RecruitingACTRN12607000436471

Cerebral Oximetry in Cardiac Surgery

Using Cerebral oximetry (INVOS 5100) during cardiopulmonary bypass in patients requiring elective isolated coronary artery bypass graft surgery to improve neuropsychological outcomes or composite clincal outcomes (composite endpoint based on the presence of 30-day mortality or a major morbidity (permanent stroke, renal dysfunction or failure, cardiac surgery reoperation, prolonged ventilation, deep sternal wound infection)).

Sponsor

Flinders Medical Centre

Enrollment

300 participants

Start Date

Apr 3, 2003

Study Type

Interventional

Conditions

Patients cerebral oxygenation during cardiopulmonary bypass

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.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is looking at a brain oxygen monitoring technique during heart bypass surgery. When patients have heart surgery using a heart-lung machine, there is a risk that the brain does not get enough oxygen — which can lead to stroke, mood changes, or memory problems after surgery. This study uses a device called a cerebral oximeter, worn on the forehead, to continuously measure the oxygen level in the brain during surgery. Researchers will combine this monitoring with steps designed to protect the brain, to see if this reduces brain complications after surgery. You may be eligible if: - You are 18 years of age or older - You are scheduled for elective (non-emergency) coronary artery bypass graft (CABG) surgery at Flinders Medical Centre - You are willing to participate and have signed the consent form You may NOT be eligible if: - English is not your first language - You have previously had a stroke, mini-stroke, or TIA (transient ischaemic attack) - You require emergency or urgent heart surgery - You have previously had open heart surgery - You have a history of a neurological disease or brain injury Talk to your doctor about whether this trial might be right for you.

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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 sp

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".

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ACTRN12607000436471