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Effectiveness of the Rapid Intravascular Start (RIVS) System Versus Conventional Catheter

2017年3月2日 更新者：C. R. Bard

Evaluation of the Safety and Effectiveness of the Rapid Intravascular Start (RIVS) System Versus Conventional Catheter for Peripheral Intravenous (PIV) Insertion in Children, Oncology Patients and Elderly: a Controlled Randomized Trial

The study will test a hypothesis that the RIVS system will have a higher rate of successful first PIV placement compared to conventional catheter without a significant increase in complications and time of procedure.

研究概览

地位

终止

条件

干预/治疗

详细说明

The hypothesis to be statistically tested was that the RIVS system will have a higher rate of successful first attempt peripheral intravenous placement success as compared to conventional peripheral intravenous catheters without a significant increase in device related complications and procedure time.

研究类型

介入性

注册 (实际的)

175

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • California
      • Fremont、California、美国、94538
        • Washington Outpatient Surgery Center
    • Florida
      • Jacksonville、Florida、美国、32204
        • St. Vincent's Medical Center
    • Ohio
      • Cleveland、Ohio、美国、44106
        • University Hospital Case Medical Center

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

5年 至 90年 (孩子、成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria

  • Any type of oncology patients undergoing chemotherapy or post-chemotherapy (without a port/cannula), or over 65 years
  • Requires peripheral IV as determined by examining physician
  • Requires the IV when a study nurse or resident is available
  • Able to sign an informed consent

Exclusion Criteria

  • Active systemic or cutaneous infection or inflammation;
  • Pre-existing immunodeficiency disorder and/or chronic use of systemic steroids;
  • Known, significant history of bleeding diathesis, coagulopathy, von Willebrand's disease or current platelet count < 100,000 cells/mm3, baseline International Normalized Ratio (INR) ≥1.8, or fibrinogen level less than 150 mg/dl (if received a fibrinolytic agent within prior 24 hours);
  • Currently involved in any other investigational clinical trials;
  • Previous vascular grafts or surgery at the target vessel access site;
  • Females who are pregnant, planning to become pregnant within 3 months of the procedure, or lactating;
  • Central line available
  • Requirement for immediate IV placement (patient's condition would potentially be compromised if there is a time delay in IV placement)

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：其他
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：RIVS vascular access
设备：RIVS vascular access
Access to peripheral vasculature
有源比较器：Conventional vascular access
设备：Conventional vascular access
Vascular access using conventional venous access device

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
IV Insertion Success Rate at First Attempt IV Insertion Success Rate at First Attempt
大体时间：An access attempt usually ranges from 0 to 45 minutes in duration.
A successful IV insertion includes all of the following: initial vein penetration, which is visualized by a flash back of blood into the access device, deployment of the guidewire, advancement of the catheter into the vein, retraction of needle and guidewire, and flushing of IV. A secured flushed IV will be indicative of a successful PIV placement.
An access attempt usually ranges from 0 to 45 minutes in duration.
Summary of Major Complications
大体时间：Post-PIV placement until catheter removal (usually within 4 days)
Any device-related or procedure-related adverse event that causes clinically consequential symptoms to the patient. These may include access site hematoma, bleeding, infection, nerve injury, vessel laceration, wound dehiscence, allergic reaction, or inflammation, among others.
Post-PIV placement until catheter removal (usually within 4 days)

次要结果测量

结果测量
措施说明
大体时间
Time Required to Obtain Access
大体时间：An access attempt usually ranges from 0 to 45 minutes in duration.
A secured flushed IV will be indicative of a successful PIV placement.
An access attempt usually ranges from 0 to 45 minutes in duration.
Second Stick Success Rate
大体时间：An access attempt usually ranges from 0 to 45 minutes in duration.
A secured flushed IV will be indicative of a successful PIV placement.
An access attempt usually ranges from 0 to 45 minutes in duration.
Summary of Minor Complications
大体时间：Post-PIV placement until catheter removal (usually within 4 days)
Any device-related or procedure-related adverse event that causes clinically inconsequential symptoms to the patient.
Post-PIV placement until catheter removal (usually within 4 days)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

C. R. Bard

调查人员

  • 首席研究员：Jeffrey S Stuart, MD、Washington Outpatient Surgery Center

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2009年6月1日

初级完成 (实际的)

2013年7月1日

研究完成 (实际的)

2013年8月1日

研究注册日期

首次提交

2009年6月1日

首先提交符合 QC 标准的

2009年6月3日

首次发布 (估计)

2009年6月4日

研究记录更新

最后更新发布 (实际的)

2017年4月13日

上次提交的符合 QC 标准的更新

2017年3月2日

最后验证

2017年3月1日

更多信息

与本研究相关的术语

其他研究编号

  • 62009123

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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