Comparison of blood gas measurement methods using ABL90 FLEX PLUS
ABL90 FLEX PLUS Method Comparison Study for pH, pCO2, pO2, cCa2+, cCl-, cK+, cNa+, cGlu, cLac, ctHb, sO2, FO2Hb, FMetHb, FCOHb and FHHb in Whole Blood in Adult Population.
This study is testing a new blood gas measurement device called ABL90 FLEX PLUS to see if it gives accurate results compared to an older device using blood samples from different sources.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 360 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Radiometer Medical ApS Industry-sponsored |
| Locations | 1 site (Sacramento, California) |
| Trial ID | NCT06078956 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to validate the performance of the ABL90 FLEX PLUS device for measuring various blood gas parameters in a Point of Care setting. It will compare results from the ABL90 FLEX PLUS with a predicate device using blood samples from both arterial and venous sources, as well as capillary samples. The study will focus on 15 specific analytes, ensuring accurate and reliable measurements for clinical use. Participants will provide blood samples through existing lines or finger sticks, and the study will assess the device's effectiveness across different sample types.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 years or older who can provide informed consent and blood samples.
Not a fit: Patients who are pregnant, breastfeeding, or have conditions that pose unnecessary risks during sample collection will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy and reliability of blood gas measurements in clinical settings, leading to better patient management.
How similar studies have performed: Other studies have shown success in validating blood gas measurement devices, indicating that this approach is supported by prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The subject must be 18 years or older. * Informed consent collected 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. * The subject will provide blood samples from the existing Aand/ or V-lines, and/or from a finger stick. * Subject evaluated as suitable according to the protocol to enroll in the study by principal investigator or designee. Exclusion Criteria: * Subject where sample collection is evaluated by principal investigator or designee to impose an unnecessary risk. * Subject, who is pregnant or breastfeeding. * Subject, who has an invalid written informed consent or has withdrawn consent. * Subject who has already provided successful measurements of arterial, venous and capillary samples, to cover both syringe modes and the capillary mode * Subjects taking medications listed in Appendix 1 with last dose within 72 hours, should be excluded due to interference. * Subjects with known infectious disease such as Hepatitis C and HIV (in order to ensure the operator safety).
Where this trial is running
Sacramento, California
- UC Davis — Sacramento, California, United States (Recruiting)
Study contacts
- Study coordinator: Lone GJ Pedersen, PhD
- Email: lone.graasboljuulpedersen@radiometer.dk
- Phone: +4528989640
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.