ABL90 FLEX PLUS Clinical Precision Study for 15 Parameters in Adult Whole Blood

NCT05804487 | Completed FDA Device

• 1 other identifier: DC-084059
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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 105 subjects are to be enrolled to provide successful measurement values from 3 different sites.

Conditions

Diagnostic Test

Keywords

Blood gas

Outcome Measures

Primary Outcomes (1)

• Repeatability (SD) in whole blood for each parameter, measuring mode and parameter level, pooled across sites.

  Repeatability 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 syringe, short probe, and capillary modes available for ABL90 FLEX PLUS, in a POC setting.

  4 - 6 hours

Interventions

ABL90 FLEX PLUS analyser running SW3.5 MR2. DEVICE

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients (≥18 years old ) admitted to the hospital with low (moderate hypo), normal, or elevated (moderate hyper) concentrations of the 15 parameters covering the reportable range as much as possible. For collecting whole blood samples, the subject is required to have either arterial or Central Venus Catheter (CVK) lines established as part of standard of care to minimize the risk to the patient.

You may qualify if:

• Subject must be 18 years of age or older.
• Obtained informed consent from subject or from relative(s) able to understand information given and willing and able to voluntary give their consent to participate in this study.
• Subject shall have an arterial or a CVK line established as a part of the standard care.
• Subject evaluated as suitable according to the protocol and for the study by the principal investigator or designee.

You may not qualify if:

• Subjects where sample collection is evaluated by principal investigator or designee to impose an unnecessary risk.
• Subjects, who are pregnant or breastfeeding.
• Subjects who have been previously enrolled into this study.
• Subjects taking medications listed in Appendix 1 within 72 hours of the sample collection
• Subjects with known infectious disease such as Hepatitis C or HIV (to ensure the operator safety)

Sponsors & Collaborators

• Radiometer Medical ApS: lead

Study Sites (1)

Tejs Jansen

Copenhagen, Østerbro, 2100, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Samples are collected to measure the pH, pCO2, pO2, cCa2+, cCl-, cK+, cNa+, cGlu, cLac, ctHb, sO2, FO2Hb, FMetHb, FCOHb and FHHb parameters in adult whole blood. Samples are destroyed when measurements are completed.

Study Officials

• Tejs Jansen

  External Coordinating Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 26, 2023
• First Posted: April 7, 2023
• Study Start: March 14, 2023
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: September 15, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: The data will become available within a year after end of study.

Locations

DK (1)