Validate the Acceptability of Egret's Extended Use Product as Compared to the Existing Daily Change-out Product
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Measure total aerobic bioburden levels after patient use
研究概览
简要总结
PURPOSE OF EVALUATION: This study will verify & validate the acceptability of Egret's extended use product as compared to the existing daily change-out product. Based on an extensive in-vitro study, Egret's product confirmed significant kill for both positive and negative gram bacteria. In addition to meeting all of the current product requirements, total aerobic bio-burden on the catheters will be tested at various intervals for up to 10 days of use. The current used product will be used as a control group that is to be changed out daily as per current policy. The control group will be tested for total aerobic bacteria counts on the last day of use.
详细描述
Protocol
Title: Extended Use In-line Endotracheal Suction Catheter w/BIOSAFE
Protocol Number: RT 2008-001
Study Director: Richard C. Dowdy
Study Director's Address and Method of Contact:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
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
- •Patients who agree to consent.
排除标准
- •Patients who do not agree to consent or with confirmed Ventilator-associated Pneumonia (VAP)are to be excluded from this study.
结局指标
主要结局
Measure total aerobic bioburden levels after patient use
时间窗: 1 to 10 days
Compare the average aerobic bio-burden level on the extended use Egret catheter to the existing used one day product after clinical use. The Egret catheter was used continuously for up to 10 days.
次要结局
- Design Ease of Use(1-10 days)
- No unexpected adverse events(1-10 days)