A Randomised Controlled Trial of Continuous Endotracheal Cuff Pressure Control for the Prevention of Ventilator Associated Respiratory Infections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 3
- 主要终点
- Ventilator Associated Respiratory Infection (VARI) - defined as Ventilator Associated Pneumonia (VAP) or Ventilator Associated Tracheobronchitis (VAT)
研究概览
简要总结
The purpose of the study is to determine whether automated cuff pressure control results in a reduction in the proportion of patients developing ventilator associated respiratory infections during their stay in intensive care.
详细描述
The proposed study is a randomized controlled trial of tracheal cuff pressure control using continuous control via an automated electronic device as compared with intermittent pressure control for the prevention of ventilator associated respiratory infection in ICU.
The study will be conducted at multiple sites in Vietnam. Recruitment will be for 18 months at all centers. Patients experiencing any hospital acquired infection whilst at risk of Ventilator Associated Respiratory Infections will be evaluated in using a standardised investigation protocol to identify cases of VARI and other hospital acquired infections (HAI)s. Assessment of VARI will be based on published criteria and carried out by an endpoint review committee independent of patient care and blinded to the allocation of the patient. Antibiotic use data and duration of stay will be important secondary outcome measures.
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
- Single (Outcomes Assessor)
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
- •About to be intubated or intubated for ≤ 24 hours (either oral or tracheostomy)
- •For active treatment
排除标准
- •previously enrolled in this study
- •previously intubated within 14 days
- •suffering from known tracheomalacia, tracheal stenosis or stridor relating to tracheal injury
结局指标
主要结局
Ventilator Associated Respiratory Infection (VARI) - defined as Ventilator Associated Pneumonia (VAP) or Ventilator Associated Tracheobronchitis (VAT)
时间窗: From randomisation to ICU discharge/death/transfer or 90 days
次要结局
- Intubated days receiving antibiotics(From randomisation to ICU discharge/death/transfer or 90 days)
- ICU mortality(From randomisation to discharge from ICU or death/palliative discharge from it or 90 days)
- Hospital mortality(From randomisation to discharge from ICU or death/palliative discharge from it or 90 days)
- Microbiologically confirmed VARI defined as above plus bacterial growth of ≥105 cfu/ml (ETA) or equivalent semi-quantitative for both VAP and VAT(From randomisation to ICU discharge/death/transfer or 90 days)
- Cost of ICU stay(From ICU admission to ICU discharge, death, transfer or 90 days)
- Cost of antibiotics in ICU stay(From ICU admission to ICU discharge, death, transfer or 90 days)
- Cost of hospital stay(From hospital admission to hospital discharge or 90 days)
- 28 day mortality(From randomisation to 28 days after randomisation)
- Clinical and microbiologically confirmed VAP (see above for definitions)(From randomisation to ICU discharge/death/transfer or 90 days)
- Incidence of hospital acquired infection(From randomisation to extubation/death/transfer/discharge/ from ICU or 90 days)
- Total number of days ventilated/in ICU(From randomisation to ICU discharge, death, transfer or 90 days)
- 90 day mortality(From randomisation to 90 days after randomisation)