Comparison of Success Rates of Femoral Artery Catheterization for Newborns With In-plane and Out-of-plane Ultrasonography Techniques
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Femoral artery catheterization puncture duration
研究概览
简要总结
The use of USI has eased practical application of interventional procedures, and reduced complications and procedure durations. For vascular interventions with ultrasound imaging, short- or long-section imaging of vascular structures is performed. Both techniques have their own advantages and disadvantages.
This study aims to compare the success rates of femoral artery catheterization using both imaging techniques.
详细描述
The research will include newborns undergoing open heart surgery and patients requiring arterial monitoring in the neonatal intensive care unit. Eighty patients requiring femoral artery cannulation will be randomized with the closed envelope method and separated into two groups as USI with the in-plane technique (Group A) and USI with the out-of-plane technique (Group B). The intervention will be performed by a single experienced individual. The preparation duration, puncture duration, number of punctures, number of unsuccessful arterial punctures, development of hematoma and other complications will be recorded and the groups will be compared. If there are 3 unsuccessful attempts the procedure will be ended.1. Patients undergoing KVC surgery and patients requiring arterial catheterization in the neonatal intensive care unit (cases with pulmonary disease, electrolyte disorders, metabolic disease, or sepsis requiring frequent blood sampling) EXCLUSION CRITERIA FOR STUDY VOLUNTEERS
-
Local infection
-
Coagulopathy CLINICAL END-POINTS (MEASURED VARIABLES)
-
Distance of femoral artery to skin, distance of femoral artery to inguinal ligament, femoral artery diameter, femoral artery and vein location properties 2. Preparation duration, number of punctures, complications developing during the procedure
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing KVC surgery and patients requiring arterial catheterization in the neonatal intensive care unit (cases with pulmonary disease, electrolyte disorders, metabolic disease, or sepsis requiring frequent blood sampling
排除标准
- •Local infection
- •Coagulopathy
研究组 & 干预措施
USG with the in-plane technique
Intervention: Femoral artery catheterization under USG guidance with the in-plane technique.Patients will have their femoral arterial lines inserted under the guidance of USG. The ultrasound equipment used is LOGIQ e GE medical system(China) CO.LTD
干预措施: Femoral artery catheterization (Procedure)
USG with the out-of-plane technique
Intervention: Under USG guidance femoral artery catheterization will be done with the probe placed for the out-of-plane technique. The ultrasound equipment used is LOGIQ e GE medical system(China) CO.LTD
干预措施: Femoral artery catheterization (Procedure)
结局指标
主要结局
Femoral artery catheterization puncture duration
时间窗: 1 - 5 minutes
次要结局
- Number of Attempts(5 minutes)
- Rate of Success of First Attempt(1 - 5 minutes)
- Distance of femoral artery to skin(1 - 5 minutes)
- Distance of femoral artery to inguinal ligament(1 - 5 minutes)
- Femoral artery diameter(1 - 5 minutes)
- Complications developing during the procedure(24 hour)
研究者
Ömer Faruk Boran
Assistant Professor
Kahramanmaras Sutcu Imam University