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Cerebral Oximetry and Perioperative Outcome in Non-Cardiac Surgery

NCT01838733 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 146

Last updated 2024-10-15

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Observational study

Sponsors & Collaborators

  • Canadian Anesthesia Research Foundation

    collaborator UNKNOWN

  • University of Manitoba

    lead OTHER

Principal Investigators

  • Duane J Funk, MD FRCP(C) · University of Manitoba

Eligibility

Min Age
65 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2018-10-31
Completion
2018-10-31

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01838733 on ClinicalTrials.gov