ABL90 Flex Plus Method Comparison Study_Adults

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis
Dates
study started
completion around

Description

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.

Official Title

ABL90 FLEX PLUS 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.

Details

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).

Keywords

Diagnostic Test, Blood gas, Measuring of analytes, Investigational Device, Predicate device

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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  • Subject, who has an invalid written informed consent or has withdrawn consent.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).

Location

  • UC Davis accepting new patients
    Sacramento California 95817 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Radiometer Medical ApS
ID
NCT06078956
Study Type
Interventional
Participants
Expecting 360 study participants
Last Updated