An Investigation of Novel Technology to Bring Genomic Analysis to the Patient Bedside to Systematically Track and Report on ESKAPE Bacterial Transmission in Today's Operating Room Environments
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Intraoperative clonal transmission of Staph aureus.
研究概览
简要总结
Healthcare-associated infections occur frequently and are associated with patient harm. These infections are becoming more difficult to treat due to antibiotic resistance. It is important that healthcare facilities take the steps necessary to prevent the spread of resistant bacteria between patients.
详细描述
Two patients undergoing sedation in a randomly selected operating room will be evaluated in a serial manner in order to detect transmission of pathogenic bacteria. Patient care will not change due to their participation in this study; the patients will undergo sedation and surgery according to usual practice. This study involves taking microbiology cultures from various places in the operating room before and after each procedure. Cultures will also be taken from the two patients after they are asleep and from their intravenous tubing. From both patients anesthesiologist, surgeon and their surgical team, cRNA, and nursing staff will also have cultures obtained. Each cultures will be de-identified and given a study ID number before transport to the research laboratory for microbiological assay. The patient's medical record will be reviewed for 30 days after surgery to surveil for documentation of a potential hospital acquired infection.
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
- 18 Years 至 105 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 18 years of age
- •Require peripheral intravenous and/or central venous catheter placement
- •Undergoing gynecology/oncology, colorectal, open vascular, total joint or cardiovascular procedures.
排除标准
- •Less than 18 years of age
- •Does not require peripheral intravenous and/or central venous catheter placement
- •Patient refusal to participate
- •Incarceration
结局指标
主要结局
Intraoperative clonal transmission of Staph aureus.
时间窗: Intraoperative period
Monitor locations throughout the operating room to document clonal transmission from the area of origin.
Identify transmission dynamics of pathogenic bacteria (i.e. Staph aureus).
时间窗: Intraoperative period
Focus on how Staph aureus is transmitted in the operating room by identifying key areas of origin.
Identify the modes of transmission of pathogenic bacteria ((i.e. Staph aureus).
时间窗: Intraoperative period
If transmission of Staph aureus from the site of origin to another site in the operating room arena is documented, identify the modes of transmission.
次要结局
- Monitor for post operative healthcare associated infections.(Up to 30 days following surgery)
- Surveil for molecular links between pathogenic organisms.(Up to 30 days following surgery)
研究者
Sundara Reddy
Clinical Associate Professor
University of Iowa