Multi-center Clinical Trial of the Bard Silver-coated Endotracheal Tube to Reduce Ventilator Associated Pneumonia (VAP)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,003
- 试验地点
- 10
- 主要终点
- The incidence of microbiologically-confirmed VAP (mVAP), as determined by quantitative culture of bronchoalveolar lavage fluid, in subjects intubated for >=24 hours.
研究概览
简要总结
The purpose of this study is to determine if the use of a silver-coated endotracheal tube (ETT) can reduce the incidence and/or delay the time of onset of VAP when compared to a non silver-coated ETT in patients who have been mechanically ventilated for >= 24 hours.
详细描述
Nosocomial pneumonia is the leading cause of death from hospital-acquired infections.Ventilator associated pneumonia (VAP) develops in a significant percentage of patients who have been ventilated for at least 48 hours, and is associated with high morbidity, mortality,and financial costs. Silver is a well-characterized antimicrobial agent, and is the active agent in multiple medical products used to reduce or control infection. Bard has developed a proprietary antimicrobial ETT, manufactured with a hydrophilic coating containing a fine dispersion of silver salts.
This study compare the incidence and time to onset of VAP in patients intubated for >=24 hours with a proprietary silver-coated ETT versus those intubated for >= 24 hours with a standard non-coated ETT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, 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
- •age > 18 years
- •expected to be intubated for at least 24 hours
- •able to sign Informed Consent
排除标准
- •symptoms of bronchiectasis
- •severe hemoptysis
- •history of cystic fibrosis
- •intubated > 12 hours within previous 30 days
- •pregnancy
- •participating in a competing trial
结局指标
主要结局
The incidence of microbiologically-confirmed VAP (mVAP), as determined by quantitative culture of bronchoalveolar lavage fluid, in subjects intubated for >=24 hours.
时间窗: 30 days
次要结局
- time to onset of mVAP in subjects intubated for >=24 hours(30 days)
- duration of intubation(unlimited)
- mortality(unlimited)
- antibiotic usage(unlimited)
- length of stay(unlimited)
- incidence of clinical VAP in subjects intubed for >=24 hours(30 days)