Evaluation of the Effectiveness of the Nebulization Bronchodilators Under High Nasal Flow Humidified (AirvoNEB)

Regional University Hospital Center (CHRU)

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Device: Airvo2 with Aerogen Solo; Device: Mask; Device: arm control Airvo2 without nebulization of salbutamol

Study type: Interventional

Funder types: Other

Identifiers

NCT02812979

PHAO15-SE / AirvoNEB

2016-A00064-47 (Other Identifier)

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adults

• Patient with chronic obstructive pulmonary disease

• Patients, when performing lung function tests performed outside of the study :

  1. A report FEV / FVC less than 60% prior to bronchodilator treatment AND
  2. 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

25 participants in 3 patient groups, including a placebo group

Airvo2 with Aerogen Solo

Experimental group

Description:

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

Treatment:

Device: Airvo2 with Aerogen Solo

Mask

Active Comparator group

Description:

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

Treatment:

Device: Mask

arm control Airvo2 without nebulization of salbutamol

Placebo Comparator group

Description:

control procedure is to be placed under humidified high flow nasal alone

Treatment:

Device: arm control Airvo2 without nebulization of salbutamol