Role of Cerebral Oximetry In Reducing Delirium After Complex Cardiac Surgery
This trial is active, not recruiting.
|Treatments||cerebral oximetry monitor (the invos® cerebral/somatic oximeter), an alarm threshold at 75% of the baseline rso2 value|
|Sponsor||University Health Network, Toronto|
|Start date||January 2012|
|End date||December 2014|
|Trial size||250 participants|
|Trial identifier||NCT01707446, 11-0650-A|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Number of patients who suffer from delirium postoperatively
time frame: Delirium we be assessed postoperatively for 7 days or Discharge
Male or female participants at least 60 years old.
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
|Official title||Role of Cerebral Oximetry In Reducing Delirium After Complex Cardiac Surgery|
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