跳至主要内容
临床试验/NCT06365528
NCT06365528招募中不适用

Tunneled Versus Non-Tunneled Peripherally Inserted Central Catheter and Their Effects on Reducing Combined or Isolated Outcomes (Obstruction, Infection, Thrombosis, and Dislodgement): Multicenter Randomized Clinical Trial

Hospital de Clinicas de Porto Alegre1 个研究点 分布在 1 个国家目标入组 840 人开始时间: 2024年5月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
840
试验地点
1
主要终点
End of therapy or catheter removal free from complications

研究概览

简要总结

The aim of this multicenter randomized clinical trial is to compare the tunneling technique of PICC insertion with the non-tunneled insertion technique in the incidence of the combined or isolated outcome of catheter-related bloodstream primary infection, thrombosis, obstruction, and accidental dislodgement in the adult population within a period of up to 30 days.

详细描述

The data published this year from a multicenter study in Brazil presenting the patterns of use and clinical outcomes of PICC indicated that centers with vascular access teams, adoption of best practices, and current technologies result in low rates of complications, such as primary bloodstream infections related to the catheter, deep vein thrombosis, and reversible occlusion. Despite these more recent data showing that complications related to PICC can be mitigated by the use of technology, vascular access teams, adoption of best practices, and infection control measures, there is still room to incorporate new techniques in PICC insertion with the aim of further reducing avoidable complications. For example, recent studies with robust methodology have demonstrated the benefit of the tunneling technique compared to the conventional insertion technique. A randomized clinical trial showed that the dwell time of the device inserted using the tunneling technique was longer compared to the conventional technique without tunneling in adult patients, along with a lower incidence of thrombosis and infection. At the Hospital de Clínicas de Porto Alegre, recently, nurses from the PICC Team were trained in the tunneling technique at a reference center in Brazil. The initial results of tunneling in adult, pediatric, and neonatal patients are encouraging.

The observed results of implementing the technique indicate that there is potential to reduce avoidable complications and prompt us to propose a multicenter randomized controlled trial involving two additional institutions with similar profiles regarding the composition of Vascular Access Teams, adoption of best practices related to catheter care, and active ongoing education. To our knowledge, robust studies of this nature are not currently being conducted in Brazil.

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
Single (Outcomes Assessor)

盲法说明

Prospective Randomized Open, Blinded End-point (PROBE Study)

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

  • adult patients (>= 18 years old) admitted to medical clinics, surgical clinics, or ICU, who have an indication for PICC insertion;

排除标准

  • patients with Chronic Kidney Disease, whether dialytic or not;
  • patients in critical or unstable condition characterized by the need for intubation, respiratory rate <8 or >35 breaths per minute, oxygen saturation <90%, heart rate <40 or >140 beats per minute, systolic blood pressure <90mmHg, decreased Glasgow Coma Scale >2 points, or prolonged (>5 minutes) or repeated seizures;
  • patients with cognitive deficits that impair their understanding of the study and do not have a responsible party to assist in this stage.

结局指标

主要结局

End of therapy or catheter removal free from complications

时间窗: Up to 30 days

Time in days

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验