Aspiration of Bronchial Secretions with Mechanical Insufflation-Exsufflation and Hypertonic Saline in Bacterial Nosocomial Tracheobronchitis and Pneumonia in Intubated Patients.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 11
- 主要终点
- Median respiratory support-free days increase at day 28
研究概览
简要总结
Multicenter, randomized open label clinical trial to evaluate IEM and HS as concomitant therapy for respiratory tract infection in patients under artificial ventilation in the ICU.
Lung infection is a serious complication that may occur during hospital stay and may need artificial respiration or even develop during artificial ventilation for other causes.
Current specific treatment consists of intravenous antibiotics. The current study evaluated whether aspiration and drainage of infected sputum helps curing this severe complication and whether nebulized HS has additional benefits, like loosening of secretions, eradicating bacteria or reducing inflammation.
详细描述
Open label, randomized, multicenter (7 ICUs at 7 hospitals in Spain). The study has 2 main arms, pneumonia and tracheobronchitis.
If the diagnosis is pneumonia, subjects will be randomization to one of 3 study groups:
- IV Antibiotic therapy
- IV Antibiotic therapy + mechanical insufflation-Exsugglation (MI-E)
- IV Antibiotic therapy + MI-E + nebulized hypertonic saline-hyaluronic acid (HS)
If the diagnosis is tracheobronchitis,subjects will be randomization to one of 3 study groups:
- No specific therapy (recommendation of the Infectious Diseases Society of America)
- IV Antibiotic therapy (common practice to prevent progressión to pneumona and shorten duration of intubation)
- MI-E + HS
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
- •Signed informed consent
- •Nosocomial pneumonia (vHAP or VAP) or nosocomial tracheobronchitis
- •Intubated with a cuffed endotracheal tube or tracheostomy cannula.
排除标准
- •Ominous prognosis
- •Frank hemoptisis
- •Barotrauma (pneumothorax or pneumomediastinum)
- •Bronchospasm (patients on bronchodilators for previous bronchospasm may be included
- •Unstable thoracic cage
- •Suspected unmonitored intracraneal hypertension
结局指标
主要结局
Median respiratory support-free days increase at day 28
时间窗: Inclusion to day 28 after randomization
28 minus duration in days on high-flow nasal cannula + invasive ventilation.
Percentage of subjects surviving/dying day 28
时间窗: Inclusion to day 28 after randomization
crude mortality on day 28 after randomization
Median SOFA score increase >2 points on day 4
时间窗: inclusion to day 4 after randomization
Increase in organ dysfunction score from baseline to day 4 after randomization.
次要结局
- Subjects with bacterial eradication in respiratory samples at day 4 after randomization(Day 3 to 5 after randomization)
- Subjects with bacterial eradication in respiratory samples at end of systemic antibiotic therapy(7 and 14 days after randomization)
- Median Length of ICU stay(ICU admission to discharge or death in days)
- Median antibiotic-free days at 28 days(from study inclusion to day 28)
研究者
Miguel Sanchez Garcia
Emeritus Critical Care Department
Hospital San Carlos, Madrid