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

NCT ID: NCT03890146

Last Updated: 2021-01-29

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 1 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-12-20
• Study Completion Date: 2020-12-21

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.

Conditions

Biochemical Dysfunction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

intensive care patients

patient hospitalised in intensive care unit veinous and capillary ponction

No interventions assigned to this group

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nefeli Nasika

Role: PRINCIPAL_INVESTIGATOR

Fonadtion Afolphe Rothschild

Locations

France

Paris, , France

Countries

France

Other Identifiers

2018-A01880-55

Identifier Type: -

Identifier Source: org_study_id