NCT02810145

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 22, 2016

Completed
9 days until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

October 12, 2016

Status Verified

October 1, 2016

Enrollment Period

2.1 years

First QC Date

June 20, 2016

Last Update Submit

October 11, 2016

Conditions

Brain Injuries

Keywords

traumatic brain injurycerebral desaturationintensive carehemodynamicsLossConsciousness

Outcome Measures

Primary Outcomes (2)

  • Incidence of cerebral desaturation

    The frequency of cerebral desaturation from time of admission to 72 hours post admission to ICU as measured by rSO2 output from cerebral oximetry.

    72 hours

  • Magnitude of cerebral desaturation

    The magnitude of cerebral desaturation from time of admission to 72 hours post admission to ICU as measured by rSO2 output from cerebral oximetry.

    72 hours

Secondary Outcomes (4)

  • Association between cerebral desaturation and intracranial pressure

    72 hours

  • Association between cerebral desaturation and mean arterial pressure

    72 hours

  • Association between cerebral desaturation and arterial oxygenation

    72 hours

  • Association between cerebral desaturation and arterial carbon dioxide concentration

    72 hours

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients admitted to the Surgical/Trauma ICU at Health Sciences Centre, Winnipeg with a severe TBI (Glasgow coma score \< or = 8).

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Manitoba

Winnipeg, Manitoba, R3T2N2, Canada

RECRUITING

Related Publications (4)

  • Fischer GW. Recent advances in application of cerebral oximetry in adult cardiovascular surgery. Semin Cardiothorac Vasc Anesth. 2008 Mar;12(1):60-9. doi: 10.1177/1089253208316443. Epub 2008 Apr 7.

    PMID: 18397905BACKGROUND

  • Casati A, Fanelli G, Pietropaoli P, Proietti R, Tufano R, Danelli G, Fierro G, De Cosmo G, Servillo G; Collaborative Italian Study Group on Anesthesia in Elderly Patients. Continuous monitoring of cerebral oxygen saturation in elderly patients undergoing major abdominal surgery minimizes brain exposure to potential hypoxia. Anesth Analg. 2005 Sep;101(3):740-747. doi: 10.1213/01.ane.0000166974.96219.cd.

    PMID: 16115985BACKGROUND

  • Fischer GW, Lin HM, Krol M, Galati MF, Di Luozzo G, Griepp RB, Reich DL. Noninvasive cerebral oxygenation may predict outcome in patients undergoing aortic arch surgery. J Thorac Cardiovasc Surg. 2011 Mar;141(3):815-21. doi: 10.1016/j.jtcvs.2010.05.017. Epub 2010 Jun 25.

    PMID: 20579669BACKGROUND

  • Kazan R, Bracco D, Hemmerling TM. Reduced cerebral oxygen saturation measured by absolute cerebral oximetry during thoracic surgery correlates with postoperative complications. Br J Anaesth. 2009 Dec;103(6):811-6. doi: 10.1093/bja/aep309.

    PMID: 19918024BACKGROUND

MeSH Terms

Conditions

Brain InjuriesBrain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Duane J. Funk, MD

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Duane J. Funk, MD

CONTACT

204 787-1414duane.funk@umanitoba.ca

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 20, 2016

First Posted

June 22, 2016

Study Start

July 1, 2016

Primary Completion

August 1, 2018

Study Completion

December 1, 2019

Last Updated

October 12, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)