跳至主要内容
临床试验/NCT03890146
NCT03890146终止不适用

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

Fondation Ophtalmologique Adolphe de Rothschild1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2018年12月20日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
1
试验地点
1
主要终点
concordance between capillary and veinous sampling for natremia result

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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)

结局指标

主要结局

concordance between capillary and veinous sampling for natremia result

时间窗: 1 hour

The 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 result

时间窗: 1 hour

The 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 chloremiaresult

时间窗: 1 hour

The 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

次要结局

未报告次要终点

研究者

申办方类型
Network
责任方
Sponsor

研究点 (1)

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