None listed
Conditions
Brief summary
Cerebral oximetry is a clinical monitor which is used routinely for heart surgery patients at Austin Health. When the device is used, a sensor is applied to the forehead and safe near-infrared light is shone through the skull. The reflected light gives information about the level of oxygen in the brain. Previous research has shown that using this monitor can reduce the risk of complications after heart surgery. Other clinical research has shown that complications after surgery are more common as people get older. In one large study it was shown that complications occur in one fifth of patients over the age of 70. The complications studied included heart attack, major breathing complications, stroke, infections, kidney failure, being admitted to the intensive care unit, or death. The aim of this study is to find out whether using a cerebral oximeter during other types of surgery can reduce the rate of complications for patients over the age of 70. There is currently no research evidence to show whether this is the case. 40 patients over the age of 70 will be asked to participate in this study. These patients will all be having joint replacement or bowel surgery. All the participants will have a cerebral oximeter monitor applied at the start of the anaesthetic. For half the participants the anaesthetist will no be able to see the numbers on the monitor. In the other half, the anaesthetist will be asked to monitor the levels of oxygen in the brain, and to try to keep them close to (within 25% of) the participant’s starting level. This is done by methods which are part of normal anaesthetic care. For example, the anaesthetist makes small changes to the amount of anaesthetic, or to the blood pressure. There is no other change to the operation, anaesthetic, or hospital care. The number and types of complications which occur in each of these two groups will be compared. This study will determine if using the cerebral oximeter results in fewer complications. The results of this small study may help to design larger research studies in the future.
Interventions
Intra-operative cerebral oximetry.
Cerebral oximetry is a non-invasive method for measuring the oxygenation of brain tissue. It is based on the principle of near-infrared reflactance spectroscopy (NIRS), and works in a similar way to the pulse oximeter.
The anaesthetist will be given instructions on how to apply the cerebral oximeter to the participant’s forehead, and how to turn on the monitor and store a baseline cerebral saturation value. They will then open the envelope which will contain
Intra-operative cerebral oximetry. Cerebral oximetry is a non-invasive method for measuring the oxygenation of brain tissue. It is based on the principle of near-infrared reflactance spectroscopy (NIRS), and works in a similar way to the pulse oximeter. The anaesthetist will be given instructions on how to apply the cerebral oximeter to the participant’s forehead, and how to turn on the monitor and store a baseline cerebral saturation value. They will then open the envelope which will contain the randomisation allocation. If the participant is in the control group (group C) the monitor will be covered throughout the case, and turned off prior to leaving the operating theatre. If the participant is allocated to the intervention group (group I), the anaesthetist will monitor the cerebral saturation throughout the operation. They will be instructed to aim to keep the cerebral saturation within 25% of the patient’s baseline value. The anaesthetist will be provided with a list of suggested methods to improve cerebral saturation e.g. management of blood pressure, oxygenation or carbon dioxide tension. The use of these interventions, as well as the choice and timing of interventions will be entirely the choice of the anaesthetist. All suggested interventions are part of routine anaesthetic management. At the conclusion of the operation the monitor will be turned off prior to leaving the operating theatre.
Sponsors
Austin Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult patients (age > 70 years) 2. Total knee or hip joint replacement, or bowel resection surgery.
Exclusion criteria
1. Emergency or unplanned surgery. 2. Inability to provide informed consent for participation.
Outcome results
None listed