Skip to main content
Clinical Trials/NCT01707446
NCT01707446
Completed
Not Applicable

Role of Cerebral Oximetry In Reducing Delirium After Complex Cardiac Surgery

University Health Network, Toronto1 site in 1 country250 target enrollmentJanuary 2012
ConditionsCardiac Disease

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiac Disease
Sponsor
University Health Network, Toronto
Enrollment
250
Locations
1
Primary Endpoint
Number of patients who suffer from delirium postoperatively
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

Delirium after cardiac surgery is reported in a range of 3-47% of patients. Delirium is a serious complication that results in prolonged length of stay, increased health care costs and is associated with higher death rates. The exact cause involved in the development of delirium after cardiac surgery is unclear. The latest advancement in near-infrared spectroscopy (NIRS) Oximetry offers real-time management of patients at risk of brain injury. This approved device will monitor cerebral oxygenation during and 24hr after cardiac surgery, recording oxygenation in real time allowing the clinical team the opportunity to intervene early to prevent ischemia and possibly preventing untoward events. Adverse events followed include, but are not limited to, stroke, (transient ischemic attacks), heart attack, (myocardial infarction), clots found in lungs (pulmonary embolism), kidney failure, pneumonia, cause of death for 30-days after surgery (all cause mortality).

Hypothesis: Perioperative restoration of rSO2 desaturation to baseline values results in lower delirium rates after complex cardiac surgery.

Registry
clinicaltrials.gov
Start Date
January 2012
End Date
August 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • age \> 60 years
  • combined valve and CABG
  • repeat cardiac surgery
  • multiple valve replacement or repair
  • surgery of ascending aorta and aortic arch
  • signed informed consent.

Exclusion Criteria

  • cardiac surgery without the use of cardiopulmonary bypass
  • symptomatic cerebrovascular disease,
  • history of delirium, or
  • schizophrenia

Outcomes

Primary Outcomes

Number of patients who suffer from delirium postoperatively

Time Frame: Delirium we be assessed postoperatively for 7 days or Discharge

Delirium assessment CAM-ICU preoperatively (baseline) and postoperatively once a day during the first 7 postoperative days or until discharge.

Study Sites (1)

Loading locations...

Similar Trials