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
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 175
- 试验地点
- 6
- 主要终点
- IV Insertion Success Rate at First Attempt IV Insertion Success Rate at First Attempt
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
IV Insertion Success Rate at First Attempt IV Insertion Success Rate at First Attempt
时间窗: 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.
Summary of Major Complications
时间窗: 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.
次要结局
- Time Required to Obtain Access(An access attempt usually ranges from 0 to 45 minutes in duration.)
- Second Stick Success Rate(An access attempt usually ranges from 0 to 45 minutes in duration.)
- Summary of Minor Complications(Post-PIV placement until catheter removal (usually within 4 days))