NCT00950027终止3 期
Prospective Randomized Double Blind Study Comparing the Effect of Oropharyngeal Decontamination by Povidone-iodine to Placebo on Ventilator-associated Pneumonia in Patients With Head Trauma or Cerebral Hemorrhage
Rennes University Hospital7 个研究点 分布在 1 个国家目标入组 179 人开始时间: 2008年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 179
- 试验地点
- 7
- 主要终点
- Rate of ventilator associated pneumonia
研究概览
简要总结
Head trauma and severe cerebral hemorrhage are major risk factors for development of ventilator-associated pneumonia. In a previous open labelled, single center study the investigators showed that repeated oropharyngeal decontamination with povidone-iodine may be an effective strategy to decrease the prevalence of ventilator-associated pneumonia in patients with head trauma. The present study aims to confirm these results in a multicenter, double blind study including patients suffering from head trauma or cerebral hemorrhage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, 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
- •Adults > 18 years
- •Closed head trauma with a Glasgow Coma Score <=8 or cerebral Hemorrhage with a Glasgow Coma Score of <=8
- •Expected need mechanical ventilation for >=2 days
- •Written informed consent from the patient's next-of-kin. If no relative is present at the time of inclusion, the patients will be included according to the emergency procedure
排除标准
- •Impossibility to perform oropharyngeal decontamination within 12 h following the initial episode
- •Facial injury with impossibility to perform the oropharyngeal decontamination
- •Tetraplegia
- •Known history of reaction to iodine
- •Respiratory disease or pulmonary infiltrate(s) at inclusion
- •Need for curative antibiotics
- •Mercurial antiseptics treatment
- •Pregnancy
研究组 & 干预措施
povidone iodine
Experimental
Povidone iodine
干预措施: povidone iodine (Drug)
placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Rate of ventilator associated pneumonia
时间窗: 30 days
次要结局
- Rate of early (<=7 days) and late (>7 days) ventilator associated pneumoniae(30 days)
- Length of ICU and hospital stay(Hospital discharge)
- Death(ICU, 1 months, 3 months)
- Type of anesthetic agents received(30 days)
- Oropharyngeal bacterial colonisation(30 days)
- Length of mechanical ventilation(30 days)
- Other infections(30 days)
- Acute respiratory distress syndrome(30 days)
- Time to ventilator associated pneumoniae(30 days)
- Treatments administered (antibiotics, sedatives, transfusion)(30 days)
- Rate of transfusion (red blood cells, platelets, plasma)(30 days)
- Rate of tracheostomy(30 days)
研究者
研究点 (7)
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