Accuracy of Point-of-Care Measurement With the RapidPoint 500 Blood Gas Analyser

Critical Care Clinical Trial

— (POCREA)  

Official title:

Accuracy of Point-of-Care Measurement of Electrolytes, Glucose, Hemoglobin and Hematocrit With the RapidPoint 500 Blood Gas Analyser

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02449226
• Other study ID #: 2015-A00718-41
• Status: Completed
• Phase: N/A
• First received: May 17, 2015
• Last updated: February 21, 2016
• Start date: May 2015
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: Hôpital Européen Marseille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertésFrance: Committee for the Protection of Personnes
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: February 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Current stay in ICU

• Presence of an indwelling arterial catheter (radial or femoral)

• Prescription by physicians of a blood gas analysis and a laboratory analysis for the next morning

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Critical Care
• Electrolytes
• Point-of-Care Systems

Locations

Country	Name	City	State
France	Service de REANIMATION, HOPITAL EUROPEEN MARSEILLE	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital Européen Marseille

Country where clinical trial is conducted

France, 

References & Publications (2)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bias and limit of agreement	to describe the bias and limit of agreement between the tested method and the reference method for electrolytes, glucose, hemoglobin and hematocrit.	1 month	No
Primary	Dumming regression analysis	to describe the relation between the tested method and the reference method for electrolytes, glucose, hemoglobin and hematocrit.	1 month	No
Primary	Coefficient of correlation (Pearson)	to describe the correlation between the tested method and the reference method for electrolytes, glucose, hemoglobin and hematocrit.	1 month	No