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

NCT ID: NCT02449226

Last Updated: 2016-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

51 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-31

Study Completion Date

2016-02-29

Brief Summary

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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).

Detailed Description

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Conditions

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Critical Care Electrolytes Point-of-Care Systems

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

* None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hôpital Européen Marseille

OTHER

Sponsor Role lead

Responsible Party

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Jerome Allardet-Servent, MD

M.D, M.Sc

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jérôme ALLARDET-SERVENT, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

HOPITAL EUROPEEN MARSEILLE

Locations

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Service de REANIMATION, HOPITAL EUROPEEN MARSEILLE

Marseille, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 2170059 (View on PubMed)

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.

Reference Type BACKGROUND

Other Identifiers

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2015-A00718-41

Identifier Type: -

Identifier Source: org_study_id

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