24024 - Clinical In-use Analyte Stability Study for 17 Parameters in Venous and Arterial Blood for PICO A and safePICO A
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Radiometer Medical ApS
- Enrollment
- 43
- Locations
- 3
- Primary Endpoint
- In-use analyte stability in adult arterial and venous whole blood in PICO A and safePICO A for each parameter, measuring at five testing timepoints measured in minutes (t=0, t=10, t=20, t=30, t=45).
Study Overview
Brief Summary
The purpose is to determine the in-use stability of 17 parameters (pH, pCO2, pO2, cNa+, cCa2+, cCl-, cK+, cGlu, cLac, ctHb, sO2, FMetHb, FCOHb, FO2Hb, FHHb, FHbF & ctBil) in adult arterial and venous whole blood drawn and stored in aspirating syringes (PICO A and safePICO A) measured on ABL90 FLEX PLUS analyzer.
The study aims to determine the in-use sample stability for up to 45 min at room temperature (18-25 °C) for arterial and venous blood sample analysis in the PICO A and safePICO A syringes for all 17 parameters.
Detailed Description
In-use analyte stability study for 17 parameters. The stability study is a 5 time-point study analyzing five (5) syringes at T = 0 min, 10 min, 20 min, 30 min and 45 min. after sample collection. Series of five (5) syringes are collected from each investigational device safePICO A and PICO A. Each type of syringe will be analyzed on one ABL90 Flex Plus analyzer and for both types of blood (Arterial or Venous). For each syringe type a minimum of 50 + 7 series (7 contrived series) with samples within the reportable ranges will need to be tested for each blood type.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjects must meet all the criteria listed below to be eligible for participation in the study.
- •Subject must be 18 years of age or older.
- •Subject must have an arterial and/or venous line established as a part of the standard of care.
- •Subject evaluated by the principal investigator or designee as suitable for the study according to the protocol.
Exclusion Criteria
- •Subjects meeting any of the criteria listed below will not be eligible for participation in the study.
- •Subjects, who are pregnant or breastfeeding.
- •Subjects who have been previously enrolled into this study.
- •Subjects exposed to following substances within the last 72 hours:
- •Acetylsalicylic Acid Sodium Salt at dose equal or above 1 gram/day
- •Acetylcysteine
- •Fluorescein dye
- •Patent Blue dye
Outcomes
Primary Outcomes
In-use analyte stability in adult arterial and venous whole blood in PICO A and safePICO A for each parameter, measuring at five testing timepoints measured in minutes (t=0, t=10, t=20, t=30, t=45).
Time Frame: One subject delivers blood samples to be measured over time (45 min.)
Secondary Outcomes
No secondary outcomes reported