Zeus (510K) - 24024 - Stability in Venous and Arterial Blood

Radiometer

Status: Terminated

Conditions: Critical Care, Intensive Care

Treatments: Device: Aspirating syringes PICO A and safePICO A

Study type: Observational

Funder types: Industry

Identifiers

NCT07491731

DC-091350

Details and patient eligibility

About

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.

Full 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.

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

43 participants in 1 patient group

PICO A and safePICO A

Description:

Observational, prospective study

Treatment:

Device: Aspirating syringes PICO A and safePICO A