The Overall Surgical Time Comparison Between EpiFaith® CV and Conventional Syringe in Central Venous Catheterization
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 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
- 否
入选标准
- •(for participants):
- •18 years old and above
- •Surgical patients who need to have a central venous catheter placed
- •Informed and agree to participate in the study
- •Inclusion Criteria (for conducting physicians):
- •Physicians with >100 central venous catheter placement experience, including attending physicians and senior residents
排除标准
- •(for participants):
- •Patient refusal
- •Puncture site skin lesions
- •Uncorrected coagulation disorder
- •Hemodynamic instability
- •Not informed and consented to participate in research
- •Exclusion Criteria (for conducting physicians):
- •Not informed and consented to participate in research
研究组 & 干预措施
EpiFaith CV
The conducting physicians in this group will use EpiFaith CV to localize the central vein and assess if there is arterial puncture
干预措施: EpiFaith CV (Device)
Conventional
The conducting physicians in this group will use Raulerson syringe to localize the central vein and assess if there is arterial puncture
干预措施: Conventional (Device)
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)