Occurrence of Ventilator Associated Pneumonia (VAP) in Italian ICU Using Cuffed Tracheostomy Tubes With Subglottic Secretion Drainage: a Prospective Observational Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Incidence of VAP
研究概览
简要总结
Ventilator-associated pneumonia (VAP) is a serious complication and carries increased risks of morbidity and mortality for patients who require mechanical ventilation.
VAP is associated with the contamination and colonization of bacteria in the lower airway. These bacteria may be present in the lower airway by the aspiration of oropharyngeal secretions. Therefore limiting the amount of secretions that pass the glottis and enter the airway is paramount.
Patients who require prolonged mechanical ventilation may have a tracheostomy tube placed to manage breathing. These tubes may have a distal cuff which sits within the trachea. When the cuff is inflated, oropharyngeal secretions will pool above the cuff of the tracheostomy tube thereby limiting the amount of secretions entering the lower airway. These secretions may leak around the cuff and cause tracheobronchial colonization. It has been shown that removal of secretions that pool above the cuff via dorsal lumen suction leads to a decreased incidence of VAP.
The purpose of this study is to measure the effect of suction above the cuff tracheostomy tubes related to VAP incidence
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patients on mechanical ventilation for respiratory failure for at least 72 hours.
- •A score of 35 to 65 on the Simplified Acute Physiology Score II (SAPS II).
- •Does not have a pulmonary infection estimated by a Clinical Pulmonary Infection Score (CPIS).
- •Age >= 18 years.
排除标准
- •Exclusion Criteria:
- •A history of esophageal, tracheal or pulmonary cancer or an existing malignancy within the trachea at the tracheostomy site.
- •Previous surgery at the tracheostomy site (e.g. thyroidectomy).
- •Bleeding diathesis (e.g. due to anticoagulation therapy).
- •Emergency surgical airway management.
- •Morbid obesity and/or neck edema (skin to trachea distance may render tracheostomy tube too short).
- •Pre-existing infection at the tracheostomy site.
- •Uncertainty in identifying the anatomical landmarks.
- •Patients with a do not resuscitate order.
- •Immunosuppressed and/or immunodepressed patients (Immunodepression being defined by the following conditions: 1-Leukocytes < 1000/µl, 2-Neutrophils < 500/µl. 3-AIDS 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
Incidence of VAP
时间窗: at 28 days
次要结局
- ICU length of stay(30 days)
- Duration of mechanical ventilation(30 days)
- Mortality rate(at 28 days)
- Ventilator free days after tracheostomy(28 days)
研究者
Marco Ranieri
MD
University of Turin, Italy