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临床试验/CTRI/2022/07/043694
CTRI/2022/07/043694已完成不适用

“Ultrasound- versus landmark-guided subclavian vein catheterization: a prospective observational studyâ€

Dr Sujit Kshirsagar1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年5月7日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
The primary aim is to evaluate the ease of subclavian central venous cannulation in critically ill patients between two techniques.

研究概览

简要总结

The subclavian vein (SCV) is a common siteof percutaneous access for central vein cannulation in intensive care. Thissite offers several advantages, including a lower incidence of thrombosis andcentral venous catheter (CVC)-related sepsis, with better patient comfort andeasier nursing care.1-3 SCV is an alternative to internal jugularvein (IJV) when this is difficult to locate, as in hypovolemic or obesepatients.4,5 SCV cannulation has the advantage of fixed landmarksbut may be associated with potentially severe complications, e.g., pneumothoraxor hemothorax, likely related to limited operator experience.6,7

The role ofultrasonography (USG) for IJV catheterization has been accepted as the standardof care after the recommendations by National Institute for Health and ClinicalExcellence (NICE) in 2002, but the same guidelines stated that there wasinsufficient evidence to support the use of USG for SCV catheterization. A Cochranesystematic review published in 2015 concluded that “two-dimensional USG offerssmall advantages in terms of safety and quality in comparison with ananatomical landmark technique for either subclavian or femoral veincannulationâ€.8 On the other hand, in recent years, several trialshave shown a reduction in complications and an improvement in first-passsuccess when USG were used.9-12

The goals of presentobservational study are to compare, in two groups of adult patients, theeffectiveness and safety of SCV cannulation with USG or landmark-guidedtechnique.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients will be selected from ICU for SCV cannulation after assessment by senior faculty.
  • Critically ill patients from 18 to 65 years of age, of either gender will be selected.
  • Indications for CVC insertion will be following: hemodynamic monitoring, treatments with vasopressors or any drug likely to induce phlebitis, haemodialysis, requirement of multiple drug infusions simultaneously.

排除标准

  • Life-threatening conditions requiring an emergency CVC positioning will be excluded.

结局指标

主要结局

The primary aim is to evaluate the ease of subclavian central venous cannulation in critically ill patients between two techniques.

时间窗: immediately measured time for insertion of central venous line

次要结局

  • to evaluate the number of attempts, cannulation failure, and mechanical complications which if develops(5 minutes after the procedure)

研究者

发起方
Dr Sujit Kshirsagar
申办方类型
Other [self]

研究点 (1)

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