NCT01280383撤回1 期
Non-invasive Neurally Adjusted Ventilatory Assist (niNAVA) After Extubation: Proposal for a Crossover-randomized Feasibility Trial
适应症
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- patient-ventilator synchrony
研究概览
简要总结
Neurally adjusted ventilatory assist (NAVA) is a new concept of mechanical ventilation. NAVA delivers assistance to spontaneous breathing based on the detection of the electrical activity of the diaphragm. The investigators will study the effects of non-invasive NAVA on respiratory muscle unloading critically ill patients.
详细描述
To assess the effects of non-invasive NAVA on respiratory muscle unloading in critically ill patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 85 years
- •History of chronic obstructive lung disease
- •Invasive mechanical ventilation for more than 12 hours
- •Planned extubation according to the weaning protocol of our clinic
- •Informed consent obtained from a next of kin
- •Enrollment approval from a neutral physician neither participating in the study nor in the clinical treatment of the patient
排除标准
- •Tracheostomy
- •Facial or cranial trauma or surgery
- •Oral, esophageal, diaphragmatic or gastric trauma or surgery
- •Contraindication to insertion of a nasogastric tube (e. g. malformation, esophageal varices, esophageal perforation or rupture, Zenkers diverticulum, severe bleeding disorder)
- •Uncooperative state and combativeness not responding to low levels of sedatives
- •Neurological disease possibly influencing the brainstem respiratory centre, such as but not limited to: intracerebral, subarachnoidal or subdural hemorrhage, cerebral infarction, possible hypoxic encephalopathy
- •Next of kin refuses informed consent
- •Pregnancy. In female patients between 18 and 60 years of age, a pregnancy test will be performed.
结局指标
主要结局
patient-ventilator synchrony
时间窗: outcomes are assessed at the end of each experimental period, i.e. every 20-30 minutes
次要结局
- changes in respiratory pattern(study duration)
研究者
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