NCT04125342已完成不适用
Effect of Postextubation High-Flow Nasal Cannula vs Noninvasive Ventilation on Reintubation in Obese or High-Risk Patients. A Randomized Clinical Trial.
Hospital Virgen de la Salud4 个研究点 分布在 1 个国家目标入组 326 人开始时间: 2020年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 326
- 试验地点
- 4
- 主要终点
- Reintubation rate
研究概览
简要总结
The main aim is to demonstrate whether reintubation rate is lower with preventive conditioned noninvasive ventilation (NIV) rather than with High-flow oxygen therapy (HFOT) in obese intermediate-risk patients and in high-risk patients.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •High-Risk Patients: Patients under mechanical ventilation for more than 24 hours considered at high risk according to the presence of more than 3 of the following risk factors:
- •>65 years.
- •Cardiac failure as the primary indication of mechanical ventilation.
- •Moderate to severe chronic obstructive pulmonary disease.
- •APACHE II >12 points the extubation day.
- •Body mass index >
- •Inability to manage respiratory secretions.
- •Not simple weaning.
- •More than 1 comorbidity.
- •More than 7 days under mechanical ventilation.
- •Hypercapnia during the spontaneous breathing trial.
- •Airway patency problems.
- •Obese Intermediate Risk Patients: Patients under mechanical ventilation for more than 24 hours with a Body mass index >30 and considered at intermediate risk according to the presence of less than 3 of the following risk factors:
- •>65 years.
- •Cardiac failure as the primary indication of mechanical ventilation.
- •Moderate to severe chronic obstructive pulmonary disease.
- •APACHE II >12 points the extubation day.
- •Inability to manage respiratory secretions.
- •Not simple weaning.
- •More than 1 comorbidity.
- •More than 7 days under mechanical ventilation.
- •Airway patency problems.
排除标准
- •<18 years.
- •Thacheotomized patients.
- •Contraindications for NIV (recent facial or cervical trauma/surgery, active gastro-intestinal bleeding, lack of cooperation).
- •Unscheduled extubation.
- •Do not reintubate orders.
- •No informed consent.
结局指标
主要结局
Reintubation rate
时间窗: 7 days
次要结局
- Intensive Care Unit length of stay(3 months)
- Hospital mortality rate(3 months)
- Hospital length of stay(6 months)
- Intensive Care Unit mortality rate(3 months)
- Respiratory infection rate(6 months)
研究者
Gonzalo Hernandez Martinez
Study Chair
Hospital Virgen de la Salud
研究点 (4)
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