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临床试验/NCT03181542
NCT03181542已完成不适用

A Randomized Controlled Study of Efficacy of Infra Red Vein Illumination Versus Standard Technique

Milton S. Hershey Medical Center1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2017年7月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
160
试验地点
1
主要终点
Success Rate

研究概览

简要总结

The objective of the study is to assess the efficacy of the vein visualization device AccuVein (AccuVein, Inc., Huntington, NY) in comparison to a standard technique for establishing intravenous (iv) access in the infant and toddler population (<2years)

详细描述

The objective of this project is to compare the iv success rate using the FDA approved Accuvein device for vein illumination versus not using the device, for infants/toddlers undergoing surgery at Penn State Children's Hospital with an ASA physical status 1, 2, or 3. After obtaining informed consent, the infant will be randomized to the vein illuminatin or standard group based on a computer generated number.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
— 至 2 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Children(<2year) undergoing anesthesia procedures at Penn State Health, Hershey Medical Center and Penn State Children's Hospital
  • •ASA physical status 1,2 or 3

排除标准

  • •Emergency procedures requiring anesthesia
  • •ASA physical status 4
  • •Patients with pre existing iv access

研究组 & 干预措施

Infrared vein illumination

Experimental

Infrared illumination of veins, using the FDA approved AccuVein device, will be used to assist in vein location when inserting an intravenous access line

干预措施: Infrared illumination (Device)

Standard Technique

No Intervention

Standard vein location techniques will be used when inserting an intravenous access line

结局指标

主要结局

Success Rate

时间窗: When patient is in operating room and insertion of intravenous access line has been confirmed to be successful, an average of 30 minutes

Success for insertion of intravenous access line will be determined by flushability with 5 ml of sterile normal saline

次要结局

  • Time to Successful Insertion(When patient is in operating room and insertion of intravenous access line is performed)
  • The Number of Attempts(When patient is in operating room and insertion of intravenous access line is performed)

研究者

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

Priti G. Dalal

Professor of Anesthesiology & Perioperative Medicine

Milton S. Hershey Medical Center

研究点 (1)

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