NCT00813371撤回不适用
Airway Pressure Release Ventilation as a Preventative Strategy in Patients at Risk for Acute Respiratory Distress Syndrome
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- The primary endpoint will be the number of ventilator-free days.
研究概览
简要总结
The early initiation of Airway Pressure Release Ventilation in multi-system trauma patients decreases the incidence and severity of acute lung injury and Acute Respiratory Distress Syndrome and allows faster recovery of lung function.
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
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Trauma patients age 16 or older
- •Trauma patients requiring ventilatory support within 48 hours of injury
- •Those with anticipated ventilatory support ≥ 24 hours
- •Subject or authorized representative (AR) has signed an informed consent form (ICF)
- •Subjects age 16 or 17 who have signed an assent document and/or AR has signed an ICF
排除标准
- •Significant chronic lung disease defined as lung pathology requiring home O2 use
- •Chronic heart disease defined as NYHC III or higher
- •Persistent bronchopulmonary air leak
- •Contraindications to permissive hypercapnia (ex. Intracerebral bleeding, brain tumor, fulminant hepatic failure, and hemodynamic instability)
- •Pulmonary artery occlusion pressures ≥ 18 mmHg
- •Severe neurologic injury that may prevent the patient from having a reasonable opportunity for weaning as determined by the clinical study team
- •Immuno-compromised patients secondary to drugs or disease
- •Neuromuscular disease that impairs ability to ventilate spontaneously (ex. Spinal injury at or above C5, ALS, Guillain-Barre syndrome, Myasthenia Gravis)
- •History of pneumonectomy
- •Pregnancy
- •Burns with TBSA ≥ 20%
- •Acute MI as the cause of ALI/ARDS
- •All other contraindications to APRV
- •Patients who cannot be randomized within 12 hours of intubation
结局指标
主要结局
The primary endpoint will be the number of ventilator-free days.
时间窗: from randomization to study termination
次要结局
- effects of ventilator mode on ventilation(duration of ventilatory assistance)
- duration of ICU stay(time in ICU)
研究者
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