Evaluation of the Effectiveness of the Nebulization Bronchodilators Under High Nasal Flow Humidified Compared to a Usual Method
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Increased expiratory volume in one second ( FEV )
研究概览
简要总结
The principal objective is to show noninferiority of nebulized salbutamol through the high flow nasal system moistened AIRVO ™ 2 in terms of reversibility of airflow obstruction compared to nebulization by the usual method (spray mask).
详细描述
Randomized, comparative, non inferiority study between two nebulization strategies bronchodilators, one according to the method tested namely the spray - in across the top humidified nasal flow system and the other according to a customary procedure, through a mask. A third arm will be evaluated (control arm) to overcome a possible own bronchodilator effect of high flow nasal humidified.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with chronic obstructive pulmonary disease
- •Patients, when performing lung function tests performed outside of the study :
- •A report FEV / FVC less than 60% prior to bronchodilator treatment AND
- •A positive reversal test defined by FEV variation of over 12 % and 200 mL after administration of inhaled salbutamol
- •Patients affiliated to social security scheme
- •Informed consent signed by the patient
排除标准
- •Exacerbation of chronic obstructive pulmonary disease during
- •Uncontrolled asthma
- •Pneumothorax current or recent ( < 2 months)
- •Pleural aspiration or biopsy , trans - bronchial biopsies and / or bronchoalveolar lavage in the preceding 48h
- •hemoptysis in progress
- •Patient under guardianship or trusteeship safeguard justice
- •Pregnant or breastfeeding women or parturient woman
- •Known allergy or intolerance to salbutamol
研究组 & 干预措施
Airvo2 with Aerogen Solo
AIRVOTM2 will be set to deliver air (21% oxygen concentration ) at a rate of 30 L / min at 100 % relative humidity at 37 ° C.
Nebulization of salbutamol will be effected by means of a nebulizer to the vibrating screen (Aerogen® Solo, Aerogen , Galway, Ireland ) which is a nebulizing device for single use, commonly used in invasive and non invasive mechanical ventilation.
Nebulizer will be responsible for a salbutamol solution available in the form of containers of 2.5 ml containing 2.5 mg of salbutamol
干预措施: Airvo2 with Aerogen Solo (Device)
Mask
During nebulization in the usual way ( oral facial mask ) , it will be used a pneumatic nebulizer powered by a 6 L / min air flow rate ( usual method ).
Nebulizer will be responsible for a salbutamol solution available in the form of containers of 2.5 ml containing 2.5 mg of salbutamol
干预措施: Mask (Device)
arm control Airvo2 without nebulization of salbutamol
control procedure is to be placed under humidified high flow nasal alone
干预措施: arm control Airvo2 without nebulization of salbutamol (Device)
结局指标
主要结局
Increased expiratory volume in one second ( FEV )
时间窗: measured before and after nebulization of salbutamol at 0 minute and 15 minutes after nebulization of salbutamol
次要结局
- clinical data (FEV / FVC) on the physiological effects of high nasal flow(before and after treatment with humidified high nasal flow at 0 minute and 30 minutes after the treatment with humidified high nasal flow)
- clinical data (FVC) on the physiological effects of high nasal flow(before and after treatment with humidified high nasal flow at 0 minute and 30 minutes after the treatment with humidified high nasal flow)
- clinical data (FEV) on the physiological effects of high nasal flow(before and after treatment with humidified high nasal flow at 0 minute and 30 minutes after the treatment with humidified high nasal flow)