Clinical Impact of Lung Ultrasound Monitoring for Diagnosis of Ventilator Associated Pneumonia: a Diagnostic Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- ventilator free days
研究概览
简要总结
The study evaluates whether lung ultrasound monitoring could lead to earlier detection of ventilator associated pneumonia and influence outcome. Half of the participants will be diagnosed with VAP using a combination of lung ultrasound and clinical features and half will be diagnosed using the Johanson criteria, which is a combination of clinical features and chest x-ray.
详细描述
The current guidelines recommend the use of chest x-ray or computed tomography of the chest to aid in the diagnosis of VAP. However many studies have shown that chest x-ray is neither very sensitive nor specific for pneumonia, and computed tomography, though has the highest diagnostic accuracy, is not routinely performed due to logistics, safety concerns, economics and radiation exposure.
Emerging studies including meta-analyses have shown high sensitivity and specificity of lung ultrasound in diagnosing pneumonia. When combined with clinical and microbiological features it has shown to be helpful in early diagnosis of VAP, but a study to show whether such early detection improves outcome is lacking.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •Mechanical ventilation for more than 48 hours
- •Absence of pneumonia as the reason for mechanical ventilation (includes clinical, radiological or sonographic diagnosis)
排除标准
- •Recent trauma or surgery to the thorax (including chest tube insertion)
- •Presence of dressings or skin conditions restricting access to the thorax
- •Confirmed pregnancy
- •If already enrolled in the study
- •Denial of consent
研究组 & 干预措施
Lung ultrasound
Patients will be monitored for ventilator associated pneumonia using lung ultrasound combined with clinical features
干预措施: lung ultrasound (Diagnostic Test)
Chest x-ray
Patients will be monitored for ventilator associated pneumonia using chest x-ray and clinical features.
结局指标
主要结局
ventilator free days
时间窗: day 28 from diagnosis of VAP
number of days alive from day 1 (of VAP) to day 28 on which a patient breathes without assistance, if the period of unassisted breathing lasted at least 48 consecutive hours. If death occurs within 28 days then ventilator free days is counted as 0
次要结局
- delta sofa(day 4 from VAP diagnosis)
- antibiotic duration(day 14 from initiation of antibiotic)
- icu mortality(through study completion, an average of 3 months)
- ventilator days(day 28 from intubation)
- icu length of stay(through study completion, an average of 3 months)
研究者
Saurabh Pradhan
MD, DM (Critical care medicine)
Tribhuvan University Teaching Hospital, Institute Of Medicine.