Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000370404
Ethics application status
Approved
Date submitted
15/02/2007
Date registered
13/07/2007
Date last updated
13/07/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Blood gas monitoring in Cardiac Surgery
Scientific title
Improving Cardiac Surgery: Does Continuous blood gas monitoring with the CDI-500 have a role to play?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiopulmonary bypass blood gas monitoring. 1950 0
Condition category
Condition code
Cardiovascular 2045 2045 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group 2: Cardiopulmonary bypass blood gas management will be conducted utilising a CDI 500, the current blood gas management protocol, however the CDI 500 will be used real time to influence perfusion management (intervention).

The control group (group 1) is current the current managment with the addition of the monitoring device (CDI 500) in the circuit. The output of the device is not accessible during the case.
Intervention code [1] 1603 0
Treatment: Devices
Comparator / control treatment
Group 1: Cardiopulmonary bypass blood gas management will be conducted, following the current blood gas management protocol, with blood gas results generated from the radiometer blood gas machine in the ICU utilised to guide current practice (control).
Control group
Active

Outcomes
Primary outcome [1] 2874 0
Improved blood gas management during cardiopulmonary bypas
Timepoint [1] 2874 0
Monitored throughout the time period of bypass.
Secondary outcome [1] 4842 0
Routine clinical outcomes
Timepoint [1] 4842 0
Measured in the post oeprative period, prior to discharge.

Eligibility
Key inclusion criteria
All patients undergoing cardiac surgery (either coronary artery bypass graft or valve replacement/repair or combine graft and valve surgery) requiring cardiopulmonary bypassElective procedureThe patient is willing to participate and has signed a consent form
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
English not first language;Off pump surgery converted to cardiopulmonary bypassEmergency cardiac surgical procedures requiring cardiopulmonary bypass

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)
sealed opaque envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (i.e., computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Surgeon, data analyst, clinical data collector will be blinded.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/02/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2188 0
Commercial sector/Industry
Name [1] 2188 0
Terumo Australasia
Country [1] 2188 0
Primary sponsor type
Other Collaborative groups
Name
Ashford Community Healthcare Alliance
Address
Country
Australia
Secondary sponsor category [1] 1974 0
None
Name [1] 1974 0
None
Address [1] 1974 0
Country [1] 1974 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3985 0
Ashford Community Hospital-BELLBERRY HUMAN RESEARCH ETHICS COMMITTEE
Ethics committee address [1] 3985 0
Ethics committee country [1] 3985 0
Australia
Date submitted for ethics approval [1] 3985 0
Approval date [1] 3985 0
Ethics approval number [1] 3985 0

Summary
Brief summary
Cardiopulmonary bypass is a procedure used for cardiac surgery. Currently during bypass we need to monitor blood gases to make sure we are oxygenating your blood. This monitoring, currently involves taking samples from the heart lung machine and sending them off for results.
We plan to assess a new device, that we can place on the heart lung machine, that will allow us to get blood gas results immediately and so we can act upon these straight away.

The aim of this study is to assess the ability of the CDI 500 blood gas monitor to detect blood gas parameters during your surgery. In addition, this study will assess the impact on outcomes of the use of this monitor.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27537 0
Address 27537 0
Country 27537 0
Phone 27537 0
Fax 27537 0
Email 27537 0
Contact person for public queries
Name 10792 0
Robert A Baker
Address 10792 0
Flinders Medical Centre
Country 10792 0
Australia
Phone 10792 0
61884042015
Fax 10792 0
Email 10792 0
[email protected]
Contact person for scientific queries
Name 1720 0
Robert A Baker
Address 1720 0
Flinders Medical Centre
Country 1720 0
Australia
Phone 1720 0
61884042015
Fax 1720 0
Email 1720 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.