Brain Injuries Clinical Trial
Official title:
The Incidence and Magnitude of Cerebral Desaturation in Traumatic Brain Injury (TBI) Patients
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | December 2019 |
Est. primary completion date | August 2018 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Adults 18 years of age or older admitted to ICU with severe TBI (Glasgow coma score <or=8) Exclusion Criteria: |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Canada | University of Manitoba | Winnipeg | Manitoba |
Lead Sponsor | Collaborator |
---|---|
University of Manitoba |
Canada,
Casati A, Fanelli G, Pietropaoli P, Proietti R, Tufano R, Danelli G, Fierro G, De Cosmo G, Servillo G. 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):740-7, table of contents. Erratum in: Anesth Analg. 2006 Jun;102(6):1645. Fierro, Giovanni [corrected to Fierro, Giuseppe]. — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Primary | 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 | No |
Secondary | Association between cerebral desaturation and intracranial pressure | Cerebral desaturation measured by rSO2 output from cerebral oximetry vs intracranial pressure over 72 hours post admission to ICU by an adjusted regression model | 72 hours | No |
Secondary | Association between cerebral desaturation and mean arterial pressure | 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 | 72 hours | No |
Secondary | Association between cerebral desaturation and arterial oxygenation | 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 | 72 hours | No |
Secondary | Association between cerebral desaturation and arterial carbon dioxide concentration | Cerebral desaturation measured by rSO2 output from cerebral oximetry vs arterial CO2 over 72 hours post admission to ICU by an adjusted regression model | 72 hours | No |
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