Prospective, Randomized, Multi-Center Trial of Lateral Trendelenburg Versus Semi-Recumbent Body Position in Mechanically Ventilated Patients For The Prevention of Ventilator-Associated Pneumonia
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 800
- 试验地点
- 4
- 主要终点
- Incidence of ventilator-associated pneumonia
研究概览
简要总结
This study is planned to compare, in patients sedated, intubated and mechanically ventilated, the efficacy and safety of the Lateral Trendelenburg position in comparison to the Semirecumbent Position to prevent incidence of ventilator-associated pneumonia (VAP).
详细描述
This study is planned to compare, in patients sedated, intubated or tracheostomized and mechanically ventilated, the efficacy and safety of two body positions in reducing incidence of ventilator-associated pneumonia. The semi-recumbent position prevents gastro-oropharyngeal aspiration of bacteria laden gastric contents and the "gastro-pulmonary" route of colonization. The lateral-Trendelenburg position aims to promote outward drainage of bacteria-laden oropharyngeal secretion, while avoiding bacterial translocation from the oropharynx into the lungs.
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 (Participant)
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
- •Age ≥ 18 years
- •Patients expected to be oro-tracheally intubated for at least 48 hours or longer
- •Enrollment time window within 12 hours following intubation
排除标准
- •Current and past participation in an other intervention trial conflicting with the present study
- •Previous endotracheal intubation longer than 12 hours during the previous 30 days
- •Patients with documented bronchiectasis
- •Cystic fibrosis
- •Witnessed pulmonary aspiration either prior or at intubation
- •Patients with increased intracranial pressure, brain edema; or medical conditions that can worsen with increase in intracranial pressure
- •Patients with significant heart failure and activity impairment (Class III-IV of the New York Heart Association (NYHA)
- •Spinal cord injury
- •BMI > 35, or weight above 300 pound
- •Grade IV Intra-abdominal pressure: IAP > 25 mmHg or abdominal compartment syndrome , defined as a sustained IAP > 20 mmHg that is associated with new organ dysfunction / failure
- •Orthopedic problems that will not allow the patient to be kept in one of the study positions
结局指标
主要结局
Incidence of ventilator-associated pneumonia
时间窗: 14 days of mechanical ventilation
incidence of ventilator-associated pneumonia within the first 14 days of intubation, confirmed by quantitative microbiology analysis of either bronchoalveolar lavage (BAL) or mini-BAL fluids or secretions collected through protected specimen brush (PSB)
次要结局
- 28 Days mortality(28 days)
- Duration of hospital stay(days)
- Safety of the Semi-Recumbent and Lateral-Trendelenburg position(14 days)
- Duration of mechanical ventilation(14 days)
- Duration of intensive care unit stay(days)
- Use of Sedatives(14 days)
- Use of Antimicrobials(14 days)
- ICU mortality(28 days)
- Hospital mortality(28 days)
- Assessment of nursing-related issues in the lateral-Trendelenburg position(14 days)
研究者
Mauro Panigada, MD
MD
Policlinico Hospital