Responding to the ASRA (American Society of Regional Anesthesia) Challenge - Should Gowning be the Standard of Practice for Epidural Anesthesia: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Growth of microbial organisms on operators forearm, agar plate (working area) and proximal and distal tip of the epidural catheter.
研究概览
简要总结
There is an increasing trend in the incidence of infection related to epidural anesthesia. This could be related to methods of aseptic technique as adopted by the anesthesiologist during the performance of the procedure.
The purpose of this study is to compare two methods of aseptic technique for labor epidural insertion; a "conventional" method without wearing a sterile gown (free from living germs or microorganisms) versus strict aseptic method with wearing of sterile gowns.
It is our belief that there will be an increased contamination of epidural equipment and colonization of epidural catheter, secondary to bacterial fallout from the operators' bare hands in the group not wearing the sterile gowns.
详细描述
At the present time there is no accepted standard for aseptic technique during insertion of an epidural catheter on the labor floor and what is considered to be essential is controversial. Recognizing this, the American Society of Regional Anesthesia (ASRA), the leading authority on regional anesthesia, established a task force to examine and establish guidelines for aseptic practice. Their findings highlighted the lack of good quality studies to support specific recommendations. This is especially true in regards to the use of sterile gowns during the performance of the procedure.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All pregnant women requesting epidural analgesia
排除标准
- •Patients who have fever requiring antibiotics
- •Patients who have received antibiotics in or within the previous 48 hours of labor
- •Immuno-compromised patients.
结局指标
主要结局
Growth of microbial organisms on operators forearm, agar plate (working area) and proximal and distal tip of the epidural catheter.
时间窗: one and one half year
次要结局
- length of epidural catheterization and positive culture(one year and a half)
研究者
Dr. Naveed Siddiqui
Principal Investigator
Samuel Lunenfeld Research Institute, Mount Sinai Hospital