Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000650291
Ethics application status
Not yet submitted
Date submitted
25/03/2009
Date registered
31/07/2009
Date last updated
31/07/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Accuracy of a non-invasive monitor of oxygen delivery in patients undergoing cardiac surgery
Scientific title
Accuracy of a non-invasive monitor of heart function and oxygen delivery during cardiac surgery
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
critical illness
cardiac surgery 4526 0
Condition category
Condition code
Cardiovascular 4814 4814 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Monitoring heart function is routinely undertaken during cardiac surgery by inserting a plastic tube (pulmonary artery catheter) into a blood vessel into the neck and then advancing the plastic tube into the heart This technique can on occasion injury the heart or lungs. We have developed a novel monitor that may provide the same monitoring of heart function but without the need to insert a plastic tube into the heart (non-invasive) and therefore remove the risk or injury to the heart and lungs. We would like to assess the accuracy of this new non invasive monitor in comparison to the routine invasive method. The technique uses two distinct wavelengths of light in the infra-red range. The study will be undertaken in patients undergoing cardiac surgery. In addition to the routine invasive monitoring you will also receive non-invasive monitoring of heart function. A sensor will be placed on the skin over the heart. The sensor emits light into the heart and this provides a signal that assesses the adequacy of heart function. An ultrasound machine will be used to optimally position the sensor over the heart (these are the machines used in pregnant women to gain images of the baby). The monitoring of the heart function will continue until the patient is stable and discharged from the Intensive Care Unit. The results of the non-invasive monitor will be compared with those obtained using the routine invasive method. All patients will have invasive and non invasive monitoring. The accuracy of the non-invasive method will be compared with the invasive pulmonary artery catheter in each patient.
Intervention code [1] 4285 0
Early detection / Screening
Comparator / control treatment
All patients will have monitoring with both a pulmonary artery catheter and with the non -invasive system.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5673 0
Extent of agreement between the invasive and non-invasive methods of assessing venous oxygen saturation. Invasive method is a blood test , non invasive method uses infra red light shone on the skin.
Timepoint [1] 5673 0
routine invasive monitoring in patients following cardiac surgery until the patient is stable and discharged from the Intensive Care Unit.
Secondary outcome [1] 257033 0
nil
Timepoint [1] 257033 0
nil

Eligibility
Key inclusion criteria
booked to have cardiac surgery
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
pulmonary artery catheter not planned to be inserted as part of routine management

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
all patients get invasive and non -invasive monitoring - there is no allocation therefore
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4714 0
Government body
Name [1] 4714 0
Commonwealth emerging technology grant
Country [1] 4714 0
Australia
Primary sponsor type
Hospital
Name
St Vincents Hospital
Address
41 Victoria Pde Fitzroy 3065 Vic
Country
Australia
Secondary sponsor category [1] 4260 0
Government body
Name [1] 4260 0
Aus Industry
Address [1] 4260 0
Aus Industry Canberra ACT

10 Binara St Canberra 2601
Country [1] 4260 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 6749 0
Ethics committee address [1] 6749 0
Ethics committee country [1] 6749 0
Date submitted for ethics approval [1] 6749 0
26/03/2009
Approval date [1] 6749 0
Ethics approval number [1] 6749 0

Summary
Brief summary
We have developed a unique non-invasive method to monitor oxygen levels of blood in large veins of the body and also the right side of the heart. Successful completion of this development will reduce serious complications in critically ill patients and generate cost savings for hospitals and the community by allowing valuable resources to be used more productively. This clinical trial will compare this novel device with the existing invasive technology.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29434 0
Address 29434 0
Country 29434 0
Phone 29434 0
Fax 29434 0
Email 29434 0
Contact person for public queries
Name 12681 0
Barry Dixon
Address 12681 0
Intensive Care Unit, St Vincents Hospital 41 Victoria Pde, Fitzroy 3065, Victoria
Country 12681 0
Australia
Phone 12681 0
61 3 92884488
Fax 12681 0
Email 12681 0
barry.dixon@svhm.org.au
Contact person for scientific queries
Name 3609 0
Barry Dixon
Address 3609 0
Intensive Care Unit, St Vincents Hospital 41 Victoria Pde, Fitzroy 3065, Victoria
Country 3609 0
Australia
Phone 3609 0
61 3 92884488
Fax 3609 0
Email 3609 0
barry.dixon@svhm.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.