Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000769088
Ethics application status
Not yet submitted
Date submitted
8/09/2010
Date registered
15/09/2010
Date last updated
15/09/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Accuracy of Masimo Pulse Co-oximeters for Haemoglobin Measurement
Scientific title
Comparison of Haemoglobin as measured by Masimo Radical-7 Pulse Co-Oximeter and Arterial Blood Gas in patients in the operating theatre who would otherwise have had an arterial blood gas.
Secondary ID [1] 252660 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Accuracy of Haemoglobin Measurements with Different Devices 258155 0
Condition category
Condition code
Anaesthesiology 258333 258333 0 0
Anaesthetics

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients having an arterial blood gas (ABG) will also have pulse co-oximeter probe placed for measurement.
ABG involves aspiration of blood from an arterial line into an ABG syringe which is then analysed by a machine which is able to measure haemoglobin concentration. ABGs are routinely performed on patients in theatre. Additional ABGs will not be performed because of this study. The process from blood sampling to result is abuot 5 minutes. They are normally performed up to every few minutes to not at all on patients with arterial cannulau in theatre as dictated by clinical circumstances.
The pulse co-oximeter probe will be placed on the patient's finger about a minute prior to ABG sampling (as 45 seconds is required for measurement. The pulse co-oximeter passes multiple wavelengths of light through tissue (similar to current pulse oximeters) and a computer is able to calculate haemoglobin concentration from this.
Data to be collected over 2 weeks.
Intervention code [1] 257173 0
Not applicable
Comparator / control treatment
none
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259187 0
difference in haemoglobin on pulse co-oximeter and ABG
Timepoint [1] 259187 0
both values available within minutes of taking measurements
Secondary outcome [1] 265542 0
if sufficient numbers for statistical analysis, accuracy of pulse co-oximeter to measure trend in haemoglobin will be analysed. This will require the same data collected as for the primary outcome.
Timepoint [1] 265542 0
same as for primary outcome - all values available within minutes of taking measurement

Eligibility
Key inclusion criteria
All patients presenting to the operating theatre who are to have a blood gas.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Emergent situations where use of the pulse co-oximeter may delay vital treatment

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/09/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 2859 0
New Zealand
State/province [1] 2859 0
Waikato

Funding & Sponsors
Funding source category [1] 257624 0
Self funded/Unfunded
Name [1] 257624 0
Country [1] 257624 0
New Zealand
Primary sponsor type
Individual
Name
Brendon MANIKKAM
Address
C/- Waikato Hospital
Pembroke Street
Hamilton
3206
Country
New Zealand
Secondary sponsor category [1] 256845 0
None
Name [1] 256845 0
Address [1] 256845 0
Country [1] 256845 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 259642 0
New Zealand Health and Disability Ethics Committees
Ethics committee address [1] 259642 0
Ministry of Health
133 Molesworth St
PO Box 5013
Wellington
6011
Ethics committee country [1] 259642 0
New Zealand
Date submitted for ethics approval [1] 259642 0
04/09/2010
Approval date [1] 259642 0
Ethics approval number [1] 259642 0

Summary
Brief summary
Masimo manufactures a pulse co-oximeter which can measure haemoglobin and which looks similar to a pulse oximeter. This study compares the haemoglobin values obtained with the device and ABG in patients in the operating theatre.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31624 0
Address 31624 0
Country 31624 0
Phone 31624 0
Fax 31624 0
Email 31624 0
Contact person for public queries
Name 14871 0
Brendon MANIKKAM
Address 14871 0
C/- Waikato Hospital
Pembroke Street
Hamilton
3206
Country 14871 0
New Zealand
Phone 14871 0
64 27 6932069
Fax 14871 0
Email 14871 0
bman015@gmail.com
Contact person for scientific queries
Name 5799 0
Brendon MANIKKAM
Address 5799 0
C/- Waikato Hospital
Pembroke Street
Hamilton
3206
Country 5799 0
New Zealand
Phone 5799 0
64 27 6932069
Fax 5799 0
Email 5799 0
bman015@gmail.com

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
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