Is Positive Pressure Extubation Safe Procedure? A Randomized Non-inferiority Trial.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 198
- 试验地点
- 2
- 主要终点
- Presence/A presence/absence of complications after extubation
研究概览
简要总结
Laboratory studies suggest extubation with positive pressure because it reduces the volume of secretions filtered into the distal airway. The aim of this non inferiority study is to evaluate the safety of the extubation technique under positive pressure with respect to the traditional technique (with suction and without positive pressure in the airways).
详细描述
The extubation procedure consists of the removal of the endotracheal tube when it is no longer required. The literature reports two methods of extubation: the named traditional method (with suction and without positive pressure in the airways) and the positive pressure method. Laboratory studies suggest extubation at positive pressure because it reduces the volume of secretions filtered into the distal airway. Prior to apply it into clinical practice the investigators of this study consider is a priority to guarantee the safety of the positive pressure extubation method in terms of presence of complications.
The aim of this non-inferiority study is to compare the incidence of complications between both extubation techniques in adult patients with invasive mechanical ventilation.
The hypothesis of this study is that applying positive pressure during cuff deflation and extubation is not inferior to the traditional method in the incidence of 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
- Double (Investigator, Outcomes Assessor)
盲法说明
The pre and post extubation parameters are recorded by an outcome assessor who do not know the assigned extubation method.
The assigned extubation method is coded to minimize potential bias during data analysis.
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
- •Invasive Mechanical Ventilation with endotracheal tube.
- •18 years and older.
- •Successful 30 minutes spontaneous breathing trial (SBT).
- •Extubation Criteria.
- •Informed consent.
排除标准
- •Previous airway surgery or injury.
- •Non-Invasive Ventilation as weaning method.
结局指标
主要结局
Presence/A presence/absence of complications after extubation
时间窗: 60 minutes
Clinical Evidence of at least one of the next complications: persistent cough, airway obstruction, post-obstructive pulmonary edema, bronchospasm, desaturation, vomiting, tachycardia, arterial hypertension.
次要结局
- Pneumonia(72 hours)
- Reintubation(72 hours)
研究者
Mauro Andreu
Physical Therapist
Hospital Donación Francisco Santojanni