Cerebral Oximetry and Perioperative Outcome in Non-Cardiac Surgery

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 by University of Manitoba
Sponsor:
Collaborator:
Canadian Anesthesia Research Foundation
Information provided by (Responsible Party):
Dr. Duane Funk, University of Manitoba
ClinicalTrials.gov Identifier:
NCT01838733
First received: April 20, 2013
Last updated: April 9, 2014
Last verified: April 2014
  Purpose

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.

We 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.

We will study 200 high-risk patients undergoing high-risk non-cardiac surgery. We 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 Intervention
High Risk Non-cardiac Surgery
Death
Delirium
Kidney Injury
Myocardial Infarction
Respiratory Failure
Postoperative Infection
Other: Observational study

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cerebral Oximetry and Perioperative Outcome in Non-Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Cerebral desaturation [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Composite outcome of adverse peri-operative outcome [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 200
Study Start Date: April 2014
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cerebral Desaturation
Patients who suffer an intra-operative cerebral desaturation
Other: Observational study

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   65 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Age >65 High-risk non-cardiac surgery (aortic aneurysm repair, hepatic resection, pancreatectomy, colon resection)

Criteria

Inclusion Criteria:

  • Age >65
  • High risk surgery (aortic aneurysm repair, hepatic resection, pancreatectomy, colon resection)

Exclusion Criteria:

  • Previous stroke
  • Dementia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01838733

Contacts
Contact: Duane J Funk, MD FRCP(C) 204-787-1414 funk@cc.umanitoba.ca

Locations
Canada, Manitoba
Health Sciences Center Not yet recruiting
Winnipeg, Manitoba, Canada, R3A1R9
Contact: Duane J Funk, MD FRCP(C)    204-787-1414    funk@cc.umanitoba.ca   
Principal Investigator: Duane J Funk, MD FRCP(C)         
Sponsors and Collaborators
University of Manitoba
Canadian Anesthesia Research Foundation
Investigators
Principal Investigator: Duane J Funk, MD FRCP(C) University of Manitoba
  More Information

Publications:

Responsible Party: Dr. Duane Funk, Assistant Professor, University of Manitoba
ClinicalTrials.gov Identifier: NCT01838733     History of Changes
Other Study ID Numbers: B2013:015
Study First Received: April 20, 2013
Last Updated: April 9, 2014
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Delirium
Infarction
Myocardial Infarction
Respiratory Insufficiency
Wounds and Injuries
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 24, 2014