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

Completed

• Conditions: Point-of-Care Systems; Electrolytes; Critical Care

• Registration Number: NCT02449226
• Lead Sponsor: Hôpital Européen Marseille

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-05-17
• Study First Submitted QC: 2015-05-19
• Study First Posted: 2015-05-20
• Primary Completion: 2015-06
• Status Verified: 2016-02
• Study Completion: 2016-02
• Last Update Submitted: 2016-02-21
• Last Update Posted: 2016-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Service de REANIMATION, HOPITAL EUROPEEN MARSEILLE; 🇫🇷 Marseille, France