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Concordance of Capillary Blood Biological Samples With Conventional Venousbiological Blood Samples.

Concordance of Capillary Blood Biological Samples Analyzed in Delocalized Biology With Conventional Venous Biological Blood Samples Analyzed at the Biology Laboratory

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03890146
Acronym
CAPIVEIN
Enrollment
1
Registered
2019-03-26
Start date
2018-12-20
Completion date
2020-12-21
Last updated
2021-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biochemical Dysfunction

Keywords

intensive care, capillary sampling, veinous sampling, natremia, kalaemia, Chloremia

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.

Interventions

None listed

Sponsors

Fondation Ophtalmologique Adolphe de Rothschild
Lead SponsorNETWORK

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
concordance between capillary and veinous sampling for natremia result1 hourThe concordance between the biological results obtained by capillary puncture analysed on the GEM 4000 resuscitation machine (Werfen), and the biological results by venous sampling analysed in the standard biology laboratory on the Gen. 2 COBAS machine (Roche) for natremia
concordance between capillary and veinous sampling for kalemia result1 hourThe concordance between the biological results obtained by capillary puncture analysed on the GEM 4000 resuscitation machine (Werfen), and the biological results by venous sampling analysed in the standard biology laboratory on the Gen. 2 COBAS machine (Roche) for kalemia
concordance between capillary and veinous sampling for chloremiaresult1 hourThe concordance between the biological results obtained by capillary puncture analysed on the GEM 4000 resuscitation machine (Werfen), and the biological results by venous sampling analysed in the standard biology laboratory on the Gen. 2 COBAS machine (Roche) for chloremia

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026