Diagnostic TestNCT05804487
ABL90 FLEX PLUS Clinical Precision Study for 15 Parameters in Adult Whole Blood
An observational study of Diagnostic Test, run by Radiometer Medical ApS at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diagnostic Test
- What is being tested?
- ABL90 FLEX PLUS analyser running SW3.5 MR2.
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 14 Mar 2023to 31 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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:
- Samples collected from 20 subjects (patients).
- 6 samples of whole blood are collected from each subject (3 samples for Run 1 and 3 samples for Run 2).
- Minimum 40 whole blood samples to be measured in S65 syringe mode (20 subjects x 2 samples per subject).
- Minimum 40 whole blood samples to be measured in SP65 short-probe mode (20 subjects x 2 samples per subject).
- Minimum 40 whole blood samples to be measured in C65 capillary mode (20 subjects x 2 samples per subject).
- Minimum 120 whole blood samples to be measured in all 3 modes free of errors. If errors occur, a new sample needs to be collected.
Part 2:
- Samples collected from 15 subjects (patients or donate blood).
- 9 samples of whole blood are collected from each subject. (3 samples in S65 mode, 3 samples in SP65 mode, 3 samples transferred into 6 capillary tubes in C65 mode).
- Minimum 45 whole blood samples to be measured in S65 syringe mode (15 subjects x 3 samples per subject).
- Minimum 45 whole blood samples to be measured in SP65 short-probe mode (15 subjects x 3 samples per subject).
- Minimum 45 whole blood samples to be measured in C65 capillary (15 subjects x 3 samples per subject).
- Minimum 135 whole blood samples to be measured in all 3 modes free of errors. If errors occur, a new sample needs to be collected.
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.
- Conditions
- Diagnostic Test
- Being tested
- ABL90 FLEX PLUS analyser running SW3.5 MR2.
- Keywords
- Blood gas
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 - 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start14 Mar 2023
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diagnostic TestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radiometer Medical ApS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tejs Jansen, Principal investigator, External Coordinating Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05804487
- Sponsor's protocol ID
- DC-084059
- Status last verified
- Dec 2022
- First submitted
- 26 Mar 2023
- Last updated
- 15 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: When the Clinical Study Report has been finalized, Data result will be available for public on platforms and in articles.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ABL90 FLEX PLUS Clinical Precision Study for 15 Parameters in Adult Whole Blood
- ClinicalTrials.gov ID
- NCT05804487
- Acronym / sponsor ID
- DC-084059
- Conditions
- Diagnostic Test
- Keywords
- Blood gas
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Radiometer Medical ApSIndustry (pharma, biotech, devices)
- Study start
- 14 Mar 2023 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 7 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Samples collected from 20 subjects (patients).
- 6 samples of whole blood are collected from each subject (3 samples for Run 1 and 3 samples for Run 2).
- Minimum 40 whole blood samples to be measured in S65 syringe mode (20 subjects x 2 samples per subject).
- Minimum 40 whole blood samples to be measured in SP65 short-probe mode (20 subjects x 2 samples per subject).
- Minimum 40 whole blood samples to be measured in C65 capillary mode (20 subjects x 2 samples per subject).
- Minimum 120 whole blood samples to be measured in all 3 modes free of errors. If errors occur, a new sample needs to be collected.
Part 2:
- Samples collected from 15 subjects (patients or donate blood).
- 9 samples of whole blood are collected from each subject. (3 samples in S65 mode, 3 samples in SP65 mode, 3 samples transferred into 6 capillary tubes in C65 mode).
- Minimum 45 whole blood samples to be measured in S65 syringe mode (15 subjects x 3 samples per subject).
- Minimum 45 whole blood samples to be measured in SP65 short-probe mode (15 subjects x 3 samples per subject).
- Minimum 45 whole blood samples to be measured in C65 capillary (15 subjects x 3 samples per subject).
- Minimum 135 whole blood samples to be measured in all 3 modes free of errors. If errors occur, a new sample needs to be collected.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABL90 FLEX PLUS analyser running SW3.5 MR2.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. | Device | – |
Primary outcome
Repeatability (SD) in whole blood for each parameter, measuring mode and parameter level, pooled across sites.
Time frame: 4 - 6 hours
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- Individual participant dataSharing planned: Yes. When the Clinical Study Report has been finalized, Data result will be available for public on platforms and in articles.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tejs Jansen principal investigator
External Coordinating Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diagnostic Test, run by Radiometer Medical ApS at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Repeatability (SD) in whole blood for each parameter, measuring mode and parameter level, pooled across sites. (time frame: 4 - 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2023.