High-Flow Nasal Oxygen Therapy for Exacerbation of Chronic Pulmonary Obstructive Disease: A Randomized, Open-label, Single-center, Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- PaO2/FiO2 ratio at 24 hours
研究概览
简要总结
High-Flow Nasal Oxygen (HFNO) therapy has never been tested against Noninvasive ventilation, the reference standard therapy for acute exacerbation of chronic obstructive pulmonary disease (COPD), in randomized clinical trials.
The aim of the present study is to compare the effects of HFNO therapy on arterial blood gas variables over the first 24 hours of therapy, to those of Noninvasive ventilation, in patients experiencing a moderate (i.e. with arterial pH within 7.25-7.35) exacerbation of COPD.
详细描述
As soon as admission to the intensive care unit, eligible patients who gave consent will be randomized to either HFNO or Noninvasive ventilation therapy for at least the first 24 hours.
In the usual care group , Noninvasive ventilation will be applied in alternance with standard nasal oxygen therapy.
In the intervention group, HFNO with be applied continuously over the first 24 hours.
In both groups, an oxygen saturation, as assessed by finger pulse oximetry, of 88-92% will be targeted.
The primary objective will be two-fold: to compare between groups 1) Efficacy, assessed by the arterial pH at 24 hours, and 2) Safety, assessed by the ratio of the arterial partial pressure in oxygen (PaO2) over the inspired oxygen fraction (FiO2) at 24 hours.
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
- •Age > 18
- •Known Chronic Obstructive Pulmonary disease (COPD)
- •respiratory rate or presence of accessory respiratory muscles activity on physical exam
- •moderate exacerbation of COPD as defined by an arteria pH between 7.25 and 7.35 and an arterial carbon dioxide partial pressure (PaCO2) equal or above 45 mm Hg
排除标准
- •Age below 18
- •Pregnancy
- •Known sleep apnea syndrome
- •Patent treated by noninvasive ventilation at home
- •Not affiliated to French scial security
- •Contraindication to aither Noninvasive ventilation or to High-Flow Nasal Oxygen therapy
- •Previous inclusion in the study
结局指标
主要结局
PaO2/FiO2 ratio at 24 hours
时间窗: 24 hours
PaO2/FiO2 ratio at 24 hours, the primary safety criteria, is planned to be jointly assessed and analysed with the primary efficacy criteria (arterial pH at 24 hours)
Arterial pH at 24 hours
时间窗: 24 hours
Arterial pH at 24 hours, the primary efficacy criteria, is planned to be jointly assessed and analysed with the primary safety criteria (PaO2/FiO2 ratio at 24 hours)
次要结局
- Severe Adverse events(28 days)
- Cumulative incidence of tracheal intubation(28 days)
- Perceived nursing workload(24 hours)
- Proportion of patients who will need Noninvasive ventilation in the High-Flow Nasal Oxygen group from randomisation through the 24th hour(24 hours)
- Time course of arterial pH(24 hours)
- Arterial partial pressure in carbon dioxide (PaCO2)(24 hours)
- Time course of arterial oxygen saturation (SaO2)(24 hours)
- Self-reported dyspnea score(24 hours)