跳至主要内容
临床试验/NCT06043895
NCT06043895尚未招募不适用

The Overall Surgical Time Comparison Between EpiFaith® CV and Conventional Syringe in Central Venous Catheterization

National Taiwan University Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年9月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
2
主要终点
The overall surgical time

研究概览

简要总结

EpiFaith CV provides automatic aspiration and detection of arterial pressure as an alternative to manometry in central venous catheterization. The aim of the study is to evaluate if it may reduce operation time compared with conventional syringe.

详细描述

Central venous catheterization (CVC) is crucial in modern perioperative and intensive care. Keeping constant and stable negative pressure while advancing the needle had been issue for beginners. Recently, EpiFaith CV provides a new solution for CVC, which facilitates syringe control and precision during assessing vessels. It provides steady aspiration and detection of arterial pressure as an alternative to manometry without the need to disconnect nor more connections. The aim of the study is to evaluate if it may reduce operation time compared with conventional syringe.

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
Double (Participant, Investigator)

盲法说明

The care providers (conducting physicians) and the research assistants who observe and record the results will know the assignments, while the participants and data analysts will not know the assignments.

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

The overall surgical time

时间窗: 1 hour

The time from needle insertion, aspiration of blood, assessment of vein or artery, insertion of guidewire, until removal of the needle

次要结局

  • Likert scale for satisfaction(1 hour)
  • Success rate(1 hour)
  • Number of attempts to place guidewire(1 hour)
  • Arterial puncture rate(1 hour)
  • Arterial puncture identification rate(1 hour)
  • Amount of blood drawn(1 hour)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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EpiFaith CV for Central Venous Catheterization | 临床试验