NCT01682486已完成不适用
Evaluation of Tolerability, Safety and Performance of BIP Endotracheal Tubes With Bactiguard Coating
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Tolerability assessment by using a symptom questionnaire (QLQ-H&N35) before and after surgery. Evaluation of tracheal mucosa directly during surgery and after the end of study by using photos.
研究概览
简要总结
The objective of the study is to determine Bactiguard coated BIP Endotracheal tube´s tolerability, safety and performance and compare it to a standard un-coated Endotracheal tube.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
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
- •adult men and women >=18 years of age
- •are, in opinion of the investigator able to communicate with and understand the trial personnel and comply with the requirements of the trial (e.g. fill in questionnaire)
- •requiring endotracheal intubation >=3 h for elective surgery of upper gastrointestinal tract with a tube size of 7 or 8
- •has signed informed consent
排除标准
- •known transmissive blood disease
- •known multiresistant bacterial colonization
- •current and continuous treatment by immunomodulating therapies - e.g. systemic (or inhalation) use of cortisone or NSAIDS
- •ongoing respiratory infection
结局指标
主要结局
Tolerability assessment by using a symptom questionnaire (QLQ-H&N35) before and after surgery. Evaluation of tracheal mucosa directly during surgery and after the end of study by using photos.
时间窗: Change from Baseline in symptoms and tracheal mucosa after surgery of expected average length of 5 hours
次要结局
- Overall assessment of safety (device related adverse events and any problems in post postoperative course)(Participants will be followed on the surgery day and the day after surgery)
- Overall assessment of device performance(The performance will be followed during surgery of an expected average duration of 5 hours)
研究者
研究点 (2)
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