NCT02747147已完成不适用
Multi-Day Evaluation of the TIVA Device
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- % of Specimen hemolyzed
研究概览
简要总结
Prospective, randomized, single-center study to evaluate the ability of the device to collect good quality blood samples from patients with peripheral IV access over the length of their stay.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient will be admitted to the BWH unit 15 for post-surgical care
- •Patient is at least 18 years old
- •Patient is willing and physically / cognitively able to sign a written consent form
- •Patient is willing and able to complete study questionnaires
- •Patient is NOT a prisoner
排除标准
- •Active hemodialysis
- •Hemolytic disorders (e.g., sickle cell disease)
- •Pregnancy
结局指标
主要结局
% of Specimen hemolyzed
时间窗: up to 4 days
each collected specimen will be analyzed for hemolysis. The hemolysis rate, or % of specimen that are hemolyzed will be reported over all collections.
% Aspiration reliability
时间窗: up to 4 days after PIV placement
blood aspiration with the device is attempted once per day. The % of attempts that are successful will be reported across all attempts
次要结局
- Avg PIV dwell - hours, mean, range(1, 2, 3, and 4 calendar days after PIV placement)
研究者
研究点 (2)
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