The Prevention of Primary Endogenous Ventilator-Associated Pneumonia: A Multicenter Randomized Trial Comparing Continuous Aspiration of Subglottic Content and a 3-Day Course of Ceftriaxone.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 6
- 主要终点
- Cumulative incidence of early-onset ventilator-associated pneumonia
研究概览
简要总结
The primary purpose of the trial is to compare the efficacy and safety of two measures which claim to prevent early-onset ventilator-associated pneumonia.
详细描述
Background: In a previous double-blind, placebo-controlled, randomized trial we found that a 3-day-course of ceftriaxone significantly reduced the incidence of early-onset ventilator-associated pneumonia (EOP). Continuous aspiration of secretions accumulating in the subglottic space above the cuff of the endotracheal tube has also been shown to prevent EOP.
Objective: To compare the effect of both preventive measures on the incidence of EOP.
Design: Randomized, multicenter.
Setting: Three general intensive care units at university hospitals in Spain. Patients: Patients without signs of infection and no concomitant systemic antibiotics were included if expected to require endotracheal intubation exceeding 2 days.
Intervention: All patients were intubated with an endotracheal tube equipped with a port for aspiration of subglottic secretions and subsequently randomized to receive a three day course of 2 gram/day iv ceftriaxone without aspiration of subglottic secretions or continuous aspiration of subglottic secretions.
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
- 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
- •Endotracheal intubation with endotracheal tube equipped with port for aspirations of subglottic contents and expected to exceed 48 hors.
- •Absence of infection.
- •18 years or older.
- •Informed Consent.
排除标准
- •Endotracheal intubation prior to admission to hospital.
- •Allergic to beta-lactam antibiotics.
- •Formal indication for systemic antibiotic therapy.
结局指标
主要结局
Cumulative incidence of early-onset ventilator-associated pneumonia
次要结局
- Duration of intubation and ICU-stay.
- ICU-Mortality.
- All ICU-acquired infections.
- Duration of antibiotic therapy.
- Third-generation cephalosporin resistance.