The AccuCath Intravenous Catheter System With Retractable Coiled Tip Guidewire and Conventional Peripheral Intravenous Catheters: A Prospective, Randomized, Controlled Comparison by General Hospital Nursing Staff
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 248
- 试验地点
- 2
- 主要终点
- First Attempt Success Rate With Peripheral IV Catheter Placement
研究概览
简要总结
The study will test a hypothesis that the AccuCath™ System will have a higher rate of successful first attempt peripheral intravenous (IV) placement, higher completion of therapy, fewer complications, longer dwell times, and higher user satisfaction compared to conventional IV catheters.
详细描述
This study is designed to evaluate user/physician preference as it relates to use of a 510(k) cleared vascular access and catheter device compared with conventional needle/catheter vascular access devices, in terms of first stick success rates, dwell time, device-related vascular complications and adverse events and overall user and patient satisfaction. As noted above, the study is designed to formally test the hypothesis that the AccuCath™ System will exhibit superiority in terms of the rate of successful first attempt peripheral IV placement, higher completion of therapy, fewer complications, longer dwell times and higher user satisfaction compared to conventional intravenous catheters.
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 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age ≥ 18 years or ≤ 89 years old;
- •Capable and willing to give informed consent;
- •English speaking;
- •Acceptable candidate for an elective, non-emergent peripheral intravenous (PIV) catheter placement as determined by ordering physician;
- •Admitted to study inpatient unit.
排除标准
- •Male or female, < 18 years old or > 89 years old;
- •Requirement for emergent IV placement (patient's condition would be compromised if there is a delay in IV placement);
- •Previous venous grafts or surgery at the target vessel access site;
- •Currently involved in other investigational clinical trials (unless permission is granted by other study principal investigator [PI]);
- •Females who are pregnant, planning to become pregnant within 3 months of the procedure, or lactating.
结局指标
主要结局
First Attempt Success Rate With Peripheral IV Catheter Placement
时间窗: At catheter placement, an expected average of 10 minutes
The primary outcomes measure is to observe first attempt success rate in patients requiring peripheral IV access by documenting the number of catheter attempts (each new catheter) required to complete successful peripheral IV placement.
次要结局
- Completion of IV Therapy(Study exit/At catheter removal (~ up to 7 days))
- Complications of Peripheral IV Therapy(From during to post IV catheter placement up to study exit (~ up to 7 days))
- Catheter Dwell Time(Study Exit/At catheter removal (~ up to 7 days))
- Patient Satisfaction At Insertion(At catheter insertion, initial 3-15 minutes after insertion procedure completed.)
- Clinician Satisfaction(At completion of study after all patients have been enrolled (approximately 6 months from study initiation))
- Adverse Events(During and post IV catheter placement until study exit (maximum of 6 months).)
- Patient Satisfaction Comfort Comparison(Immediately after catheter insertion, within the first 3-15 minutes of insertion procedure.)
- Patient Satisfaction With Overall IV Performance(At IV removal (usually after 1-7 days of IV dwell time))