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临床试验/NCT04683302
NCT04683302已完成不适用

3D Biplane vs Conventional 2D Ultrasound Guided Internal Jugular VEin caNnulation in CardiotHoracic surgerY Patients

Catharina Ziekenhuis Eindhoven2 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2021年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
126
试验地点
2
主要终点
first pass success

研究概览

简要总结

Central venous catheterization through the jugular vein is a standard procedure for cardiothoracic surgical patients. Ultrasound (US) guidance is preferred and compared to traditional landmark approach decreases complications and increases success rate. Both long and short axis views are used for obtaining access, both with their own advantages and shortcomings. Complications have also not completely diminished with the use of US. The investigators propose a new technique using 3D biplanar imaging, combining advantages from both long and short axis views in one image, enabling more successful procedures and a lower complication rate

详细描述

Central venous catheters (CVC) are frequently placed in patients who are scheduled for cardiothoracic surgery (ICU). Ultrasound (US) guidance has consistently shown to not only improve success rate of procedures, but also to decrease complications with most benefit for the jugular vein. However, serious adverse events still occur despite US guidance Conventional two dimensional ultrasound (2D US) guided access if performed in either the short axis or long axis view, with both approaches having their own limitations. Using short axis view, the operator is never certain of the position of the needle tip as the shaft of the needle is not distinguishable from the tip in this view. Structures not (yet) visible in the US screen can already be punctured, or a vessel can be entered at a different position than preferred. A possible mechanism through which carotid artery puncture can happen is the posterior wall puncture4.

For long axis view, with proper technique the needle is viewed entirely during the procedure. However, this requires extensive experience and the overview of surrounding structures is lost.Multiple attempts at improving US guided venous access have been tried, such as oblique visualization or alternating short and long axis views but those approaches still have their shortcomings.

Three dimensional ultrasound (3D US) has a theoretical advantage of increased anatomical awareness, but evidence of improvement in needle based procedures is scarce.

Recently, a new 3D US probe is introduced which can address the above mentioned limitations of 2D US for access procedures.

The investigators hypothesize that this superior three dimensional awareness can improve needle placement during central venous catheterization, increasing success rates and potentially decreasing complications.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

盲法说明

coded (e)crf's and anonymized and coded ultrasound clips

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • elective cardiothoracic surgery with need for central venous catheter placement
  • written informed consent

排除标准

  • no informed consent
  • other site for central line placement (eg subclavian vein)
  • emergency surgery

结局指标

主要结局

first pass success

时间窗: during procedure/surgery

successful entry in internal jugular vein within one skin break and fluid motion

次要结局

  • needling time(during procedure/surgery)
  • number of posterior wall punctures(during procedure/surgery)
  • needle visibility(procedure/surgery)
  • imaging time(during procedure/surgery)
  • number of skin punctures(during procedure/surgery)
  • number of needle withdrawals(during procedure/surgery)
  • operator satisfaction(procedure/surgery)

研究者

发起方
Catharina Ziekenhuis Eindhoven
申办方类型
Other
责任方
Principal Investigator
主要研究者

Harm Scholten

MD

Catharina Ziekenhuis Eindhoven

研究点 (2)

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