Critical Care, Intensive Care
Conditions
Keywords
PICO A, safePICO A, Stability
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.
Interventions
DEVICEAspirating syringes PICO A and safePICO A
PICO A: The PICO A is a pre-heparinized, aspirating blood syringe. The PICO A covers a volume range of 0.5-1.0 mL. The PICO A consists of a barrel, plunger, and a piston. PICO A is supplied with a heparinized paper brick within the barrel. The function of the heparin brick is to minimize coagulation of blood within the blood gas syringe. In addition, the syringe is delivered with a tip cap to reduce the risk of blood contact during blood mixing and sample transportation. safePICO A: The safePICO A is a pre-heparinized, aspirating blood syringe. The syringe consists of a barrel, plunger, and piston. It contains a mixing ball that supports automatic blood mixing when inserted in the sample mixing inlet integrated in the ABL90 FLEX PLUS analyzer. The safePICO A covers a volume range of 0.7-1.0 mL. The syringe includes a vented tip cap (VTC), which simplifies removal of air bubbles and minimize the risk of contact with patient blood by sealing the sample.
Sponsors
Radiometer Medical ApS
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects must meet all the criteria listed below to be eligible for participation in the study. 1. Subject must be 18 years of age or older. 2. Subject must have an arterial and/or venous line established as a part of the standard of care. 3. 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. 1. Subjects, who are pregnant or breastfeeding. 2. Subjects who have been previously enrolled into this study. 3. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | One subject delivers blood samples to be measured over time (45 min.) |
Countries
Denmark
Outcome results
None listed