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Clinical Precision and In-use Analyte Stability Study for Four (4) Parameters in Neonate Arterial Blood for PICO70 and SafePICO

NCT06702267 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 56

Last updated 2024-11-22

No results posted yet for this study

Summary

The objective is to determine the total (within-lot and between lots) precision for four (4) parameters (pO2, tBil, ctHb and FHbF) in neonatal arterial blood. Furthermore, the objective is to determine the analyte in-use stability for each blood gas syringe in arterial blood for neonatal blood parameters.

In-use analyte stability in neonatal arterial blood in PICO70 and safePICO for each parameter, measuring at four testing timepoints.

It is expected that he precision performance of each parameter is equal to or within the acceptance criteria/performance claim.

The in-use analyte stability measured at four testing timepoint is within the acceptance criteria.

Conditions

  • Measure the Precision and Stability in PICO70 and SafePICO Over Time

Interventions

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.

Sponsors & Collaborators

  • Radiometer Medical ApS

    lead INDUSTRY

Principal Investigators

  • Maria Jeppegaard, PI · External Coordinating Principal Investigator

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-12
Primary Completion
2024-03-04
Completion
2024-03-04

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06702267 on ClinicalTrials.gov