Chlorhexidine Gluconate for Prevention of Ventilator Associated Pneumonia in a Pediatric Intensive Care Unit.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Incidence of ventilator associated pneumonia
研究概览
简要总结
To determine the efficacy of prophylaxis with 0.12% chlorhexidine gluconate compared with placebo to prevent ventilator associated pneumonia in children admitted to a pediatric critical care unit.
详细描述
Randomised controlled trial to determine the efficacy of 0.12% chlorhexidine gluconate compared with placebo to prevent ventilator associated pneumonia in children admitted to a pediatric critical care unit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 1 month to 18 years admitted to the intensive care unit.
- •Intubated for more than 48 hours.
排除标准
- •Clinical or radiological diagnosis of pneumonia previous to the endotracheal intubation.
- •Allergy to chlorhexidine.
- •Known immune deficiency.
- •Elimination Criteria:
- •Transfer to another hospital.
研究组 & 干预措施
0.12% Chlorhexidine
Bexident® (0.12% chlorhexidine) solution, applied topically, every 8 hrs.
干预措施: 0.12% chlorhexidine solution (Drug)
Placebo
7.4% alcohol, glycerine, normal saline solution, applied topically, every 8 hrs.
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of ventilator associated pneumonia
时间窗: Participants will be followed for the duration of intensive care unit stay, an expected average of 2 weeks
次要结局
- Mortality(Participants will be followed for the duration of intensive care unit stay, an expected average of 2 weeks)
- Days of mechanical ventilation(From date of randomization until the date of death or date of extubation, whichever comes first, an expected average of 2 weeks)
- Length of stay(From date of randomization until the date of death or date of discharge from the intensive care unit, an expected average of 2 weeks)
研究者
Jesús Javier Martínez-García
MD
Sinaloa Pediatric Hospital