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The Influence of Nursing Technique Applied at the Central Venous Catheter Insertion Site Upon the Incidence of Infection

2019年3月13日 更新者:University Hospital Ostrava
Assessing the impact of the nursing technique applied at the insertion site of the central venous catheter using hydrophilic methacrylate gel (HMG) and 2% Chlorhexidine (CHG) upon the incidence of inflammatory complications when treating the surrounding of the central venous catheter.

研究概览

详细说明

The study was a prospective and randomized clinical trial. The study was performed at two departments of the University Hospital Ostrava.

The design and performance of the study were approved by the Ethics Committee of the University Hospital Ostrava.

The patients indicated for insertion of central venous catheter (CVC) were informed about the possible nursing techniques applied at the insertion site of the central venous catheter, participation in the study was conditioned with signing a written informed consent. The study evaluated the superiority of a new procedure in providing nursing care for patients with CVC.

Basic patient characteristics were observed and recorded according to the protocol of the study (age, sex, diagnosis), the number of days with CVC inserted, type of dressing, APACHE II score, the presence of neutropenia and the final score of assessment of local signs of inflammation, which was defined as follows:

0 points = No reddening

  1. point = Reddening below 2 mm in diameter around the incision
  2. points = Reddening below 5 mm in diameter around the incision
  3. points = Reddening exceeding 5 mm in diameter around the incision
  4. points = Purulent secretion, swelling, pain
  5. points = Catheter sepsis The investigators also recorded the day when the first signs of local infection were observed.

The obtained results were evaluated with standard statistical techniques (Chí-quadrate test, Fisher's exact test).

Upon inserting CVC, the type of draping was recorded (small, middle, large), and the cannulated vein (vena subclavia, left and right, vena jugularis interna, left and right, vena femoralis, left and right). A smear was obtained from around the incision site in all patients after insertion and after extraction; the smears were sent for microbiology cultivation and determination of sensitivity to antibiotic therapy. Changing of the dressings was performed in accordance with standard operating procedures of the University Hospital Ostrava. The CVC was attended under aseptic conditions, using sterile material. Surrounding of CVC was mechanically cleaned and disinfected using 2% chlorhexidine for disinfection of the skin, let to dry, and semipermeable foil was placed at the site, containing chlorhexidine gluconate. The dressing was identified with a date when it was applied. This was left in situ for 3-4 days, and the procedure was repeated.

The patients were randomized into two study groups:

  1. HMG Group - the patients were treated with 2% chlorhexidine for skin disinfection, HMG and transparent foil
  2. CHG Group - the patients were treated with 2% chlorhexidine for skin disinfection and dressing with CHG The randomization procedure further divided the patients into two study arms

1. Neutropenia Group (defined as the number of neutrophil granulocytes below 1x109/l 2. No-neutropenia Group (with a normal number of neutrophil granulocytes

研究类型

介入性

注册 (实际的)

221

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Moravian-Silesian Region
      • Ostrava、Moravian-Silesian Region、捷克语、70852
        • University Hospital Ostrava

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Age over 18 years
  • Patients with CVC
  • Hospitalization at ICU

Exclusion Criteria:

  • Allergy to HMG
  • Allergy to transparent foil
  • CVC insertion shorter than 3 days
  • Strong bleeding from CVC insertion site

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Neutropenia patients
Patients with neutropenia were treated using the CHG and HMG technique.
The CHG technique includes treatment using dressing with chlorhexidine.
The HMG technique includes treatment using hydrophilic methacrylate gel and transparent foil.
实验性的:No neutropenia patients
Patients with no neutropenia were treated using the CHG and HMG technique.
The CHG technique includes treatment using dressing with chlorhexidine.
The HMG technique includes treatment using hydrophilic methacrylate gel and transparent foil.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Local signs of inflammation
大体时间:3 days at minimum, up to 15 days
The local signs of inflammation were observed in both study arms and both interventions, and were assessed according to the scoring system described in detail description.
3 days at minimum, up to 15 days

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Kateřina Hašová, Mgr.、University Hospital Ostrava

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2016年2月1日

初级完成 (实际的)

2018年12月31日

研究完成 (实际的)

2018年12月31日

研究注册日期

首次提交

2019年3月10日

首先提交符合 QC 标准的

2019年3月13日

首次发布 (实际的)

2019年3月14日

研究记录更新

最后更新发布 (实际的)

2019年3月14日

上次提交的符合 QC 标准的更新

2019年3月13日

最后验证

2019年3月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • KHO-01-CVC
  • RVO-FNOs/2016 (其他赠款/资助编号:University Hospital Ostrava)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

The investigators have decided not to make individual participant data available to other researchers.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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