Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT03890146 |
| Other study ID # |
2018-A01880-55 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 20, 2018 |
| Est. completion date |
December 21, 2020 |
Study information
| Verified date |
January 2021 |
| Source |
Fondation Ophtalmologique Adolphe de Rothschild |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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).
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.
