25010 - ABL90 FLEX PLUS - Precision Capillary Adult - Clinical Study Protocol

Radiometer

Status: Not yet enrolling

Conditions: Diagnostic Tests

Treatments: Diagnostic Test: ABL90 FLEX PLUS analyser running SW3.5 MR2.

Study type: Observational

Funder types: Industry

Identifiers

NCT07307352

25010

Details and patient eligibility

About

Conducting the ABL90 FLEX PLUS Clinical Precision Study for 15 Parameters in Adult Whole Blood is to validate performance claims for precision in heparinized whole blood for 15 parameters: pH, pCO2, pO2, cCa2+, cCl-, cK+, cNa+, cGlu, cLac, ctHb, sO2, FO2Hb, FMetHb, FCOHb, and FHHb, while being influenced by testing environment that is representative of intended use environment, site variability, and operator variability in a point-of-care (POC) setting.

The investigational device is the ABL90 FLEX PLUS (Figure 1) incl. consumables, running SW3.5 MR2, manufactured by Radiometer Medical ApS The study is being conducted in Denmark and in total, a minimum of 30 subjects are to be enrolled to provide successful measurement values from 2 sites.

Full description

Adult Whole Blood is to validate performance claims for precision in heparinized whole blood for 15 parameters: pH, pCO2, pO2, cCa2+, cCl-, cK+, cNa+, cGlu, cLac, ctHb, sO2, FO2Hb, FMetHb, FCOHb, and FHHb, while being influenced by testing environment that is representative of intended use environment, site variability, and operator variability in a point-of-care (POC) setting.

Capillary blood collected into 2 capillary tubes from 2 distinct finger sticks will be measured on ABL90 FLEX PLUS in the Capillary mode (C65).

The study is designed to collect approximately 30 pairs of samples combined across sites.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The subject must be 18 years or older.
• Subjects must be able to understand given information and demonstrate willingness and ability to voluntarily give a signed, valid written informed consent to participate in the study.
• Subject evaluated as suitable according to the protocol to enroll in the study by the principal investigator or designee

Exclusion criteria

• Subject where sample collection is evaluated by principal investigator or designee to impose an unnecessary risk.

• Subject, with known pregnancy or breastfeeding.

• Subject, who has an invalid written informed consent or has withdrawn consent.

• Subjects who have been previously enrolled in the study.

• Subjects exposed to following substances within the last 72 hours:

  • Acetylsalicylic Acid Sodium Salt at dose equal or above 1 gram/day
  • N-acetylcysteine o Fluorescein dye o Patent Blue dye -