NCT00184925终止不适用
The Development of Ventilator Associated Pneumonia and Late Complications of Two Different Percutaneous Tracheostomy Techniques
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Clinical Pulmonary Infection Score first week on day 0-2-4-6 and after the first week on indication.
研究概览
简要总结
The purpose of this study is to investigate the incidence of ventilator associated pneumonia and late complications by comparing two different cannulas and two different percutaneous tracheostomy techniques.
详细描述
This study did not generate the expectations's we've expected, therefore, the analysis was prematurely stopped...
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •all patients on the intensive care unit who receive a tracheostomy.
排除标准
- •use of immunosuppressive
- •with regard to the MRI-scan patients who have a pacemaker and/or who are claustrophobic
结局指标
主要结局
Clinical Pulmonary Infection Score first week on day 0-2-4-6 and after the first week on indication.
时间窗: 1 year
次要结局
- -Late complications: complications occuring after removal of the tracheostomy tube.(1 year)
- Two weeks and three months after decannulation: Forced oscillation technique.(1 year)
- Peri-operative complications: procedure-related complications occurring within 24 hours of the procedure.(1 year)
- Three months after decannulation ENT-specialist control and MRI-scan to see whether there are signs or symptoms of tracheal stenosis.(1 year)
- Post-operative complications: divided into 'complications while cannulated' and 'late complications'.(1 year)
- - Complications while cannulated: complications occurring after 24 hours until removal of the tracheostomy tube.(1 year)
研究者
Bernard Fikkers
Md, PhD
Radboud University Medical Center
研究点 (2)
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