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

NCT02449226 | Completed

• 1 other identifier: 2015-A00718-41
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

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).

Conditions

Critical Care; Electrolytes; Point-of-Care Systems

Outcome Measures

Primary Outcomes (3)

• 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

• Dumming regression analysis

  to describe the relation between the tested method and the reference method for electrolytes, glucose, hemoglobin and hematocrit.

  1 month

• Coefficient of correlation (Pearson)

  to describe the correlation between the tested method and the reference method for electrolytes, glucose, hemoglobin and hematocrit.

  1 month

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients staying in our ICU and equipped with an indwelling arterial catheter for whom clinicians prescribe together an arterial blood gas analysis and a biological laboratory analysis. The study will take place over a 1 month period. A total of 300 pairs of samples is targeted.

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Hôpital Européen Marseille: lead

Study Sites (1)

Service de REANIMATION, HOPITAL EUROPEEN MARSEILLE

Marseille, France

Location

Related Publications (2)

• 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.

  PMID: 2170059 BACKGROUND

• 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.

  BACKGROUND

Study Officials

• Jérôme ALLARDET-SERVENT, MD, MSc

  HOPITAL EUROPEEN MARSEILLE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D, M.Sc

Study Record Dates

• First Submitted: May 17, 2015
• First Posted: May 20, 2015
• Study Start: May 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: February 1, 2016
• Last Updated: February 23, 2016

Record last verified: 2016-02

Locations

FR (1)