An observational study in Diagnostic Test, sponsored by Radiometer Medical ApS. Completed at 1 site in Denmark. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-15.
Sponsored by Radiometer Medical ApS (part of Danaher Corporation) · Observational
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.
The conduct of the clinical study is to determine repeatability of each parameter 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.
The study endpoint is repeatability (SD) in whole blood for each parameter, measuring mode and parameter level, pooled across sites. Participating sites are intensive care wards, and the adult patients (≥18 years old ) are 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.
Each sample of 1.5 mL whole blood is used to complete 2 replicates per run (Each sample will be measured twice on the selected mode during 1 run). Samples to be measured in syringe mode are measured from a syringe, or samples to be measured in capillary mode are transferred to capillary tubes from a syringe and measured from a capillary tube.
Part 1:
Part 2:
Minimum 255 (heparinized) whole blood samples obtained from adult patients or donate blood are required for this study from each site.
This study will evaluate 2-3 levels per parameter covering the moderate hypo, normal and moderate hyper range.
Three POC users, such as a nurse, a physician, or a therapist perform the measurements in an equal range.
Samples are collected to measure the pH, pCO2, pO2, cCa2+, cCl-, cK+, cNa+, cGlu, cLac, ctHb, sO2, FO2Hb, FMetHb, FCOHb, and FHHb parameters in heparinized whole blood. Samples are destroyed when measurements are completed.
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.
Radiometer Medical ApS is the lead sponsor of 19 studies on the registry; 5 are open to participants now.
First submitted after Radiometer Medical ApS became part of Danaher Corporation.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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.
Time frame: 4 - 6 hours
Plan to share: Yes — When the Clinical Study Report has been finalized, Data result will be available for public on platforms and in articles.
Supporting information: Clinical study report
Time frame: The data will become available within a year after end of study.
No publications or documents are linked to this record.
Ran from Mar 2023 to primary completion in Aug 2023, 5 months.
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This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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