Innovation Against Infection - Device Related Infections - Part ETT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Region Skane
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Structure, thickness, and presence of microbes of biofilm developed on endotracheal tube
研究概览
简要总结
Three endotracheal tubes (ETTs) with different surfaces properties will be studied regarding formation and structure of the biofilm formed on those ETTs.
Cultures from oropharynx and tracheal secretions as well as pieces of the ETT will be examined.
Findings from electron microscopy (EM) and microbiology will be analyzed and compared in respect to the three materials.
详细描述
Ventilator associated pneumonia (VAP) is a frequent and costly complication to mechanical ventilation in critically ill patients. Aspiration of oropharyngeal secretions and fragments of biofilm from the endotracheal tube are the main causes of VAP.
It is well known that biofilm is formed on medical devices and several initiatives to reduce the development of such biofilms have been taken. However it is still a large clinical problem and colleagues have performed studies to find out the structure of the biofilms formed on the ETT and to what extent microbiological findings correlate to images from EM.
In this study the investigators will compare microbiology and EM images in that same manner.
Three different ETTs will be examined. The investigators will be using each of the three ETTs for a period of time sufficient to retrieve samples from at least 20 ETTs of each kind.
Only one kind of ETT will be used during the specified time period, no randomization. The test will be performed in the order mentioned below A - B - C All of the three tubes are CE-marked (Conformité Européenne) and are available on the market.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
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 needing invasive mechanical ventilation through an endotracheal tube
排除标准
- •Anticipated need for mechanical ventilation less than 24 hours
结局指标
主要结局
Structure, thickness, and presence of microbes of biofilm developed on endotracheal tube
时间窗: After finished mechanical ventilation and extubation; expected average time on mechanical ventilation 5 days
Pieces of the tubes examined with electron microscopy and assessed for microbes
次要结局
- Length of stay, ICU and Hospital(Three months from study inclusion)
- Survival(Three months from study inclusion)
- White Blood Cell count(From admission to extubation. Expected average 5 days)
- C reactive protein(From admission to extubation. Expected average 5 days)