ANZCTR - Registration

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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]

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

Condition category

Condition code

Anaesthesiology

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]

Prevention

Comparator / control treatment

Blinded use of cerebral oximeter (anaesthetist unable to see cerebral oxygen saturation value).

Control group

Placebo

Outcomes

Primary outcome [1]

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]

5 days

Secondary outcome [1]

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]

5 days

Secondary outcome [2]

30-day mortality

Timepoint [2]

30 days

Secondary outcome [3]

Length of hospital stay

Timepoint [3]

At discharge

Secondary outcome [4]

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]

Intra-operative

Secondary outcome [5]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Austin Health

Address [1]

Department of Anaesthesia
Austin Health
Studley Rd
Heidelberg VIC 3084

Country [1]

Australia

Funding source category [2]

Commercial sector/Industry

Name [2]

Covidien

Address [2]

Covidien
6135 Gunbarrel Ave
Boulder, CO 80301
USA

Country [2]

United States of America

Primary sponsor type

Hospital

Name

Austin Health

Address

145 Studley Road
Heidelberg VIC 3084

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Austin Health Non-drug Study Advisory Committee

Ethics committee address [1]

Research Ethics Unit
Henry Buck Building
145 Studley Road
Austin Hospital, 
Heidelberg VIC 3084

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

21/02/2012

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Dean Cowie

Address

Department of Anaesthesia
Austin Health
Studley Rd
Heidelberg VIC 3084

Country

Australia

Phone

+61 3 94963227

Fax

dean.cowie@austin.org.au

Contact person for scientific queries

Name

Dr Dean Cowie

Address

Department of Anaesthesia
Austin Health
Studley Rd
Heidelberg VIC 3084

Country

Australia

Phone

+61 3 94963227

Fax

dean.cowie@austin.org.au

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

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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