Comparison of High Flow Nasal Cannula With Noninvasive Ventilation in Facilitating Weaning Chronic Obstructive Pulmonary Disease From Invasive Ventilation: a Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- pH
研究概览
简要总结
High flow nasal cannula (HFNC) has been shown to improve oxygenation and facilitate weaning in hypoxemia patients. Some clinical studies show the benefits of using HFNC in COPD patients, including reducing dead space and work of breathing. However, no clinical study has been to investigate the value of HFNC in weaning COPD patients from invasive ventilation. Thus, we proposed a randomized controlled trial to compare the use of HFNC and noninvasive ventilation (NIV) in weaning COPD.
详细描述
High flow nasal cannula (HFNC) provides high concentration oxygen in a high flow, which exceeds patient's inspiratory flow demand, to improve oxygenation. In a recent meta-analysis of seven trials with 1771 patients, HFNC was shown to improve oxygenation and avoid intubation in patients with severe hypoxemia. The high velocity of the gas can rinse the dead space of the upper airway and reduce CO2 rebreathing, reduce COPD patients' work of breathing and improve the dynamic compliance of respiratory system.
Thus, we proposed a randomized controlled trial to investigate the value of high flow nasal cannula in weaning AECOPD patients from invasive ventilation, with comparison of noninvasive ventilation.
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
- 21 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Intubated patients with Chronic obstructive pulmonary disease exacerbation
- •Meeting extubation criteria (Pulmonary infection control window)
- •Age > 21years and < 90 years
排除标准
- •Tracheotomy
- •Combined with severe dysfunction of other organs, including heart, brain, liver, and renal failure;
- •Hemodynamic instability
- •Contraindication to NIV: cannot use mask, such as facial injury, burns or deformities; cannot cooperate with NIV such as delirium; copious secretions with weak cough ability; gastric over distention, and vomiting;
- •Contraindication to HFNC: rhinitis, nasal congestion, deformities or blockage.
- •Weak cough ability with copious secretions
- •Refuse to participate in the study
研究组 & 干预措施
High flow nasal cannula
High flow nasal cannula (HFNC) is a type of oxygen device, which provides high concentration oxygen in a high flow, which exceeds patient's inspiratory flow demand, to improve oxygenation.
干预措施: High flow nasal cannula (Device)
Noninvasive ventilation
Non-invasive ventilation (NIV) refers to the provision of ventilatory support through the patient's upper airway using a mask. This technique is distinguished from those which bypass the upper airway with a tracheal tube, laryngeal mask, or tracheostomy and are therefore considered invasive.
干预措施: Noninvasive ventilation (Device)
结局指标
主要结局
pH
时间窗: change from the baseline pH within 48 hours
pH
PaO2/FiO2
时间窗: change from the baseline PaO2/FiO2 within 48 hours
partial pressure of oxygen in arterial blood/ fraction of inspired oxygen in mmHg
RR
时间窗: change from the baseline RR within 48 hours
respiratory rate in breaths per minute
HR
时间窗: change from the baseline HR within 48 hours
Heart Rate in beats per minute
PaCO2
时间窗: change from the baseline PaCO2 within 48 hours
PaCO2 in mmHg
MAP
时间窗: change from the baseline MAP within 48 hours
mean arterial pressure in mmHg
次要结局
- incidence of barotrauma(28 days)
- the patients' comfort score(48 hours)
- Mortality(28 days)
- incidence of nasal trauma(28 days)
- duration of respiratory support(28 days)
- Length of ICU stay(28 days)
研究者
Jie Li
Clinical education coordinator
Rush University Medical Center