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临床试验/NCT07005310
NCT07005310尚未招募不适用

Ultra Long Peripheral Catheter Versus Accelerated Seldinger Technique Long Peripheral Catheter in Difficult Intravenous Access Patients: a Pragmatic Randomised Controlled Trial

University Ghent2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年7月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
2
主要终点
Dwell time

研究概览

简要总结

The aim of this study is to perform a comparative analysis of clinical outcomes associated with the use of an ultra-long peripheral catheter using (catheter-over-the-needle technique) versus an AST-long peripheral catheter in adult patients with difficult intravenous access (DIVA) in a real-world clinical setting. Specifically, the study will assess potential benefits, including longer mean catheter dwell time and improved catheter usability, as well as potential harms, such as increased incidence of catheter-related thrombosis, infections, phlebitis, infiltration, and unplanned catheter removal.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
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

  • Adult inpatients with DIVA, requiring placement of a long peripheral catheter, will be included in the study.
  • A digital request form for venous access must be completed by the treating physician at the ward.
  • Patients must be proficient in either Dutch or French
  • Patients must have decision-making capacity or be represented by a legal representative.

排除标准

  • Expected therapy duration of less than 24 hours
  • pregnancy
  • Need for central venous access
  • Inability to locate a deep peripheral vein in the upper extremity prior enrollment in the study
  • Veins located deeper than 1.6cm prior enrollment in the study
  • withdrawal of consent, or presentation at a time when study personnel are unavailable.

结局指标

主要结局

Dwell time

时间窗: Until study completion, an average of 14 days.

is defined as the duration between the date of catheter insertion and the date of its removal, expressed in hours.

次要结局

  • Number of Participants with Catheter related thrombosis(Until study completion, an average of 14 days.)
  • Number of Participants with Midline catheter related infections(Until study completion, an average of 14 days.)
  • Number of Participants with Phlebitis(Until study completion, an average of 14 days.)
  • Number of Participants with Loss of catheter usability(Until study completion, an average of 14 days.)
  • Number of Participants with Unplanned removal(Until study completion, an average of 14 days.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tim Torsy

Prof. Dr.

University Ghent

研究点 (2)

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