Clinical trial NCT03890146: Concordance of Capillary Blood Biological Samples With Conventional Venousbiological Blood Samples.
Official title: Concordance of Capillary Blood Biological Samples Analyzed in Delocalized Biology With Conventional Venous Biological Blood Samples Analyzed at the Biology Laboratory
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Biochemical Dysfunction
Keywords: intensive care
capillary sampling
veinous sampling
natremia
kalaemia
Chloremia
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2019-03-26
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients hospitalized in the intensive care unit for any reason

Brief summary: The main objectives are to evaluate the concordance between the results of natremia, kalaemia and blood sugar levels obtained 1) by capillary puncture, analysed on a delocalized resuscitation machine GEM 4000 (Werfen) and 2) by venous sampling, analysed on the machine of the standard biology laboratory Gen. 2 COBAS (Roche).

Detailed description: The completion of a biological test suits a succession of codified steps:

* Medical prescription
* The pre-analytic phase (preparation of the material, completion of the sample, transport of the sample and preparation of it)
* The analytical phase
* The post-analytic phase (validation of the result obtained and the dissemination of it to the prescriber, usually the clinician, who is then able to make a medical decision) This succession of steps involves, as part of a classical journey, many stakeholders (doctors, nurses, couriers, laboratory technicians, medical biologists) in different places.

Outsourced biology (care test point, POCT) refers to the analysis of biological samples outside the central laboratory. The sample is most often carried out, transported and analyzed by the same person on a machine near the patient or in the service and therefore in the absence of direct control of a specialized laboratory technician or a medical biologist, who remains however responsible for good practice, maintenance of the device and validity of the results.

The completion of biological examinations is regulated by differents Articles. The outsourced biology (ADBD) sampling analysis can be carried out in the hospital, in most departments, and also outside the hospital (pharmacies, city offices or even in the patient's own home). On portable devices, usually highly specialized, and these fixed allowing a greater diversity of tests.

Its development is booming with annual growth estimated in 2006 at 15.5% in the United States.

Eligibility criteria: Inclusion Criteria:

* Patient over the age of 18
* Affiliate or beneficiary of a social security scheme
* Express consent to participate in the study

Exclusion Criteria:

* Patient benefiting from a legal protection measure
* Patient not communicating
* Pregnant or breastfeeding woman
* Peripheral edema (taking more than 5 Kg since entering the service)
* Patient in shock (mean arterial pressure \< 65 mmHg or continuous catecholamine administration)

Primary outcomes:
measure: concordance between capillary and veinous sampling for natremia result
timeFrame: 1 hour
measure: concordance between capillary and veinous sampling for kalemia result
timeFrame: 1 hour
measure: concordance between capillary and veinous sampling for chloremiaresult
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: France
Study officials:
affiliation: Fonadtion Afolphe Rothschild
name: Nefeli Nasika
role: PRINCIPAL_INVESTIGATOR
References: