Efficacy of Early Tracheostomy to Reduce Incidence of Ventilator Acquired Pneumonia (VAP)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 320
- 试验地点
- 2
- 主要终点
- Increase of "ventilator associated pneumonia-free days"
研究概览
简要总结
The study aims to assess early (one to three days after intubation) tracheostomy effectiveness in terms of reduction in ventilator associated pneumonia (VAP) incidence.
详细描述
Tracheostomy is an essential and irreplaceable procedure for critically ill patients requiring mechanical ventilatory support and adequate airway control. The therapeutical choice of performing a tracheostomy is supported by a number of clinical benefits, such as less use of drugs for sedation, fewer days of mechanical ventilation and hence shorter Intensive Care Unit (ICU) length of stay, as well as better resource rationalization. Actually there is no agreement on the best timing for tracheostomy. The aim of this study is to verify if an early tracheostomy (one to three days after intubation) increases ventilator associated pneumonia-free days. Secondary endpoints are: increase of ventilator free-days and mortality reduction.
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
- 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
- •Oro/nasotracheal intubation for less than three days
- •Simplified Acute Physiology Score (SAPS II) between 35 and 65 upon admission to Intensive Care Unit (ICU)
排除标准
- •Oro/nasotracheal intubation > three days
- •Age < 18 years
- •Previous otolaryngologic or maxillofacial procedures
- •Brain injury patients with intracranial pressure > 20 mmHg without pharmacological treatment (or intracranial pressure > 15 mmHg under specific pharmacological treatment) and with cerebral perfusion pressure < 60 mmHg
- •Pregnancy
- •Ventilator associated pneumonia, hospital acquired pneumonia, community acquired pneumonia diagnosis before randomization
- •Infection in the tracheostomic area
- •Acute worsening of chronic obstructive pulmonary disease (COPD)
- •Pre-existing malignancies in the tracheostomic area
- •Immunosuppressed and/or immunodepressed patients:
- •leukocytes < 1000/microliters
- •neutrophils < 500/microliters
- •long-term steroid treatment (daily dose > 0.5 mg/kg for more than 30 days)
- •Patients already enrolled in other trials
结局指标
主要结局
Increase of "ventilator associated pneumonia-free days"
时间窗: Follow-up terminates on day 28 from the date of oro/nasotracheal intubation.
次要结局
- Increase of "ventilator-free days"(Follow-up terminates on day 28 from the date of oro/nasotracheal intubation)
- Reduction of mortality(one year)
研究者
Marco Ranieri
MD
University of Turin, Italy