The Influence of Nursing Technique Applied at the Central Venous Catheter Insertion Site Upon the Incidence of Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 221
- 试验地点
- 2
- 主要终点
- Local signs of inflammation
研究概览
简要总结
Assessing the impact of the nursing technique applied at the insertion site of the central venous catheter using hydrophilic methacrylate gel (HMG) and 2% Chlorhexidine (CHG) upon the incidence of inflammatory complications when treating the surrounding of the central venous catheter.
详细描述
The study was a prospective and randomized clinical trial. The study was performed at two departments of the University Hospital Ostrava.
The design and performance of the study were approved by the Ethics Committee of the University Hospital Ostrava.
The patients indicated for insertion of central venous catheter (CVC) were informed about the possible nursing techniques applied at the insertion site of the central venous catheter, participation in the study was conditioned with signing a written informed consent. The study evaluated the superiority of a new procedure in providing nursing care for patients with CVC.
Basic patient characteristics were observed and recorded according to the protocol of the study (age, sex, diagnosis), the number of days with CVC inserted, type of dressing, APACHE II score, the presence of neutropenia and the final score of assessment of local signs of inflammation, which was defined as follows:
0 points = No reddening
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
The study was designed as open-label, no masking was used in the protocol.
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 over 18 years
- •Patients with CVC
- •Hospitalization at ICU
排除标准
- •Allergy to HMG
- •Allergy to transparent foil
- •CVC insertion shorter than 3 days
- •Strong bleeding from CVC insertion site
研究组 & 干预措施
Neutropenia patients
Patients with neutropenia were treated using the CHG and HMG technique.
干预措施: CHG technique (Procedure)
Neutropenia patients
Patients with neutropenia were treated using the CHG and HMG technique.
干预措施: HMG technique (Procedure)
No neutropenia patients
Patients with no neutropenia were treated using the CHG and HMG technique.
干预措施: CHG technique (Procedure)
No neutropenia patients
Patients with no neutropenia were treated using the CHG and HMG technique.
干预措施: HMG technique (Procedure)
结局指标
主要结局
Local signs of inflammation
时间窗: 3 days at minimum, up to 15 days
The local signs of inflammation were observed in both study arms and both interventions, and were assessed according to the scoring system described in detail description.
次要结局
未报告次要终点