Implementation of an Infusion Management Scheme to Improve Patient Outcome in Tertiary Children's Hospitals：A Multi-center Before-afer Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1,000
- 试验地点
- 9
- 主要终点
- Incidence of CLABSI
研究概览
简要总结
This study is a multi-center before-after trial design. The object is to observe whether the incidence of central line associated blood stream infection(CLABSI) will tend to descend compared with retrospective electronic medical record data after implementation of an infusion management scheme which comes form " Clinical Practice Guideline on Infusion Therapy in Children " .
详细描述
Infusion therapy is an important part in pediatric ward. Most hospitalized children need indwelling vascular access devices to receive infusion therapy. Much attention has been paid to possible serious or fatal complications due to immature immune system, poor communication ability and cognitive disorder in children during catheter placement, use and maintenance. Reducing the complications related to central venous catheter has become the focus of the global health care system. Studies have shown that the technical level of operators is in connection with the incidence of CLABSI, and an intravenous infusion team (IV Team) is the key to preventing CLABSI, which may fundamentally improve the clinical outcomes of pediatric patients. From December 2021 to April 2023, taking Children's Hospital of Fudan University as the leading center, Xiamen Children's Hospital, Anhui Provincial Children's Hospital, Dalian Municipal Women and Children's Medical Group, Tongji Hospital, First Affiliated Hospital of Guangxi Medical University, Qidong Women's and Children's Health, Chengdu Women's and Children's Central Hospital, Hunan Children's Hospital as the cooperation centers. A retrospective review of electronic medical record data will be collected first. The intervention is composed of setting up a pediatric intravenous infusion team; carrying out a quality improvement in collecting and sending suspected CLABSI samples; providing infusion training curriculums to nurses in forms of lectures, group discussions, operation demonstrations, and scenario simulations, holding practice review meeting with them; providing elements to caregivers of educational leaflet, nurse-provided education during patients' infusion therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •The vice president in charge of nursing affairs or the director of nursing department inform the researcher to withdraw from this study with written form and should clear reasons
- •The number of cases for suspected CLABSI sample actually submitted for inspection / The number of cases for suspected CLABSI sample should submitted for inspection<0.9
- •The awareness rate of infusion management scheme in clinical nurses is less than 90% and the qualification rate of the practice examination in clinical nurses is less than90% during inspection
结局指标
主要结局
Incidence of CLABSI
时间窗: During the 6-month implementation
CLABSI diagnostic criteria requires that a central line is in situ at the time of or within 48 hours; children with a central line have fever (over 38℃), chills, hypotension or mental state changes; there is no alternate source of bloodstream infection. Apart from the above three necessary requirements, CLABSI diagnosis could be accompanied by two positive blood cultures drawn from a peripheral vein and a CVAD, two positive blood cultures drawn from different CVADs, one positive blood culture from a CVAD with a planned specific antimicrobial therapy or common skin contamination bacteria cultured (eg. Coagulase-negative Staphylococci, diphtheroids, Bacillus or Micrococcus). Incidence of CLABSI = (case numbers of CLABSI)/(Catheter Days per Month)×1000‰.
次要结局
- Changes of Inspection rate of suspected CLABSI samples(From baseline to the end of the 6-month implementation)
- Incidece of infiltration (of Grade2 or higher) and/or extravasation(During the 6-month implementation)
- Changes of the scores of readiness of internal context(From baseline to the end of the 6-month implementation)