Clinical Precision and In-use Analyte Stability Study for 19 Parameters in Adult Arterial Whole Blood for PICO70 and SafePICO

23002, Clinical Precision and In-use Analyte Stability Study for 19 Parameters in Adult Arterial Whole Blood for PICO70 and SafePICO

The purpose is to characterize the precision and in use stability of 19 parameters (pH, pCO2, pO2, cNa+, cCa2+, cCl-, cK+, cGlu, cLac, cUrea/BUN, cCrea, ctHb, sO2, FMetHb, FCOHb, FO2Hb, FHHb, FHbF & ctBil) in arterial blood drawn and stored in self-filling syringes (PICO70 and safePICO) across different lots of samplers measured on ABL90 FLEX PLUS analyzer.

The study aims to determine the total (within Lot and Lot-to-Lot) precision for the PICO70/safePICO in arterial whole blood. Furthermore, the study aims to determine the stability for up to 45 min. at room temperature (18-25 °C) for arterial blood sample analysis in the PICO70/safePICO for all 19 parameters.

Study Overview

• Status: Completed
• Conditions: Precision and Stability in Adult Arterial Whole Blood Contained in PICO70 and SafePICO for Each Parameter
• Intervention / Treatment: Device: Arterial blood samplers with needles PICO70 and safePICO syringes

Detailed Description

The study is a Post-Market Clinical Follow-up (PMCF) randomized unblinded study, expected to be conducted at two sites in Denmark using arterial whole blood samples collected from adult patients to determine the precision and stability for the PICO70/safePICO syringes when measuring 19 parameters (pH, pCO2, pO2, cNa+, cCa2+, cCl-, cK+, cGlu, cLac, cUrea/BUN, cCrea, ctHb, sO2, FMetHb, FCOHb, FO2Hb, FHHb, FHbF & ctBil) using the RMED ABL90 FLEX PLUS analyzer. The 19 parameters will be analysed for each syringe in the syringe series on the ABL90 FLEX PLUS analyzer. For PICO70: Approximately 40+4 (4 contrived sample series) completed series of arterial blood samples consisting of 6 syringes: The syringes will be from three different lots (A,B,C) and analyzed at four different time points, T0, T15, T30 and T45. For safePICO: Approximately 40+4 (4 contrived sample series) completed series of arterial blood samples consisting of 6 syringes: The syringes will be from three different lots (A,B,C) and analyzed at four different time points, T0, T15, T30 and T45. According to guidelines (CLSI GP34) samples should be distributed throughout the analytical measurement range of measurands evaluated. To ensure coverage of the full range for each parameter, it may be necessary to contrive some sample series.

• Study Type: Observational
• Enrollment (Actual): 63

Contacts and Locations

Study Locations

• Denmark
  • København NV, Denmark, 2400
    • Bispebjerg Hospital, Itensiv afsnit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult patients 18 years or older, critically ill, but still able to understand and sign the informed consent form and admitted to the hospital having an arterial catheter line established as part of standard of care to minimize the risk to the patient when having blood samples drawn.

To reach reportable concentrations of the 19 parameters covering the reportable range as much as possible the subject will be a patient in the intensive care unit or another unit corresponding to the emergency care.

Description

Inclusion Criteria:

Subject must be 18 years of age or older. Subject must have an arterial catheter line established as part of the standard of care.

Subject must be suitable for the study according to the protocol evaluated by the principal investigator or designee.

Exclusion Criteria:

Subject is unconscious or otherwise incapable of understanding and signing the informed consent form.

Subject must not have been previously enrolled into this study. Subject must not be known with pregnancy or breastfeeding.

Subject must not be taking the following medications within 72 hours prior to the sample collection:

Acetylsalicylic Acid Sodium Salt at dose equal or above 1 gram/day. Acetylcysteine drug used against paracetamol intoxication. Fluorescein dye (used for the diagnosis of ocular disease). Patent Blue dye (used to mark the lymphatic vessels, arterial territories, and lymph nodes prior to a biopsy).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Adult patients, critically ill and 18 years or older; One single group is included in the study for the investigation of the PICO70 and safePICO syringes.

Device: Arterial blood samplers with needles PICO70 and safePICO syringes; PICO70 is a self-filling syringe for sample volumes in the range of 0.3-1.5 mL. All syringes are delivered with needle cube for safe needle disposal and a standard tip cap to reduce the risk of blood contact during blood mixing and sample transportation. safePICO is a more advanced group of syringes based on the PICO70 family. They contain a gold coated magnetic steel ball facilitating automatic mixing of the blood when being used with the Radiometer ABL 90 with mixing module. The safePICO is a self-filling syringe covering a volume range of 0.7-1.5 mL and includes a vented safe tip cap (VTC), which simplifies removal of air bubbles and avoid the operator to get in contact with the blood, after attachment to the syringe. Some variants of safePICO are delivered with a needle shield device (NSD) to ensure safe removal of the needle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Precision in adult arterial whole blood in PICO70 and safePICO syringes for each parameter.	The objective is to determine the total (within-lot and between lots) precision for four (19) parameters (pH, pCO2, pO2, cNa+, cCa2+, cCl-, cK+, cGlu, cLac, cUrea/BUN, cCrea, ctHb, sO2, FMetHb, FCOHb, FO2Hb, FHHb, FHbF & ctBil) in arterial blood.	One subject delivers blood samples to be measured over time (45 min.)
In-use analyte stability in adult arterial whole blood in PICO70 and safePICO syringes for each parameter, measuring at four testing timepoints, T0, T15, T30 and T45.		One subject delivers blood samples to be measured over time (45 min.)

Collaborators and Investigators

• Sponsor: Radiometer Medical ApS
• Investigators: Principal Investigator: Theis Skovsgaard Itenov, MD, PhD, Bispebjerg Hospital, Itensiv afsnit

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2024
• Primary Completion (Actual): October 28, 2024
• Study Completion (Actual): October 28, 2024

Study Registration Dates

• First Submitted: November 19, 2024
• First Submitted That Met QC Criteria: February 6, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 6, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: DC-086204

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study results will be available to participating Investigators. The results are also available for supporting the safety and performance of the arterial blood syringes with needles, PICO70, safePICO70 and safePICO self-fill according to requirements.
• IPD Sharing Time Frame: 4 months in Q4 2025 - Q1 2026.
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No