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临床试验/NCT02932800
NCT02932800Unknown不适用

Fixing the Short Stay Central Venous Catheter: Comparison of Two Techniques

Universidade do Vale do Sapucai2 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2015年11月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
62
试验地点
2
主要终点
Changes in catheter fixation

研究概览

简要总结

Context: The central venous catheter is used in intensive care units for several indications, including the administration of drugs with sclerosis potential, infusion solutions and hemodynamic monitoring. It can be accessed by per cutaneous puncture using the Seldinger technique, which is an extremely common procedure in intensive care units. The displacement or accidental removal of central venous catheter caused by poor fixation have received little attention, but imply potentially life threatening caused by the complications which can result from the removal of the catheter and the need for reinsertion. Among these complications, can mention the interruption of vital therapies (inotropic and vasopressor drugs) and hemorrhagic shock. In fixing the catheter, the literature is not sufficient to assess whether sutures, staples or tapes are associated with a higher risk of infections. Objective: To compare the efficiency in fixing the short stay central venous catheter using the "Ballerina" technique associated with flap fixation to the usual fixation technique and to observe differences in colonization of microorganisms on the device insertion site. Methods: The investigators propose an individual study, analytical, intervention, longitudinal, prospective, controlled clinical trial and randomized to be developed in the Intensive Care Unit Adult Clinical and Surgical of The Samuel Libânio Clinical Hospital in The University of Sapucaí Valley and Intensive Care Unit Adult Clinical and Surgical of The Hospital e Maternity Santa Paula. After admission of the patient in the Intensive Care Unit and obtaining informed consent and informed, with indication of the short stay central venous catheter, the patient will be allocated through a table of random numbers for the groups: Habitual Fixation (n = 31) and Fixation with "ballerina" technique and flip (n = 31). The participants will evaluate fixation efficiency and colonization of the device's insertion site.

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 (Participant)

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

  • Patients with indication for the use of central venous catheters ;
  • Both genders ;
  • Age greater than 18 years;
  • Admitted to the intensive care unit;
  • Informed Consent signed ( by the patient or family ) ;

排除标准

  • Device repositioning Need for abnormal pathway or malposition after installation;
  • No more indication of the central venous catheter use before the minimum period of 03 days ;

结局指标

主要结局

Changes in catheter fixation

时间窗: The evaluation will be on the third and fifth day after implantation

traction, kicking off, fixing loss of the device

次要结局

未报告次要终点

研究者

发起方
Universidade do Vale do Sapucai
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mário Lúcio Marques Leal

MD

Universidade do Vale do Sapucai

研究点 (2)

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