- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02810145
Cerebral Desaturation in Traumatic Brain Injury
The Incidence and Magnitude of Cerebral Desaturation in Traumatic Brain Injury (TBI) Patients
Study Overview
Status
Conditions
Detailed Description
In patients who have suffered a traumatic brain injury, the current management strategies focus on the maintenance of normotension and normoxia and a normalized intracranial pressure (ICP). Recent evidence calls into question the utility of ICP monitoring in these patients. More advanced cerebral monitoring such as the use of invasive brain tissue oxygen monitors have not found their way into widespread clinical practice. Cerebral oximetry monitoring utilizes the different absorption characteristics of oxygenated and deoxygenated blood to measure global brain oxygen levels.
While clinicians have no ability to reverse the primary brain injury, they can mitigate the secondary injury effects, namely hypoxia and hypotension. It is well known that maintaining normal blood pressure and oxygen saturation can prevent secondary brain injury. However, it is also known that despite the appearance of normal hemodynamics, brain oxygen delivery in the ischemic penumbra may be inadequate. This secondary brain injury is likely related to decreases in cerebral oxygenation (rSO2).
There have been a number of studies that have examined a link between intraoperative decreases in rSO2 and adverse perioperative outcome. These studies suggest that decreases in rSO2 may be related to both adverse neurologic and non-neurologic sequelae. All of these studies suffer from similar flaws, however. They are typically small in size, have varying definitions of what constitutes a cerebral desaturation event, and have incompletely, or poorly defined complications. Also lacking is a mechanistic explanation for the cerebral desaturations as peripheral oxygen saturation typically remains near normal.
The brain can be considered the organ of highest priority when it comes to tissue hypoperfusion during shock states. When oxygen delivery to the brain is decreased below a critical value, cerebral desaturations occur. In the context of TBI, cerebral desaturation may be the hallmark of secondary injury. Consistent with this hypothesis, in the largest cerebral oximetry trial to date, Murkin and colleagues discovered that the incidence and magnitude of cerebral desaturations was related to major non-neurologic organ morbidity.
Two questions arise in relation to this prior research. First, are these cerebral desaturations causative of the adverse outcomes, and second if these desaturations were treated (i.e. if cerebral oxygenation was normalized) would outcome be improved (i.e. or are cerebral desaturations merely an epiphenomenon)?
This study will determine the incidence and severity of cerebral desaturation in traumatic brain injury patients admitted to the Surgical Intensive Care Unit. We will examine factors associated with cerebral desaturation such as ICP and blood pressure, and will determine if decreases in rSO2 are helpful in prognostication of traumatic brain injury.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Duane J. Funk, MD
- Phone Number: 204 787-1414
- Email: duane.funk@umanitoba.ca
Study Locations
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Manitoba
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Winnipeg, Manitoba, Canada, R3T2N2
- Recruiting
- University of Manitoba
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Contact:
- Duane J Funk, MD
- Phone Number: 204-787-1414
- Email: funk@cc.umanitoba.ca
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Contact:
- Duane Funk
- Phone Number: 204-787-1414
- Email: funk@cc.umanitoba.ca
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Principal Investigator:
- Duane J Funk, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adults 18 years of age or older admitted to ICU with severe TBI (Glasgow coma score <or=8)
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of cerebral desaturation
Time Frame: 72 hours
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The frequency of cerebral desaturation from time of admission to 72 hours post admission to ICU as measured by rSO2 output from cerebral oximetry.
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72 hours
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Magnitude of cerebral desaturation
Time Frame: 72 hours
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The magnitude of cerebral desaturation from time of admission to 72 hours post admission to ICU as measured by rSO2 output from cerebral oximetry.
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72 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Association between cerebral desaturation and intracranial pressure
Time Frame: 72 hours
|
Cerebral desaturation measured by rSO2 output from cerebral oximetry vs intracranial pressure over 72 hours post admission to ICU by an adjusted regression model
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72 hours
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Association between cerebral desaturation and mean arterial pressure
Time Frame: 72 hours
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Cerebral desaturation measured by rSO2 output from cerebral oximetry vs mean arterial pressure over 72 hours post admission to ICU by an adjusted regression model
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72 hours
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Association between cerebral desaturation and arterial oxygenation
Time Frame: 72 hours
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Cerebral desaturation measured by rSO2 output from cerebral oximetry vs arterial oxygen tension over 72 hours post admission to ICU by an adjusted regression model
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72 hours
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Association between cerebral desaturation and arterial carbon dioxide concentration
Time Frame: 72 hours
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Cerebral desaturation measured by rSO2 output from cerebral oximetry vs arterial CO2 over 72 hours post admission to ICU by an adjusted regression model
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72 hours
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Duane J. Funk, MD, University of Manitoba
Publications and helpful links
General Publications
- 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.
- 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.
- 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. Erratum In: Anesth Analg. 2006 Jun;102(6):1645. Fierro, Giovanni [corrected to Fierro, Giuseppe].
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HS19659
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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