Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000539831
Ethics application status
Approved
Date submitted
9/05/2012
Date registered
22/05/2012
Date last updated
10/11/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cerebral Oximetry to Reduce Peri-operative Morbidity: A Pilot Study
Scientific title
The use of cerebral oximetry to reduce the incidence of peri-operative morbidity and mortality in elderly patients undergoing lower limb arthroplasty or bowel resection.
Secondary ID [1] 280463 0
Nil
Universal Trial Number (UTN)
U1111-1130-5874
Trial acronym
CORM Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peri-operative morbidity 286438 0
Condition category
Condition code
Anaesthesiology 286695 286695 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 284825 0
Prevention
Comparator / control treatment
Blinded use of cerebral oximeter (anaesthetist unable to see cerebral oxygen saturation value).
Control group
Placebo

Outcomes
Primary outcome [1] 287093 0
Incidence of any complication in first five days following surgery.

Pre-defined Complications:
Acute myocardial infarction
Cardiac arrest
Re-intubation
Acute pulmonary oedema
Pulmonary embolus
Stroke
Systemic inflammation
Wound infection
Unplanned return to operating room
Acute renal impairment
Unplanned ICU admission
Death
Timepoint [1] 287093 0
5 days
Secondary outcome [1] 297353 0
Incidence of individual specified complications.

Pre-defined Complications:
Acute myocardial infarction
Cardiac arrest
Re-intubation
Acute pulmonary oedema
Pulmonary embolus
Stroke
Systemic inflammation
Wound infection
Unplanned return to operating room
Acute renal impairment
Unplanned ICU admission
Death
Timepoint [1] 297353 0
5 days
Secondary outcome [2] 297354 0
30-day mortality
Timepoint [2] 297354 0
30 days
Secondary outcome [3] 297355 0
Length of hospital stay
Timepoint [3] 297355 0
At discharge
Secondary outcome [4] 297356 0
Incidence of cerebral desaturation (using cerebral oximeter)
Cerebral desaturation is defined as a fall in the cerebral saturation more than 25% below the participant's own baseline. All cerebral saturation data is stored and can be analysed offline.
Timepoint [4] 297356 0
Intra-operative
Secondary outcome [5] 297357 0
Total duration of cerebral saturation < 75% baseline (using cerebral oximeter).
Cerebral desaturation is defined as a fall in the cerebral saturation more than 25% below the participant's own baseline. All cerebral saturation data is stored and can be analysed offline.
Timepoint [5] 297357 0
Intra-operative

Eligibility
Key inclusion criteria
1. Adult patients (age > 70 years)
2. Total knee or hip joint replacement, or bowel resection surgery.
Minimum age
70 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Emergency or unplanned surgery.
2. Inability to provide informed consent for participation.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligible patients will be identified and approached at the pre-admission clinics. If the patient is deemed to be able to give informed consent they will be provided with information about the study as well as the PICF. Patients who choose to participate may be enrolled as an outpatient or on the day of surgery.
Participants are under anaesthesia for the duration of the intervention period and will not be made aware of their assigned group. Allocation is by sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly assigned to one of two groups using a random number allocation system with permuted blocks.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/03/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285221 0
Hospital
Name [1] 285221 0
Austin Health
Country [1] 285221 0
Australia
Funding source category [2] 285222 0
Commercial sector/Industry
Name [2] 285222 0
Covidien
Country [2] 285222 0
United States of America
Primary sponsor type
Hospital
Name
Austin Health
Address
145 Studley Road
Heidelberg VIC 3084
Country
Australia
Secondary sponsor category [1] 284093 0
None
Name [1] 284093 0
Address [1] 284093 0
Country [1] 284093 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287228 0
Austin Health Non-drug Study Advisory Committee
Ethics committee address [1] 287228 0
Research Ethics Unit
Henry Buck Building
145 Studley Road
Austin Hospital,
Heidelberg VIC 3084
Ethics committee country [1] 287228 0
Australia
Date submitted for ethics approval [1] 287228 0
Approval date [1] 287228 0
21/02/2012
Ethics approval number [1] 287228 0
04513

Summary
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.
Trial website
None
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34155 0
Address 34155 0
Country 34155 0
Phone 34155 0
Fax 34155 0
Email 34155 0
Contact person for public queries
Name 17402 0
Dr Dean Cowie
Address 17402 0
Department of Anaesthesia
Austin Health
Studley Rd
Heidelberg VIC 3084
Country 17402 0
Australia
Phone 17402 0
+61 3 94963227
Fax 17402 0
Email 17402 0
[email protected]
Contact person for scientific queries
Name 8330 0
Dr Dean Cowie
Address 8330 0
Department of Anaesthesia
Austin Health
Studley Rd
Heidelberg VIC 3084
Country 8330 0
Australia
Phone 8330 0
+61 3 94963227
Fax 8330 0
Email 8330 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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