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

U

University of Aberdeen

Status

Completed

Conditions

Traumatic Brain Injury

Treatments

Device: BIS Monitor

Study type

Observational

Funder types

Other

Identifiers

NCT03575169
1-063-18

Details and patient eligibility

About

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

Full 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.

Enrollment

26 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

26 participants in 1 patient group

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

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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