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

N/ANot Yet RecruitingNCT07307352

Radiometer Medical ApS30 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Diagnostic Tests

Interventions

The ABL90 FLEX PLUS analyzer is a portable, automated analyzer that measures pH, blood gases, electrolytes, metabolites, and oximetry in whole blood - utilizing 3 measuring modes (syringe, short probe, and capillary mode) to measure samples from a syringe, test tube or a capillary tube. The analyzer provides results for 17 parameters in 35 seconds using 65 μL heparinized whole blood.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 -

Outcomes

Primary Outcomes

Within sample precision for each parameter measured in capillary mode pooled across sites.

Within sample precision of each parameter (pH, pCO2, pO2, cCa2+, cCl-, cK+, cNa+, cGlu, cLac, ctHb, sO2, FO2Hb, FMetHb, FCOHb and FHHb) using replicate measurements from heparinized whole blood samples measured by intended users in a POC setting.

Time frame: 1 hour

Secondary Outcomes

Within sample precision for each parameter measured in capillary mode per site, if applicable (at least 15 degrees of freedom shall be obtained for the estimate to be statistically meaningful).