Evaluation of the Effectiveness of the Nebulization Bronchodilators Under High Nasal Flow Humidified

University Hospital, Tours25 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Airvo2 with Aerogen SoloDEVICE

Nebulization of salbutamol with Airvo 2 and Aerogen solo

MaskDEVICE

Usual nebulization of salbutamol with mask

arm control Airvo2 without nebulization of salbutamolDEVICE

Airvo2 with Aerogen Solo. No nebulization of salbutamol

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Service de Réanimation Polyvalente

Tours, France

Outcomes

Primary Outcomes

Increased expiratory volume in one second ( FEV )

Time frame: measured before and after nebulization of salbutamol at 0 minute and 15 minutes after nebulization of salbutamol

Secondary Outcomes

clinical data (FVC) on the physiological effects of high nasal flow

Time frame: 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

Time frame: 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 / FVC) on the physiological effects of high nasal flow

Time frame: before and after treatment with humidified high nasal flow at 0 minute and 30 minutes after the treatment with humidified high nasal flow

Data from ClinicalTrials.gov

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