CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 146 enrolled
Drug / intervention
Observational studyother
Likely dose
Not stated in record
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Search/NCT01838733
NCT01838733N/ACompleted

Cerebral Oximetry and Perioperative Outcome in Non-Cardiac Surgery

University of Manitoba·observational·Posted Apr 24, 2013·Updated Oct 15, 2024

In Brief

An observational study evaluating Observational study for High Risk Non-cardiac Surgery and 6 related conditions. Completed, enrolled 146 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesCanada

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 24, 2013
Enrollment StartApr 1, 2014
Primary CompletionOct 1, 2018
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 13.2 years ago

Interventions

Observational studyother