Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
754 participants
INTERVENTIONAL
2023-07-08
2025-01-31
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Investigational Device
Measuring 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.
Predicate device
Measuring 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.
Interventions
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Measuring 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.
Eligibility Criteria
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Inclusion Criteria
* 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, 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* Subject, who has an invalid written informed consent or has withdrawn consent.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).
18 Years
ALL
No
Sponsors
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Radiometer Medical ApS
INDUSTRY
Responsible Party
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Principal Investigators
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Lisbet Bærentzen, PhD
Role: STUDY_DIRECTOR
Radiometer Medical ApS
Locations
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UC Davis
Sacramento, California, United States
Countries
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Other Identifiers
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DC-083659
Identifier Type: -
Identifier Source: org_study_id
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