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

NCT06823648 | Completed

• 1 other identifier: DC-086204
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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.)

Study Arms (1)

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

Interventions

Arterial blood samplers with needles PICO70 and safePICO syringes 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.

Adult patients, critically ill and 18 years or older

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Radiometer Medical ApS: lead

Study Sites (1)

Bispebjerg Hospital, Itensiv afsnit

København NV, 2400, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Arterial blood samples collected and destroyed immediately after measurements.

Study Officials

• Theis Skovsgaard Itenov, MD, PhD

  Bispebjerg Hospital, Itensiv afsnit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: February 12, 2025
• Study Start: June 18, 2024
• Primary Completion: October 28, 2024
• Study Completion: October 28, 2024
• Last Updated: February 12, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 4 months in Q4 2025 - Q1 2026.

Locations

DK (1)