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临床试验/NCT00226226
NCT00226226已完成1 期

Peripherally Inserted Central Catheter Placement by IV Team Nurses Using the Sonic Flashlight

University of Pittsburgh1 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2006年6月1日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
230
试验地点
1
主要终点
PICC line successfully placed by intravenous team nurses using the Sonic Flashlight

研究概览

简要总结

The purpose of this study is to test whether peripherally inserted central catheters can be safely placed on patients by intravenous team nurses at the bedside.

详细描述

We have developed a new device for guiding invasive procedures with ultrasound (US), which we call the Sonic Flashlight (SF). We attach a half-silvered mirror and a small flat-panel monitor directly to an ultrasound transducer to project a virtual image of the US scan into its actual location within the patient. This permits the operator to guide a needle through the skin by aiming directly at the image, using natural hand-eye coordination rather than looking away from the patient at a conventional display. We believe the SF will increase accuracy, safety, and speed for a wide variety of invasive procedures and yield a faster learning of these procedures than conventional US displays.

The research proposed here would bring the application of guided needle insertion to its clinical implementation, specifically addressing the placement of the Peripherally Inserted Central Catheter (PICC) line. The PICC line is increasingly viewed as a safe alternative to direct central line placement in the jugular, subclavian, and femoral veins, while being easier to maintain than a peripheral intravenous line. This study will test the hypothesis that PICC lines can be placed by experienced intravenous (IV) team nurses using the SF for real-time US guidance.

Thirty nurse participants (ages 18-65) will be recruited from the IV team at UPMC Presbyterian Hospital to participate in the study. 200 patient subjects will be recruited from the adult (18 years and older) population of patients already scheduled to receive the PICC placement procedure; patients will have the lines placed by experienced IV team nurses using ultrasound guidance with either the SF or conventional ultrasound (CUS). Investigators will observe each procedure, using audio and video recording, ultrasound image data, and other characteristics of the procedure to monitor the success of each procedure. A set of feasibility trials will be conducted in the interventional radiology (IR) suite to assess the level of training the nurses have received prior to the start of the comparison trial.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 or older
  • Undergoing peripherally inserted central catheter placement as standard of care.

排除标准

  • 未提供

结局指标

主要结局

PICC line successfully placed by intravenous team nurses using the Sonic Flashlight

次要结局

  • PICC line successfully placed by intravenous team nurses using conventional ultrasound

研究者

申办方类型
Other

研究点 (1)

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