Weaning Using Noninvasive Positive Pressure Ventilation by Means of Helmet in Patients With Acute Respiratory Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Weaning using noninvasive positive pressure ventilation by means of helmet in patients with acute respiratory failure
研究概览
简要总结
The purpose of this study is to determine whether helmet is effective as device for noninvasive positive pressure ventilation in the weaning from mechanical ventilation.
详细描述
The clinical efficacy of noninvasive positive pressure ventilation (NPPV) has been demonstrated. Interest has emerged in using NPPV to facilitate earlier removal of an endotracheal tube and decrease complications associated with prolonged intubation. Studies assessing NPPV in weaning are not enough and generally are performed with face masks as device for NPPV. This study assesses the efficacy of helmet as device for NPPV during weaning from mechanical ventilation in an ICU and compares this procedure with invasive mechanical complication (IMV) by analyzing respiratory parameters, clinical course and complications.
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
- •endotracheal mechanical ventilation for 48 hours or more for acute respiratory failure,
- •patient ready to be weaned (steady respiratory and hemodynamic conditions for 24 hours),
- •spontaneous breathing trial failure
- •written informed consent obtained (patient or family)
排除标准
- •respiratory and hemodynamic instability
- •initial difficult intubation
- •bronchial hypersecretion at the weaning time
- •non cooperant patient
- •recent history of upper gastro-intestinal surgery
- •recent history of myocardial infarction
研究组 & 干预措施
Helmet NPPV
Weaning from mechanical ventilation with noninvasive positive pressure ventilation (NPPV)delivered by means of the helmet
干预措施: Helmet (Device)
ETT IMV
Weaning from mechanical ventilation with standard invasive mechanical ventilation (IMV) delivered by means of the endotracheal tube (ETT)
干预措施: Endotracheal tube (Device)
结局指标
主要结局
Weaning using noninvasive positive pressure ventilation by means of helmet in patients with acute respiratory failure
时间窗: 30 days
Main end-point defined as the weaning success/failure rate
次要结局
- Weaning using noninvasive positive pressure ventilation by means of helmet in patients with acute respiratory failure(180 days)