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临床试验/NCT01924975
NCT01924975已完成不适用

Ultrasound-image Guided Versus Traditional Landmark Technique for Saphenous Vein Cannulation in Infants and Small Children

Satoshi Hanada2 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2013年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
102
试验地点
2
主要终点
Percentage of Participants With First Attempt Success of Saphenous Vein Cannulation

研究概览

简要总结

The purpose of this study is to compare the two different saphenous vein cannulation techniques; real-time ultrasound image-guided technique (Ultrasound group) vs. traditional landmark technique (Landmark group).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
— 至 4 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Pediatric patient undergoing scheduled surgery which requires venous cannulation.
  • Term neonates and children < 4 years old weighing >/= 3 kg

排除标准

  • Patient with visible saphenous vein
  • Patient with no detectable saphenous vein under ultrasound
  • Patient with a skin wound or infection around puncture site
  • Patient with recent venous puncture at the puncture site (less than 1 month)
  • Patient with thrombus in saphenous vein or hematoma formation around the vein detected by ultrasound.
  • Patient with any emergency surgery

研究组 & 干预措施

Landmark group

Active Comparator

An operator is not allowed to use an ultrasound. A 22 or 24 G catheter will be advanced blindly toward the expected location of the saphenous vein at the level of the medial malleolus. Once blood appears in the hub, then the catheter will be advanced into the saphenous vein.

干预措施: Saphenous vein cannulation (Procedure)

Landmark group

Active Comparator

An operator is not allowed to use an ultrasound. A 22 or 24 G catheter will be advanced blindly toward the expected location of the saphenous vein at the level of the medial malleolus. Once blood appears in the hub, then the catheter will be advanced into the saphenous vein.

干预措施: A 22 or 24 G intravenous catheter (Device)

Ultrasound group

Active Comparator

An operator will identify the saphenous vein by using ultrasound with a linear transducer (L15-7io) in short axis view. A 22 or 24 G catheter will be advanced until the tip of the needle is seen on the ultrasound image. The needle is then advanced until blood appears in the hub. The catheter is then advanced into the saphenous vein.

干预措施: Saphenous vein cannulation (Procedure)

Ultrasound group

Active Comparator

An operator will identify the saphenous vein by using ultrasound with a linear transducer (L15-7io) in short axis view. A 22 or 24 G catheter will be advanced until the tip of the needle is seen on the ultrasound image. The needle is then advanced until blood appears in the hub. The catheter is then advanced into the saphenous vein.

干预措施: ultrasound with a linear transducer (L15-7io) (Device)

Ultrasound group

Active Comparator

An operator will identify the saphenous vein by using ultrasound with a linear transducer (L15-7io) in short axis view. A 22 or 24 G catheter will be advanced until the tip of the needle is seen on the ultrasound image. The needle is then advanced until blood appears in the hub. The catheter is then advanced into the saphenous vein.

干预措施: A 22 or 24 G intravenous catheter (Device)

结局指标

主要结局

Percentage of Participants With First Attempt Success of Saphenous Vein Cannulation

时间窗: 10 minutes

次要结局

  • Percentage of Participants With Success of Saphenous Vein Cannulation Within 3 Attempts of Needle Insertion, or a 10 Minute Time Period.(10 minutes)
  • Time Required for Overall Successful Venous Cannulation.(10 minutes)

研究者

发起方
Satoshi Hanada
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Satoshi Hanada

Clinical Assistant Professor

University of Iowa

研究点 (2)

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