(POCREA): Accuracy of Point-of-Care Measurement With the RapidPoint 500 Blood Gas Analyser
Study Details
Study Description
Brief Summary
ICU patients are at high risk of ionic or metabolic disturbances during the course of their critical illness. Some of these disturbances might be life-threatening and require rapid response from physicians. Point-of-Care determination of electrolytes, glucose, hemoglobin and hematocrit ensures early detection (within 1 minute) of abnormal values and allows rapid and appropriate therapy. This technology has largely improved the quality of care in ICU. However, the accuracy of the measurement of those parameters had to be close enough to the reference method, usually perfomed in the central lab but time consuming. Recently, a novel generation of blood gas analyser has been released. Among them, the RapidPoint 500 is mounted with a 28-day cartridge which provides automatic calibrations and quality controls several times a day. Such a technology dramatically decreases the need for labs technical interventions. To date, there is no data reporting the accuracy of this device. Therefore, the investigators' aim is to compare the accuracy of the RapidPoint 500 with a reference measurement performed at the central laboratory (Beckman&Coulter AU5800 for electrolytes and Beckman&Coulter DXH for hemoglobin).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- bias and limit of agreement [1 month]
to describe the bias and limit of agreement between the tested method and the reference method for electrolytes, glucose, hemoglobin and hematocrit.
- Dumming regression analysis [1 month]
to describe the relation between the tested method and the reference method for electrolytes, glucose, hemoglobin and hematocrit.
- Coefficient of correlation (Pearson) [1 month]
to describe the correlation between the tested method and the reference method for electrolytes, glucose, hemoglobin and hematocrit.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Current stay in ICU
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Presence of an indwelling arterial catheter (radial or femoral)
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Prescription by physicians of a blood gas analysis and a laboratory analysis for the next morning
Exclusion Criteria:
- None
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Service de REANIMATION, HOPITAL EUROPEEN MARSEILLE | Marseille | France |
Sponsors and Collaborators
- Hôpital Européen Marseille
Investigators
- Principal Investigator: Jérôme ALLARDET-SERVENT, MD, MSc, HOPITAL EUROPEEN MARSEILLE
Study Documents (Full-Text)
None provided.More Information
Publications
- Clinical and Laboratory Standards Institute (CLSI). Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline-Third Edition. CLSI document EP9-A3 (ISBN 1-56238-887-8). Wayne, Pennsylvania, USA, 2013.
- Ehrmeyer SS, Laessig RH, Leinweber JE, Oryall JJ. 1990 Medicare/CLIA final rules for proficiency testing: minimum intralaboratory performance characteristics (CV and bias) needed to pass. Clin Chem. 1990 Oct;36(10):1736-40.
- 2015-A00718-41