None listed
Conditions
Brief summary
Cardiac surgery is a very common procedure for the treatment of coronary artery disease, however it is not without side effects. Some of these complications, such as stroke, are overtly debilitating, whilst others such as mood changes are less obvious, but still affect daily activities. The aetiology of these complications remains unclear. We believe that they arise from many different causes, some of which relate to the cardiopulmonary bypass machine that is used to support patients during heart surgery. We propose to investigate a device that will help us determine if the brain is being correctly protected during heart surgery using cardiopulmonary bypass. We plan to utilise this device to continuously monitor the amount of oxygen that is supplied to the brain during heart surgery. In addition, we will combine monitoring of the brain with therapeutic strategies designed to limit the exposure of the brain to potentially harmful events. Ultimately this information could be used to reduce the incidence of postoperative brain complications.
Interventions
4 groups, with blinded or unblinded operator with respect to cerebral oximetry monitor and unblinded operator with respect to rewarming rate. Group 1: Standard rewarming with blinded near infrared spectroscopy (control)
Group 2: Standard rewarming with interventional near infrared spectroscopy
Group 3: Slow rewarming with blinded near infrared spectroscopy
Group 4: Slow rewarming with interventional near infrared spectroscopy
Cerebral monitoring occurs from time immediately prior to intubation
4 groups, with blinded or unblinded operator with respect to cerebral oximetry monitor and unblinded operator with respect to rewarming rate. Group 1: Standard rewarming with blinded near infrared spectroscopy (control) Group 2: Standard rewarming with interventional near infrared spectroscopy Group 3: Slow rewarming with blinded near infrared spectroscopy Group 4: Slow rewarming with interventional near infrared spectroscopy Cerebral monitoring occurs from time immediately prior to intubation to the time the patient is extubated (12-15 hr). Standard rewarming is when the patient is rewarmed at a maximum rate of 1 degree per minute, slow rewarming is when the patient is rewwarmed at a maximum rate 0.5C per minute. INVOS Cerebral Oximeter interventions include increasing flow, gas sweep rates, cardiac output, oxygen saturation and hematocrit. Blinded near infrared spectroscopy is when the perfusionist is unaware of what the spectrocopy results are during the oepration (equivalent to current practice), interventional is when the perfusionist uses the interventiones noted above to manage the perfusion based upon the near infra red spctrcopy results. The device is called teh INVOS cerebral oximeter, details are avaialble on the follwoing website http://www.somanetics.com/invos.htm. INVOS means "In-Vivo Optical Spectroscopy".
Sponsors
Flinders Medical Centre
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The patient sample: will consist of participants of both gender, requiring elective isolated coronary artery bypass graft surgery at Flinders Medical Centre; The patient is willing to participate and has signed a consent form.
Exclusion criteria
English not first language; Previous cerebrovascular disease including CVA, RIND, or TIA anytime prior to planned surgery; Emergency and urgent coronary artery surgery Previous open heart surgery History of neurological disease/insult
Outcome results
None listed