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临床试验/NCT01637987
NCT01637987终止不适用

Nurse Peripheral Intravenous Catheter Insertion Success With and Without Assistive Devices in Patients 0-12 Months of Age

University of Nebraska2 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2012年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
104
试验地点
2
主要终点
Successful PIV insertion during first or second cannulation attempt.

研究概览

简要总结

The purpose of this study is to determine if the use of a vein identification assistive device increases nurse PIV insertion success within the first two attempts in children 0-12 months of age when compared to unassisted methods.

详细描述

Obtaining peripheral intravenous (PIV) access is a nearly universal procedure for medical management of the hospitalized pediatric patient. In children, PIV placement can often be difficult due to the inability to identify peripheral veins (Wilson, 2007). Many assistive devices have been used or promoted to improve vein visualization with the intention of increasing PIV insertion success. Limited research was found to support this assumption regarding nursing PIV insertion success in children. This study is a randomized, controlled trial to determine if the use of a vein identification assistive device increases nurse PIV insertion success within the first two attempts in children 0-12 months of age when compared to unassisted methods. Patients admitted to Children's Hospital & Medical Center (CHMC) Emergency Department, 4th floor medical-surgical unit, or 5th floor medical-surgical/ Intermediate Care Unit, up to 12 months of age requiring non-emergent PIV placement as part of their medical plan of care will be eligible. Following consent subjects will be randomized into one of three vein identification method study groups (1) Wee Sight Transilluminator - a hand held light emitting device held adjacent to or under the patient's extremity to visualize the venous anatomy; (2) VeinViewer - uses near infrared light to view hemoglobin and projects an image of venous anatomy onto the skin; and (3) Unassisted Methods - traditional techniques of vein visualization and palpation. Based on study group assignment the nurse will use the appropriate vein identification method during the first two PIV insertion attempts. Evaluation of vein identification methods will be based on PIV insertion success or failure.

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
None

入排标准

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

入选标准

  • Admitted to Children's Hospital & Medical Center Emergency Department, 4th floor medical-surgical unit, or 5th floor medical-surgical/Intermediate Care Unit
  • Require non-emergent PIV placement as part of medical plan of care
  • Less than or equal to 12 month birth date

排除标准

  • Greater than 12 month birth date
  • PIV not required
  • PIV inserted by practitioner other than RN
  • PIV inserted by RN not employed by study areas
  • Ward of state
  • Require emergent PIV placement
  • Primary language is not English or Spanish

结局指标

主要结局

Successful PIV insertion during first or second cannulation attempt.

时间窗: Immediate upon completing first or second PIV insertion attempt

Success = Insertion of a 22 or 24-gauge catheter into a peripheral vein followed by the immediate ability to flush 1-2 ml normal saline without signs of venous infiltration (e.g., pain and swelling). Failure = Inability to insert a 22 or 24-gauge catheter into a peripheral vein, or insertion of a catheter into a peripheral vein followed by the immediate inability to flush 1-2 ml normal saline or signs of infiltration upon flushing.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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