Evaluation of Performance Over Dwell Time and Safety of the Central-venous Catheters Certofix® Paed
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Late complications
研究概览
简要总结
Central venous catheterisation is a medical technique that has become established over many decades and can be rated as State of the Art. However, there is only few clinical evidence for the use of Certofix® Paed and additional clinical data need to be collected to underline the long-term performance and safety in paediatric patients. An updated summary overview of Binninger and Roschke describes the potential incidence rates of the classically catheter-related complications, e.g. catheter malposition, catheter fracture, occlusion, thrombosis and catheter-related bloodstream infections (CRBSI) which may have an impact on overall morbidity, mortality and treatment costs. These catheter-related complications should be evaluated in this non-interventional study in paediatric patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed assent from patients as well as written informed consent from legal representatives / parents (as applicable)
- •Patient's first catheter placement during current hospital stay
- •Placement of catheter according to IFU (Instruction for Use)
排除标准
- •Contraindications according to IFU
- •Patient has a documented or known allergy/sensitivity to a medical adhesive product such as transparent film, adhesive dressing, tapes or liquid skin protectants
- •Inclusion in another interventional study in the field of central-venous catheters which could interfere with the routine clinical practice regarding the application and care of the product until removal
结局指标
主要结局
Late complications
时间窗: up to 30 days
Incidence of malpositioning of catheter due to dislodgement or migration
次要结局
- Early complications of central venous catheter application(Up to 2 hours)
- Catheter handling details(up to 30 days)
- Catheter variables(up to 30 days)
- Reason for removal of catheter(up to 30 days)
- Incidence of systemic infection(up to 30 days)
- Serious Adverse Event (SAE)(up to 30 days)
- Serious Adverse Device Effect (SADE)(up to 30 days)
- Concomitant medication(up to 30 days)
- Adverse Device Effect (ADE)(up to 30 days)
- Device Deficiency (DD)(up to 30 days)
- Demographic data(Prior study start)