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OpenTrials
Completed

NCT Number: NCT02449226

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de REANIMATION, HOPITAL EUROPEEN MARSEILLE

Marseille, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. bias and limit of agreement

    Time frame: 1 month

    to describe the bias and limit of agreement between the tested method and the reference method for electrolytes, glucose, hemoglobin and hematocrit.

  2. Dumming regression analysis

    Time frame: 1 month

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

  3. Coefficient of correlation (Pearson)

    Time frame: 1 month

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

Sponsors and collaborators

Lead sponsor

Hôpital Européen Marseille

Other

Registry information

Official study title

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

Acronym: (POCREA)

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
May 20, 2015
Registry last updated
Feb 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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