Randomised Clinical Trial to Evaluate the Obtention of Blood Samples Through an Arterial Catheter to Monitor Glycose Levels
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Bacteremia episode originated from arterial catheter
研究概览
简要总结
The technique of blood samples extraction from the radial artery through an arterial catheter with a 3-way stopcock and automated washing with valve of fast flow is better than the one carried out through a fixed reusable arterial blood sample syringe and its manual washing because it shows a minor incidence of the complications originated from technical manipulation as infection, pseudo-aneurysm, ischemia or thrombosis of radial artery or obstruction of the catheter.
The purpose of this study is to evaluate the efficacy, in terms of adverse effects, of blood samples obtention using an arterial catheter with needless connector closed system or an arterial catheter with an arterial blood sample syringe.
Also a second purpose is to compare once a day (at the same time) the values of glycose blood levels between bedside glucometer determination of arterial catheter extraction and capillar puncture, and lab determination of glycose from venous puncture, in order to determinate fluctuation in glycose levels due to peripherical hypoperfusion or to vasoactive drugs received by these in-intensive care unit patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admission in intensive care unit
- •Insertion of a radial artery catheter for the invasive monitoring of haemodynamic pressure for a maximum of 5 days
- •Need of insulin therapy by an intravenous continuous perfusion
排除标准
- •Patients who do not accept to participate (or their relatives do not accept)
- •Patients with a medical limitation of effort therapy
- •Patients with FloTrac sensor from Edwards Lifesciences which does not allow to add a supplementary 3-way stopcock
研究组 & 干预措施
Manual and automated washing of the line
Place in the radial artery the system of invasive monitoring of the blood pressure (BD DTXPlus ™). Insert in line a second 3-way stopcock above the one that has the BD DTXPlus ™; this second 3-way stopcock will be called proximal key. On the distal 3-way stopcock key (the one of TM BD DTXPlus ™), put the needless connector included in the kit to make the extractions of blood. Connect an arterial blood sampling syringe on the proximal 3-way stopcock key. With the assembled system, it is necessary to print a curve of invasive determination of the blood pressure.
干预措施: Manual and automated washing of the peripherical lines (Procedure)
Automated washing of the line
Place in the radial artery the system of invasive monitoring of the blood pressure (BD DTXPlus ™). Insert in line a second 3-way stopcock above the one that has the BD DTXPlus ™; this second 3-way stopcock will be called proximal key. On the distal 3-way stopcock key (the one of BD DTXPlus™), put the needless connector included in the kit to make the extractions of blood. On the proximal 3-way stopcock key put a second identical needless connector: in the intervention group the two 3-way stopcock keys have, each one, a needless connector. With the assembled system, it is necessary to print a curve of invasive determination of the blood pressure.
干预措施: Automated washing of the peripherical lines (Procedure)
结局指标
主要结局
Bacteremia episode originated from arterial catheter
时间窗: At catheter's withdrawal (at seventh day of insertion or at any moment for any clinical reason)
Catheter-related bloodstream infection as defined in Appendix A of "Guidelines for the Prevention of Intravascular Catheter-Related Infections". Centers for disease control and prevention (CDC) 2002 August 9: 51(RR10); 27.
次要结局
- Radial artery pseudo-aneurysm(Between 48 and 96 hours after catheter's withdrawal)
- Glycose blood levels(During the two days of catheter manipulation)
- Arterial catheter obstruction(From the date of arterial catheter insertion to withdrawal at seventh day or at any moment for any clinical reason)
- Catheter colonization(At catheter's withdrawal (at seventh day of insertion or at any moment for any clinical reason))
- Local infection at cutaneous point of arterial catheter insertion(At catheter's withdrawal (at seventh day of insertion or at any moment for any clinical reason))
- Ischemia or thrombosis of radial artery(Between 48 and 96 hours after catheter's withdrawal)