Effectiveness of a Needle-free Connector With Anti-reflux Technology in Reducing Complications From Long Peripheral Venous Catheters in Hospitalised Adult Patients: Randomised Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 62
- 主要终点
- Number of participants who experienced device-related adverse events, classified according to CTCAE v5.0.
研究概览
简要总结
A study to evaluate a needle-free connector (a stopper) featuring anti-reflux technology (to prevent blood from flowing back) for catheters (polyurethane tubes inserted into a vein), with the aim of reducing complications associated with these devices: blockages, infections, pain, etc.
详细描述
Introduction: Long peripheral venous catheters (PVCs) are a suitable alternative to short PVCs, midline catheters (MLCs) and central venous catheters (CVCs), particularly in patients with difficult intravenous access (DIVA), due to their characteristics: they are between 6 and 15 centimetres in length, have a gauge of 18 to 22 gauge (G), and do not extend beyond the axillary vein.
Hypothesis: The use of a needle-free connector with neutral fluid displacement and equipped with anti-reflux technology (Clave™ Neutron™) in long PVCs in adult inpatients with acute conditions reduces the number of catheter failures during the first seven days compared with a neutral-displacement needle-free connector without an anti-reflux valve.
Objective: To evaluate the efficacy of using a needle-free connector with neutral fluid displacement and equipped with anti-reflux technology (Clave™ Neutron™) following the insertion of long PVCs in adult inpatients in the acute phase of their illness during the first seven days.
Methodology: A clinical study involving two randomised groups will be conducted prior to catheter placement. The control group will receive treatment using a needle-free connector with neutral fluid displacement and without an anti-reflux valve (Microclave® Clear, Ref. 011-MC3302). The intervention group will receive treatment using a needle-free connector with neutral fluid displacement and equipped with anti-reflux technology (Clave™ Neutron™, Ref. 011-NC139).
Expected results: It is expected that the incidence of complications associated with long PVCs in hospitalised adult patients will be reduced following the standardised implementation of a needle-free connector with neutral fluid displacement and equipped with anti-reflux technology (Clave™ Neutron™) during the initial phase of treatment. Specifically, a reduction in the incidence of catheter obstructions and CRBSI is anticipated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Researchers will be responsible for catheter insertion and subsequent data collection; however, patients will be blinded to the type of needle-free connector used (with or without anti-reflux technology). In addition, the results will be evaluated by an independent researcher who is not involved in the data collection process.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients requiring placement of a long peripheral venous catheter.
- •Patients who have provided written informed consent.
- •Patients with an expected hospital stay of ≥7 days.
排除标准
- •- Inability to place a long peripheral venous catheter in the upper limbs.
研究组 & 干预措施
Needle-free connector without anti-reflux technology
Insertion of a long peripheral venous catheters (PVCs) using the accelerated Seldinger technique (AST), followed by placement of a needle-free connector with neutral fluid displacement and no anti-reflux technology (Microclave® Clear, Ref. 011-MC3302).
干预措施: Needle-free connector with neutral fluid displacement and without anti-reflux technology (Procedure)
Needle-free connector without anti-reflux technology
Insertion of a long peripheral venous catheters (PVCs) using the accelerated Seldinger technique (AST), followed by placement of a needle-free connector with neutral fluid displacement and no anti-reflux technology (Microclave® Clear, Ref. 011-MC3302).
干预措施: Long peripheral venous catheter (Device)
Needle-free connector without anti-reflux technology
Insertion of a long peripheral venous catheters (PVCs) using the accelerated Seldinger technique (AST), followed by placement of a needle-free connector with neutral fluid displacement and no anti-reflux technology (Microclave® Clear, Ref. 011-MC3302).
干预措施: Ultrasound scanner (Other)
Needle-free connector with anti-reflux technology
Insertion of a long PVCs using the AST, followed by placement of a needle-free connector featuring neutral fluid displacement and anti-reflux technology (Clave™ Neutron™, Ref. 011-NC139).
干预措施: Needle-free connector with neutral fluid displacement and equipped with anti-reflux technology (Procedure)
Needle-free connector with anti-reflux technology
Insertion of a long PVCs using the AST, followed by placement of a needle-free connector featuring neutral fluid displacement and anti-reflux technology (Clave™ Neutron™, Ref. 011-NC139).
干预措施: Long peripheral venous catheter (Device)
Needle-free connector with anti-reflux technology
Insertion of a long PVCs using the AST, followed by placement of a needle-free connector featuring neutral fluid displacement and anti-reflux technology (Clave™ Neutron™, Ref. 011-NC139).
干预措施: Ultrasound scanner (Other)
结局指标
主要结局
Number of participants who experienced device-related adverse events, classified according to CTCAE v5.0.
时间窗: 7 days
Percentage of participants experiencing adverse events following insertion of a long peripheral venous catheter and placement of a needle-free connector featuring neutral fluid displacement and anti-reflux technology (Clave™ Neutron™, Ref. 011-NC139).
次要结局
- Number of participants with partial or complete occlusions in long peripheral venous catheters, as assessed using the CINAS scale (UZ Leuven®).(7 days)
研究者
Ferran Padilla Nula
Nurse
Hospital Arnau de Vilanova