A Prospective, Single Center, Randomized, Cross-over Clinical Trial to Assess the Safety and Effectiveness of the Veinplicity Venous Access Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 主要终点
- Rate of successful venous access on the first attempt.
研究概览
简要总结
The purpose of this study was to examine the Veinplicity Device as an adjunctive IV cannulation tool in subjects with a history of difficult to access veins. The Veinplicity Device is intended to improve venous access rates in compromised patients by taking advantage of the increased circulation that results from provoked muscle stimulation. The study collected information about the device, intravenous access, user and patient perceptions for IV access, and any device or procedural complications or other adverse events. Device use was examined with patients in both a prone and upright position.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Subject ≥ 18 years of age
- •Subject with history of failed venous access, venipuncture, or IV cannula placement
- •Subject agreed to required follow-up
- •Subject provided written, informed consent
排除标准
- •Subject currently had compromised skin on either forearm or hand
- •Subject currently on any blood thinning medication other than 81mg of aspirin
- •Subject had been diagnosed with peripheral neuropathy, has had a complex fracture or surgery in the forearm, or has other condition that diminishes sensation in one or both arms, hands or fingers
- •Subject had a demand type pacemaker or defibrillator
- •Subject is female of child-bearing potential and had a positive urine pregnancy test
- •Subject had a history of seizure, convulsions or epilepsy
- •Subject had a known allergy to Epsom salts
- •Subject had any other condition that may affect the ability to complete study requirements
研究组 & 干预措施
stimulation-assisted
All subjects received treatment (stimulation-assisted) with the Veinplicity Device per the Instructions for Use. The subject underwent standard IV cannulation using a 20 gauge cannula into the available vein immediately after completion of device stimulation. Use of a tourniquet was at the discretion of the nurse performing the IV cannulation.
干预措施: Stimulation-assisted venous access (Device)
stimulation-assisted
All subjects received treatment (stimulation-assisted) with the Veinplicity Device per the Instructions for Use. The subject underwent standard IV cannulation using a 20 gauge cannula into the available vein immediately after completion of device stimulation. Use of a tourniquet was at the discretion of the nurse performing the IV cannulation.
干预措施: 20 guage cannula for IV, tourniquet optional (Other)
standard IV cannulation
The subject underwent standard IV cannulation using a 20 gauge cannula into the best available vein. Use of a tourniquet was at the discretion of the nurse performing the IV cannulation.
干预措施: 20 guage cannula for IV, tourniquet optional (Other)
结局指标
主要结局
Rate of successful venous access on the first attempt.
时间窗: 7 days
Rate of adverse events associated with either the treatment or the venous access site.
时间窗: 7 days
次要结局
- User Perception of IV cannulation difficulty,(7 days)
- Subject Preception of IV cannulation pain(7 days)
- Subject Perception of Device stimulation(7 days)
- Time required to achieve successful IV cannula placement(time from initial puncture to successful IV cannulation)
- Number of attempts required to achieve successful IV cannula placement(over a 24 hour period)