NCT01150864已完成不适用
Effects of Airway Conditioning Devices on Ventilator Associated Pneumonia:a Randomized Clinical Trial
Università degli Studi dell'Insubria2 个研究点 分布在 1 个国家目标入组 190 人开始时间: 2010年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 190
- 试验地点
- 2
- 主要终点
- Reduction of ventilator associated pneumonia
研究概览
简要总结
The main hypothesis are:
- Passive and Active-Passive airway conditioning devices reduce the incidence of ventilator associated pneumonia
- Active-Passive airway conditioning devices reduce the incidence of endotracheal tube obstruction
- Nurses' workload is reduced with Passive and Active-Passive airway conditioning devices
详细描述
For all Three lines of the study we record Clinical Pulmonary Infection score and Airways Care Score, SOFA (Sequential Organ Failure Assessment), sedation strategy, Glasgow Coma Score and clinical data.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients mechanically ventilated with PaO2/FiO2 lower than 300
- •Age higher than 18 years
- •Invasive mechanical ventilation
- •Endotracheal intubation or tracheostomy for more than 24 hours
排除标准
- •Non invasive ventilation
- •Severe ARDS (PaO2/FiO2 lower than 100, or PaCO2 higher than 60 mmHg)
- •Inefficient cough
- •Head Trauma
- •Spinal cervical trauma
- •Chest trauma
- •Pregnancy
- •Expectance of poor survival within 72 hours
- •Congenital airway disease
- •Immunosuppression
- •Supraglottic aspiration devices
结局指标
主要结局
Reduction of ventilator associated pneumonia
时间窗: 2 years
development of ventilator associated pneumonia after 48 hours of mechanical ventilation
次要结局
- Endotracheal tube obstruction(2 years)
- nurses' workload(2 years)
研究者
Paolo Severgnini
MD
Università degli Studi dell'Insubria
研究点 (2)
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