Cerebral Oximetry and Perioperative Outcome in Non-Cardiac Surgery
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|ClinicalTrials.gov Identifier: NCT01838733|
Recruitment Status : Recruiting
First Posted : April 24, 2013
Last Update Posted : November 15, 2016
Cerebral desaturations occur frequently in patients undergoing non-cardiac surgery. The definition of what constitutes a cerebral desaturation, the incidence of the phenomenon, the association between desaturations and perioperative outcome, and the mechanistic explanations of cerebral desaturations remain unexamined. This study seeks to identify the true incidence and magnitude of cerebral desaturations in high-risk non-cardiac surgical patients and the association between desaturations and perioperative outcome.
The investigators will attempt to determine the following (1) The proper definition, incidence and severity of decreased cerebral saturation (rSO2) in high-risk non-cardiac surgical patients (2) the mechanisms surrounding decreases in rSO2 by correlating it with alterations in physiologic parameters (such as blood pressure, cardiac output, hemoglobin concentration, and carbon dioxide levels) and (3) to correlate the incidence and severity of decreased rSO2 with relevant perioperative.
The investigators will also analyze a panel of inflammatory biomarkers to determine if these biomarkers have the ability to predict postoperative complications.
The investigators will study 200 high-risk patients undergoing high-risk non-cardiac surgery. The investigators will determine the incidence and severity of decreases in rSO2, the associated factors with the occurrence of decreased rSO2, and the relationship between decreases in rSO2 and adverse perioperative outcome with a composite of well defined perioperative complications such as death, myocardial infarction, cerebrovascular accident, acute kidney injury, delirium, postoperative infections, and the need for mechanical ventilation.
|Condition or disease||Intervention/treatment|
|High Risk Non-cardiac Surgery Death Delirium Kidney Injury Myocardial Infarction Respiratory Failure Postoperative Infection||Other: Observational study|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Cerebral Oximetry and Perioperative Outcome in Non-Cardiac Surgery|
|Study Start Date :||April 2014|
|Estimated Primary Completion Date :||May 2017|
Patients who suffer an intra-operative cerebral desaturation
|Other: Observational study|
- Cerebral desaturation [ Time Frame: Intraoperative ]
- Composite outcome of adverse peri-operative outcome [ Time Frame: 28 days ]Death, myocardial infarction, cerebrovascular accident, acute kidney injury (defined by the AKIN criteria), delirium (as defined by the CAM-ICU method), postoperative infections, and the need for mechanical ventilation >24 hours in the first 28 postoperative days.
- Levels of perioperative inflammatory biomarkers [ Time Frame: 24 Hours ]Levels of a panel of inflammatory biomarkers
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01838733
|Contact: Duane J Funk, MD FRCP(C)||email@example.com|
|Health Sciences Center||Recruiting|
|Winnipeg, Manitoba, Canada, R3A1R9|
|Contact: Duane J Funk, MD FRCP(C) 204-787-1414 firstname.lastname@example.org|
|Principal Investigator: Duane J Funk, MD FRCP(C)|
|Principal Investigator:||Duane J Funk, MD FRCP(C)||University of Manitoba|