ABL90 FLEX PLUS Ki MC BASE Parameters
ConditionDiagnostic Tests
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRadiometer Medical ApS
About this trial
The purpose is a Method Comparison Study on ABL90 FLEX PLUS for BASE Parameters in Whole Blood Samples.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
The subject must be 18 years or older.
Informed consent obtained from subject able to understand information given and willing and able to voluntary give their consent to participate. Where the subject cannot provide informed consent, informed consent is obtained from the legally authorized/designated representative, once they have been fully informed.
For arterial and venous blood draw, the subject must have existing arterial and/or venous lines or undergo venipuncture as part of standard of care (criteria not appliable to apparently healthy individuals donating blood via venipuncture).
Disqualifiers
Subjects who have previously provided successful measurements of arterial or venous samples for this study.
Subjects for whom the investigator (or designee) evaluates that sample collection would pose an unnecessary or unacceptable safety risk.
Trial population
Adult in- and out-patients under standard of care to cover the reportable range of the parameters. Apparently healthy individuals may also provide samples through volunteer venipuncture to cover normal levels and for contriving.
Trial design
Design model
Case-only
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Analytical Performance of ABL90 FLEX PLUS Ki.
Analytical performance of the ABL90 FLEX PLUS Ki for pH, pCO₂, pO₂, cNa⁺, cK⁺, cCa²⁺, cCl-, cGlu, and cLac. Analytical performance will be assessed by: * agreement with the comparator method, evaluated by bias and corresponding 95% confidence intervals at predefined medical decision levels using regression analyses; and * repeatability, evaluated as standard deviation (SD) or coefficient of variation (CV), as applicable, with corresponding 95% confidence intervals. Analyses will be performed separately for arterial and venous blood samples using data combined across study site.
Time frame
6-8 monthSecondary outcomes
1
Additional Characterization of Analytical Performance of ABL90 FLEX PLUS Ki.
Additional characterization of analytical performance through site-specific analyses of bias and repeatability, and evaluation of the relationship between the ABL90 FLEX PLUS Ki and the comparator method using regression slope, corresponding 95% confidence intervals, and coefficient of determination (R²).
Time frame
6-8 month.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: