NCT04048863终止不适用
Assessment of the Effect of B. Braun Peripheral Advantage Program on Complications, Indwell Time and First Stick Success of PIVC Therapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Complications Associated With PIVC Use
研究概览
简要总结
Single sequence clinical study designed to evaluate the effectiveness of B. Braun PA on improved clinical outcomes, indwell time and first stick success of PIVC using B. Braun Peripheral Advantage (PA) by Registered Nurses (RNs).
The study will be conducted in the Emergency Department (ED) and/or Medical Surgical (MS) floor(s)/unit(s) in multiple hospitals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •RNs must complete all of the required B. Braun trainings in Stage 2 in order to participate in Stages 3 and
- •Subjects must meet all of the following Inclusion Criteria:
- •Male or female aged ≥18 years;
- •The subject or the subject's LAR voluntarily agrees that the subject will participate in this study and is able to understand and sign the Informed Consent Form (ICF);
- •Have a medical condition that requires a PIVC anticipated to last for at least 48 hours;
- •Have intact skin at the site of insertion;
- •If the patient has an existing IV in one arm he/she must have a viable contralateral arm for additional PIVC insertion.
排除标准
- •Subjects must not meet any of the following Exclusion Criteria:
- •Are currently participating in another medical device or pharmaceutical study;
- •In the opinion of the Investigator, would not be suitable candidates for this study;
- •The subject or his/her LAR is an employee of the Investigator or study center, or the sponsor, or have direct involvement in the study or other studies under the direction of that Investigator or study center, or are a family member of the employees or the Investigator;
- •Have a laboratory confirmed bloodstream infection within 48 hours prior to participation in the study. The assessment is based on clinical observations and not routine for all subjects;
- •Patient has an existing non study related IV;
- •Was removed from any Stage of the study due to an AE associated with the PIVC.
结局指标
主要结局
Complications Associated With PIVC Use
时间窗: Through study completion, an estimate of 1 year
\[Planned\] Outcome: Evaluate the impact of B. Braun Peripheral Advantage (PA) Program on the number of stick attempts with complications associated with PIVC use. Due to the early termination in Stage 1, no data were collected from Stages 2 through 4 to perform comparative analyses.
次要结局
- First Attempt Success Rates (First Stick Success)(Initial needle stick (baseline))
- Catheter Indwell Time(Up to 48 hours and between 48 and 168 hours)
- Aggregate Costs Associated With Catheter Insertion(Through study completion, an estimate of 1 year)
研究者
研究点 (2)
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