A Post-market, Randomized Study Evaluating the Clinical Performance of the ViaValve™ Safety IV Catheter
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Frequency of blood leakage
研究概览
简要总结
The objective of this post-market, prospective study is to evaluate the clinical acceptability, blood leakage, risk for blood exposure, need for digital compression, insertion success, and clinical utility of the ViaValve™ Safety IV Catheter compared to standard hospital PIVCs currently being used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 否
入选标准
- •A peripheral intravenous catheter will need to be inserted in order to gain access to a vein or artery to sample blood, monitor blood pressure, or administer fluids intravenous infusion as part of treatment.
- •Willing and able to sign an Informed Consent (patient or legally authorized representative).
排除标准
- •Body morphology (e.g., size) precludes the use of a peripheral intravenous catheter.
- •Fluid to be infused is not appropriate for peripheral intravenous catheters.
结局指标
主要结局
Frequency of blood leakage
时间窗: Clinicians will report if blood leakage occurred immediately after the catheter insertion
Demonstrate superiority of the ViaValve™ Safety I.V. Catheter compared to the control in preventing blood leakage from the catheter hub during insertion.
Eliminating risk of blood exposure
时间窗: Clinicians will report on the ability of the PIVC to eliminate blood exposure immediately after catheter insertion
Demonstrate superiority of the ViaValve™ Safety I.V. Catheter compared to the control PIVC in eliminating the clinician's risk of blood exposure during the insertion process.
Clinical acceptability of PIVC insertion
时间窗: Clinicians will provide the rating immediately after performing the insertion
Demonstrate non-inferiority of the ViaValve™ Safety I.V. Catheter compared to the control PIVC for ratings of clinical acceptability. Clinicians will agree or disagree that the device was clinically acceptable for the insertion.
次要结局
- Insertion success(Clinicians will report if the insertion was successful immediately after performing insertion)
- Elimination of digital compression(Clinicians will provide the rating immediately after performing the insertion)
- Ease of Use(Clinicians will provide the rating immediately after performing the insertion)