A Randomized Controlled Trial Comparing In-line Ultrasound Guided Subclavian Vein Catheterization With or Without Needle Guide.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Number of subclavian catheter insertions with >1 skin puncture
研究概览
简要总结
OBJECTIVES The primary objective is to compare if the addition of a needle guide can reduce the number of central venous catheter (CVC) insertions with >1 skin puncture in ultrasound-guided catheterization of the subclavian vein using the long-axis approach with an in-plane needling technique.
Secondary objectives include if this addition 1) decreases the frequency of mechanical complications (defined as bleeding, arterial puncture, arterial catheterization, nerve injury, pneumothorax), 2) increases the time when the needle is visible, 3) decreases the time until successful vessel punction, 4) decreases the number of needle redirections during the insertion, and 5) a comparison between the two groups regarding number of failed catheterizations.
DESIGN This is a prospective, randomised, controlled, parallel intervention study. Patients will be enrolled at Skåne University Hospital in Lund, Sweden. The trial is investigator-initiated and non-commercial.
POPULATION AND INTERVENTION Adults (18 years of age or older) in need of a subclavian CVC for any reason and able to give written informed consent will be included in the study provided no exclusion criteria is fulfilled.
OUTCOMES Primary outcome will be number of CVC insertions with >1 skin puncture. Secondary outcomes include comparison between the two groups regarding 1) the frequency of mechanical complications, 2) proportion of the insertion-time when the needle is visible on the ultrasound (US) screen, 3) time to successful vessel punction, 4) the number of needle redirections during the insertion, 5) number of failed catheterisations, 6) Feasibility of the needle guide evaluated with a questionair to the operators at the end of the study.
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 (Outcomes Assessor)
盲法说明
The researcher who will review the documented ultrasound movies and assess the secondary outcomes will be blinded. However, given the nature of the study neither the Care Provider or Investigators will be blinded for the group affiliation or the primary outcome
入排标准
- 年龄范围
- 18 Years 至 105 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients in need of a central venous catheter .
- •Clinical indication for the subclavian route which includes expected time of use >5 days.
- •Signed informed consent.
排除标准
- •Patient is deemed unsuitable for cannulation of the subclavian vein, based on a pre-procedural US examination by the operator, or due to unacceptable patient risk in case of mechanical complication (e.g., severe respiratory failure).
结局指标
主要结局
Number of subclavian catheter insertions with >1 skin puncture
时间窗: During the central venous catheterization, up to 3 hours after inclusion
Number of subclavian catheter insertions with \>1 skin puncture
次要结局
- The number of failed catheterizations(During the central venous catheterization, up to 4 hours after inclusion)
- Feasibility of the needle guide(Through the study period, anticipated 3 years)
- Needle visibility(During the central venous catheterization, up to 4 hours after inclusion)
- The frequency of mechanical complications(24 hours after the completion of the central venous catheterization)
- The number of needle redirections(During the central venous catheterization, up to 4 hours after inclusion)
- Time to successful vessel puncture(During the central venous catheterization, up to 4 hours after inclusion)
研究者
Thomas Kander
Associate Professor and Sponsor Investigator
Region Skane