Recruiting

Observational Study

Sponsor:

University of Manitoba

Code:

NCT02810145

Conditions

Brain Injuries

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

We will determine the incidence and magnitude of cerebral desaturation in TBI. Adult patients (18 years and older) admitted to the Surgical/Trauma Intensive Care Unit (ICU) at the Health Sciences Center with a severe TBI will have cerebral oximetry monitoring instituted within 12 hours of admission and continuing for 72 hours after placement. Decreases in regional cerebral oxygenation will be correlated with ICU hemodynamic parameters including mean arterial pressure, intracranial pressure, and arterial oxygen and carbon dioxide tension.

Conditions

Brain Injuries

Study ID

NCT02810145

Start date

Jul, 2016

Status verified date

Oct, 2016

Completion date

Dec, 2019

Anticipated

Primary completion date

Aug, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adults 18 years of age or older admitted to ICU with severe TBI (Glasgow coma score <or=8)

Exclusion Criteria:

  • None

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

TBI with GCS <or= 8

Adult patients admitted to the surgical intensive care unit with traumatic brain injury and a Glasgow coma score less than or equal to 8.

Primary outcome measure

  • Incidence of cerebral desaturation [ Time Frame: 72 hours ]
  • Magnitude of cerebral desaturation [ Time Frame: 72 hours ]

Central Contacts and Locations

Central contacts

Duane J. Funk, MD

204 787-1414duane.funk@umanitoba.ca

Locations

University of Manitoba

Recruiting

Winnipeg, Manitoba, Canada, R3T2N2

Contacts

Duane J Funk, MD

204-787-1414funk@cc.umanitoba.ca

Duane Funk

204-787-1414funk@cc.umanitoba.ca

Principal Investigator:

Duane J Funk, MD

More Information

Sponsor

University of Manitoba

Last update posted

Oct 12, 2016

Last verified

Oct, 2016

Keywords

  • traumatic brain injury
  • cerebral desaturation
  • intensive care
  • hemodynamics
  • Loss
  • Consciousness

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Manitoba on 2016-10-12.