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Trial registered on ANZCTR


Registration number
ACTRN12606000131550
Ethics application status
Approved
Date submitted
10/04/2006
Date registered
11/04/2006
Date last updated
11/04/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of the accuracy of pulse oximeters compared with CO-Oximetry in hypoxaemic normal subjects.
Scientific title
Evaluation of the accuracy of pulse oximeters compared with CO-Oximetry in hypoxaemic normal subjects.
Universal Trial Number (UTN)
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypoxaemia 1098 0
Condition category
Condition code
Blood 1178 1178 0 0
Other blood disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Subjects are acutely exposed to a range of hypoxic gas mixtures to induce falls in arterial oxygen saturation in the range 95-70%. Oximeter readings (SpO2) are compared with simultaneously determined CO-oximetry measurements of SaO2 from arterial blood samples. These samples are drawn once a steady state has been achieved at each level of hypoxaemia, usually 3-5 minutes.
Intervention code [1] 976 0
Other interventions
Comparator / control treatment
No comparator.
Control group

Outcomes
Primary outcome [1] 1589 0
Accuracy of SpO2 compared with SaO2
Timepoint [1] 1589 0
Arterial blood samples are drawn once a steady state has been achieved at each level of hypoxaemia, usually 3-5 minutes.
Secondary outcome [1] 2882 0
Response characteristics of the oximeters are assessed during the initial period following step changes in inspired oxygen concentration.
Timepoint [1] 2882 0
The period is varied but it is usually within 2-3 minutes.

Eligibility
Key inclusion criteria
Adults
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cardiac or respiratory disease. History of CVA.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
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] 1289 0
Commercial sector/Industry
Name [1] 1289 0
Compumedics Ltd
Address [1] 1289 0
Country [1] 1289 0
Primary sponsor type
Other
Name
Institute for Breathing and Sleep
Address
Country
Australia
Secondary sponsor category [1] 1139 0
None
Name [1] 1139 0
Nil
Address [1] 1139 0
Country [1] 1139 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2621 0
Austin Hospital
Ethics committee address [1] 2621 0
Ethics committee country [1] 2621 0
Australia
Date submitted for ethics approval [1] 2621 0
Approval date [1] 2621 0
Ethics approval number [1] 2621 0
02240

Summary
Brief summary
Pulse oximeters are used in many areas of clinical medicine and a clear understanding of their performance is critical to appropriate and safe use. This study aims to evaluate the accuracy of a new pulse oximeter under a range of oxygen conditions compared with CO-ocimetry, which is the current reference method for this measurement.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36151 0
Address 36151 0
Country 36151 0
Phone 36151 0
Fax 36151 0
Email 36151 0
Contact person for public queries
Name 10165 0
Peter Rochford
Address 10165 0
Department of Respiratory and Sleep Medicine
Austin Hospital
Studley Rd
Heidelberg VIC 3081
Country 10165 0
Australia
Phone 10165 0
+61 3 94963673
Fax 10165 0
Email 10165 0
peter.rochford@austin.org.au
Contact person for scientific queries
Name 1093 0
Peter Rochford
Address 1093 0
Department of Respiratory and Sleep Medicine
Austin Hospital
Studley Rd
Heidelberg VIC 3081
Country 1093 0
Australia
Phone 1093 0
+61 3 94963673
Fax 1093 0
Email 1093 0
peter.rochford@austin.org.au

No information has been provided regarding IPD availability
Summary results
No Results