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临床试验/CTRI/2024/04/065155
CTRI/2024/04/065155已完成不适用

Comparison of pen holding technique with conventional needle holding technique for ultrasound guided internal jugular venous cannulation in ICU patients.

Government of Haryana _ Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2024年4月15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
132
试验地点
1
主要终点
To compare time taken for successful guidewire insertion.

研究概览

简要总结

Title :Comparison of pen holding technique with conventional needle holding technique for ultrasound guided internal jugular venous cannulation in ICU patients.

Aim :To compare proximal pen-holding technique with conventional technique to cannulate right internal jugular vein under ultrasound guidance. Primary Objective:

  1. To compare time taken for successful guidewire insertion Secondary objectives: 1. To compare number of attempts to localize the vein. 2. To compare ease of procedure. 3. To compare incidence of posterior vessel wall puncture.

4.     To compare incidence of any other complications.

Inclusion criteria: Adult patients aged between 18-60 years, of either sex requiring central venous cannulation admitted in intensive care unit. Exclusion criteria: Patients with Bleeding tendency, Cervical spine disorders, Neck surgery/pathology, Burns patients. Patients on high doses of inotropes/vasopressors, Pregnant females and Unwilling to participate will be excluded. Sample Size: 132 (66 in each arm) Group allocation Patients will be allocated into one of the following groups using computer generated randomization table. Group P (n=66) will be cannulated with proximal pen holding technique. Group C (n=66) will be cannulated with conventional needle holding technique.

Assessment : 1)Time taken for successful guidewire placement in seconds, Number of attempts required to localize the vein,Number of redirections in each attempt, Ease of the procedure, Incidence of  PVWP, Any other complications ,Adverse events and Failure Analysis : Data will be compiled, compared and appropriate statistical test will be applied to analyse the results.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Adult patients aged between 18-60 years, of either sex requiring central venous cannulation admitted in intensive care unit.

排除标准

  • Patients with Bleeding tendency, Cervical spine disorders, Neck surgery/pathology, Burns patients, Patients on high doses of inotropes/vasopressors, Pregnant females and patients unwilling to participate will be excluded.

结局指标

主要结局

To compare time taken for successful guidewire insertion.

时间窗: T1 - At successful placement of guidewire in IJV

次要结局

  • To compare number of attempts to localize the vein.
  • To compare ease of procedure.(T2 - At successful placement of CVP catheter in IJV)
  • To compare incidence of posterior vessel wall puncture(T1 - At successful placement of guidewire in IJV)
  • To compare incidence of any other complications(T2 - At successful placement of CVP catheter in IJV)

研究者

发起方
Government of Haryana _ Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Tarun Yadav

Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences Rohtak

研究点 (1)

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