Diagnostic Test
Conditions
Keywords
Blood gas
Brief summary
The goal of this clinical trial is to validate performance claims for method comparison for the ABL90 FLEX PLUS for pH, pCO2, pO2, cCa2+, cCl-, cK+, cNa+, cGlu, cLac, ctHb, sO2, FO2Hb, FMetHb, FCOHb and FHHb in heparinized whole blood in a Point of Care (POC) setting.
Detailed description
The main question it aims to answer is: To quantify the relationship using comparison measurement from the same sample between ABL90 FLEX PLUS and the predicate device within the reportable range for all 15 parameters in heparinized arterial and venous patient whole blood in syringe measuring mode (S65, SP65) and heparinized capillary whole blood samples in capillary measuring mode (C65).
Interventions
DEVICEMeasuring of analytes
Method Comparison Study for pH, pCO2, pO2, cCa2+, cCl-, cK+, cNa+, cGlu, cLac, ctHb, sO2, FO2Hb, FMetHb, FCOHb and FHHb in whole blood in adult population.
Sponsors
Radiometer Medical ApS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The subject must be 18 years or older. * Informed consent collected from subject or from relative(s) able to understand information given and willing and able to voluntary give their consent to participate in this study. * The subject will provide blood samples from the existing Aand/ or V-lines, and/or from a finger stick. * Subject evaluated as suitable according to the protocol to enroll in the study by principal investigator or designee.
Exclusion criteria
* Subject where sample collection is evaluated by principal investigator or designee to impose an unnecessary risk. * Subject, who is pregnant or breastfeeding. * Subject, who has an invalid written informed consent or has withdrawn consent. * Subject who has already provided successful measurements of arterial, venous and capillary samples, to cover both syringe modes and the capillary mode * Subjects taking medications listed in Appendix 1 with last dose within 72 hours, should be excluded due to interference. * Subjects with known infectious disease such as Hepatitis C and HIV (in order to ensure the operator safety).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Slope, R^2 and bias at medical decision points | 6-9 months | Primary Endpoints: Slope, R\^2 and bias at medical decision points for each combination of modes and sample type, across sites |
Countries
United States
Outcome results
None listed