Short-axis/out-of-plane Approach Versus Oblique- Axis Approach for Ultrasound-guided Internal Jugular Venous Catheterization in Infants.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Difference in the rate of acute complications between the two groups.
研究概览
简要总结
The investigators will measure and compare the rate of acute complications, success rate, number of attempts to successful cannulation between ultrasound-guided short axis approach and oblique axis approach during internal jugular venous catheterization in infants.
详细描述
- pre-procedure settings: The history will be obtained from patient's parents. Investigations will be checked to all patients as (complete blood picture and coagulation profile) to avoid coagulopathy and thrombocytopenia.
All patients will be attached to standard monitoring (blood pressure (non-invasive), heart rate, and pulse oximetry).
Groups:
Patients will be assigned randomly by using a computer -generated table of random numbers into two groups:
- Group A (control group): ( n=25 ): CVL insertion in the right internal jugular vein using ultrasound. The US probe is placed perpendicular to the venous anatomy in the SAX approach.
- Group B (comparative group): ( n=25 ): CVL insertion in the right internal jugular vein using ultrasound. The US probe is aligned at 45° angulation?clockwise with the venous anatomy in the OAX approach.
- procedure Settings: Monitor will be connected and pulse oximetry (SPO2), baseline non-invasive blood pressure (NIBP), heartrate (HR), electrocardiogram (ECG) will be obtained.
In this study, we will use US machine with small linear probe with frequency 5 - 10 Hz and the procedure will be held by the most senior Anaesthesiologist experience in pediatric central venous catheterization for at least 3 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Month 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 1 month and 12 months
- •Physical status: patients requiring CVC in their management
排除标准
- •patient's parents refuse to do the study
- •Coagulopathy (INR > 1.5, platelets count < 50.000), use of anti-coagulant or anti platelet therapy) (Sunny et al, 2022)
- •Infection, wounds or subcutaneous hematoma close to the puncture site
- •history of previous surgical intervention at the cannulation site
- •subcutaneous emphysema, penetrating neck trauma or cervical trauma
结局指标
主要结局
Difference in the rate of acute complications between the two groups.
时间窗: Post-procedure, through study completion (average 1 year)
acute complications as posterior venous wall puncture (PVWP) (ultrasonographic identification of the needle tip or guidewire at any site deeper than the posterior wall of the IJV during cannulation attempts), skin and subcutaneous hematoma, arterial puncture (any pulsatile blood reflux through the needle observed during the procedure), pneumothorax, hemothorax and catheter misplacement (catheter tip identified at any place other than the superior vena cava in the control chest radiograph)
次要结局
- unsuccessful cannulation.(Post procedure, through study completion (average 1 year))
- Difference in the rate of first successful cannulation attempt.(Post procedure, through study completion (average 1 year))
- the number of needle redirection.(Post procedure, through study completion (average 1 year))
- the flash time.(Post procedure, through study completion (average 1 year))