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

NCT ID: NCT06823648

Last Updated: 2025-02-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 63 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-18
• Study Completion Date: 2024-10-28

Brief Summary

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.

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.

Conditions

Precision and Stability in Adult Arterial Whole Blood Contained in PICO70 and SafePICO for Each Parameter

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Arterial blood samplers with needles PICO70 and safePICO syringes

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Radiometer Medical ApS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Theis Skovsgaard Itenov, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Bispebjerg Hospital, Itensiv afsnit

Locations

Bispebjerg Hospital, Itensiv afsnit

København NV, , Denmark

Countries

Denmark

Other Identifiers

DC-086204

Identifier Type: -

Identifier Source: org_study_id