean BIS of patients sedated


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with severe traumatic brain injury requiring sedation and mechanical ventilation who are admitted to Aberdeen ICU.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03575169


Contacts
Contact: Callum Kaye, MBChB FRCA FFIC|M 03454566000 ext 3262 callumkaye@nhs.net

Locations
United Kingdom
Intensive Care Unit, Aberdeen Royal Infirmary
Aberdeen, United Kingdom, AB25 2ZN
Sponsors and Collaborators
University of Aberdeen
NHS Grampian

Responsible Party: University of Aberdeen
ClinicalTrials.gov Identifier: NCT03575169     History of Changes
Other Study ID Numbers: 1-063-18
First Posted: July 2, 2018    Key Record Dates
Last Update Posted: July 2, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Aberdeen:
Bispectral index
Monitoring
Sedation
Traumatic Brain Injury

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System