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临床试验/NCT05656937
NCT05656937已完成不适用

Oblique Versus Transverse Transducer Orientation Approach for Ultrasound Guided Internal Jugular Venous Cannulation in Heart Surgery Pediatric Patients

Indonesia University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
% of patients with successful cannulation in first attempt

研究概览

简要总结

this study aimed to compare oblique versus transverse orientation approach in jugular venous cannulation in term of cannulation success in pediatric heart surgery patients

详细描述

Sixty patients randomised into two groups, 30 patients in experimental group (oblique orientation) and 30 patients in control group (transverse orientation). All cannulation took place in the operation room. Patients underwent general anesthesia and placed in supine position. Standard monitoring (electrocardiogram, non-invasive arterial pressure, pulseoxymetry) was carried out during the procedure for all patients. Before preparation of the skin, a pre-procedure ultrasound examination was performed to verify internal jugular vein patency, and its diameter was measured. Once the side had been chosen, the cannulation was performed following a sterile technique. All procedure were performed by Seldinger technique, with 22 Gauge IV catheter attached with 3 ml syringe as introducer needle. The vascular puncture was performed under ultrasound guidance, using a single-person technique. With transverse orientation, the transducer was placed transversally over the neck, and once the vein was visible in the middle of the ultrasound image, the needle was inserted in the plane perpendicular to the long axis of the transducer. With oblique orientation, the operator first obtained a transverse view of the vein and then rotated the transducer to 45 degrees (midway) between transverse and longitudinal view.

研究设计

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

入排标准

年龄范围
3 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • patients age 3 months to 12 years old, weight 5-20 kg, male or female
  • who undergo heart surgery and indicated to have central venous cannulation
  • American Society of Anesthesiologist Physical Class 1-3
  • Family or representation of the patients agreed to participate in this study and sign informed consent

排除标准

  • history of surgery in the area of cannulation
  • already placed central venous cannulation <72 hours in the same venous
  • sign of infection, hematoma, emphysema, in the area of cannulation
  • history of cervical trauma
  • severe hemostatic disorder (International Normalized Ratio>2, thrombocyte <50.000, Prothrombin time>1.5 times, Activated Partial Thromboplastin Time > 1.5 times

结局指标

主要结局

% of patients with successful cannulation in first attempt

时间窗: at the procedure of cannulation

The number of patients undergo cannulation with first attempt success are shown in percentage

次要结局

  • % of patients with successful cannulation with designed approach(at the procedure of cannulation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aldy Heriwardito

Principal Investigator

Indonesia University

研究点 (2)

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