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临床试验/NCT04690296
NCT04690296已完成不适用

Ultrasound Guidance Versus Anatomical Landmarks for Subclavian Vein Catheterization: a Prospective Randomized Study

University Tunis El Manar0 个研究点目标入组 70 人开始时间: 2015年1月5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
70
主要终点
the successful insertion of the catheter.

研究概览

简要总结

This was a prospective randomized study. After prior approval by the Ethics Committee, we included all patients aged over 18 years- old who were admitted to the intensive care unit (ICU) and who required a central venous catheterization (CVC) outside the emergency's context. Non-inclusion criteria were thrombosis of the vein or coagulopathy. All catheterizations were done by the same non-experimented practitioner. Patients were randomized into two groups according to the catheterization's technique of subclavain vein: real-time long axis ultrasound guidance (US group) and anatomical landmarks ( LM group). The main outcome was success. The secondary outcomes were: success' rate at first puncture, number of punctures, rate of redirections, number of redirections, access's time, preparation and spotting time and rate of complications (arterial puncture, hematoma, pneumothorax, wrong position of the catheter).

Data analysis was performed using the SPSS® software version 20: The Student's "t" test was used to compare the normally distributed quantitative variables, the Mann-Whitney's test for non-normally distributed quantitative variables and the Chi-square and Fisher tests for qualitative data. A value of p <0.05 was considered as statistically significant.

详细描述

Methods:

Study population:

It was a prospective randomized study, conducted in the ICU after obtaining approval by the local ethics committee.

We enrolled all patients older than 18 years and requiring a CVC in non emergent conditions after obtaining a written informed consent from the patient or trusted person.

The exclusion criteria were the vein thrombosis and the existence of a coagulopathy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

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

  • Patients admitted in intensive care unit requiring a central venous catheter (CVC)

排除标准

  • • Major blood coagulation disorders,
  • Any thrombotic formations within the vein,
  • Congenital or acquired deformity of neck or clavicle
  • Cannulation site infection, hematoma and surgery

结局指标

主要结局

the successful insertion of the catheter.

时间窗: During the venous cannulation procedure

Failure was defined by a number of attempts greater than or equal to five

次要结局

  • the success's rate in the first attempt(During the venous cannulation procedure)
  • The evolution of the blood reflux time (success) as a function of the rank of the patients in the 02 groups(During the venous cannulation procedure)

研究者

发起方
University Tunis El Manar
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mechaal Benali

Professor

University Tunis El Manar

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