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临床试验/NCT05763186
NCT05763186招募中不适用

The Right Amount of Purge Useful for Blood Sampling on PiccLine

Rennes University Hospital1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2024年5月18日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
66
试验地点
1
主要终点
Lowest purge volume to obtain a biological result in the PiccLine sample that matches the peripheral sample taken from the same patient at the same time for the following assays: - Sodium, potassium and chlorine - Creatinine - Glucose

研究概览

简要总结

An increasing number of patients are receiving central lines, including PiccLine systems for the administration of therapeutics and nutrition.

Although these systems are not theoretically intended for blood collection, nurses prefer them as a puncture site when they are in place in their patients, saving them from further peripheral puncture in people who generally do not have optimal venous capital.

It is essential to purge the tubing in place in the patient and filled with infusion solution before drawing blood. Although the dead volume of the tubing used does not exceed 2mL, the volume of purging required before filling tubes for the laboratory appears to be much greater. Anecdotal evidence suggests a useful volume of 20ml but this has never been clearly demonstrated. In addition, the Biochemistry laboratory regularly sees blood samples diluted with perfusion solution, as evidenced by biochemical assays, leading to the cancellation of analyses received in the laboratory and a new sample being taken. This increases blood spoliation for these often already anaemic patients.

There is no consensus in the literature on recommendations for such sampling in PiccLine patients:

  • The CLSI1 (Clinical and Laboratory Standart Institute), a non-governmental organisation, issued sampling recommendations in 2017 that were taken up by Becton Dickinson2, a supplier of blood collection tubes. These recommendations include:

  • Rinse with 10 ml of 0.9% NaCl

  • Then a purge of 3 to 11 ml (depending on the analysis sought)

  • English-language articles3,4,5,6,7 show purge volumes ranging from 3 to 6 ml with significantly different sampling methods (rinsing or not).

The investigators therefore note a discrepancy between the sampling practices of the university hospital and the recommendations of the CLSI. In fact, the investigators noted a lack of rinsing prior to purging, which could explain the difference between 20 and 3 ml. This raises the issue of protocolisation of this type of sampling in order to standardise practices.

A consultation of other hospitals, carried out beforehand, enabled us to note that French practices are not in agreement with these recommendations. The management of the Rennes University Hospital as well as the Haute Autorité de Santé were contacted in order to confirm that no normative document had been published or was being drafted on this subject.

The fields of study are: sampling practices on PiccLine, the pre-analytical phase in medical biology.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

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

  • Age ≥ 18 years
  • Carrier of PiccLine one way polyurethane
  • Hospitalized in a clinical hematology unit This criterion minimises patient and practice heterogeneity.
  • PiccLine placement not older than 48 hours
  • Injection of at least one solution
  • Affiliated to a social security scheme
  • Having signed a free, informed and written consent

排除标准

  • Anemia below the transfusion threshold (hemoglobin level < 7 g/dL) in relation to the patient's pathology
  • Parenteral nutrition
  • Peripheral venous sampling not possible (insufficient venous capital)
  • Protected person (adult subject to legal protection (safeguard of justice, curatorship, guardianship), person deprived of liberty, pregnant woman (declarative), breastfeeding woman and minor).

结局指标

主要结局

Lowest purge volume to obtain a biological result in the PiccLine sample that matches the peripheral sample taken from the same patient at the same time for the following assays: - Sodium, potassium and chlorine - Creatinine - Glucose

时间窗: during 2 days follow-up

次要结局

未报告次要终点

研究者

发起方
Rennes University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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