Comparison Between the Long (Mini-midline) and the Short Catheter (Peripheral Intravenous Catheter) in the Reduction of Venipunctures During Hospital Stay: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 294
- 试验地点
- 2
- 主要终点
- Difference in proportion
研究概览
简要总结
The goal of this randomized controlled trial is to investigate the difference between LPC (mini-midline) and PIVC (peripheral venous catheter) on the need of further venipuncture for blood withdrawal or placement of a new vascular access.
The main questions it aims to answer are:
- Whether the number of patients with LPC and PIVC differ in terms of repeated venipunctures;
- Whether the number of patients with LPC and PIVC differ in terms of adverse events associated with the use of such vascular catheters.
Researchers will compare the proportion of patients with repeated venipunctures between LPC and PIVC arms.
详细描述
A standard peripheral intravenous catheter (PIVC) or a mini-midline (LPC) will be placed according to routine clinical indications (i.e., for blood withdrawal and IV drug therapy) in patients seeking care at the Emergency Department. On admission at the Emergency Department triage desk, patients will be assigned a triage code according to clinical assessment by the triage nurse and will be evaluated as to the probability of being eventually admitted to hospital. Following enrollment, patients will be randomly assigned to receive LPC or PIVC. The follow-up period begins after catheter placement and continues through transfer to a hospital ward. During this period of catheter management, the insertion site and dressing will be monitored.
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
- Single (Outcomes Assessor)
盲法说明
The statistician will be provided an anonymized dataset.
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
- •Age ≥ 18 years
- •High probability of hospital admission
- •Sufficient venous patrimony according to EA-DIVA scale score
排除标准
- •Patients already having a venous access in place
- •Patients requiring life-saving treatments
- •Patients seeking ambulatory care
- •Patients unable to express informed consent
结局指标
主要结局
Difference in proportion
时间窗: The catheter will be evaluated within 24 hours after the placement
Difference between the two study arms in the proportion of patients who required a venipuncture after insertion of the PIVC or the LPC.
次要结局
- Adverse events associated with use of LPC and PIVC(Adverse will be evaluated every 24 hours till the catheter removal)
研究者
Alessandro Galazzi
Principal investigator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico