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

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Device: Airvo2 with Aerogen Solo; Device: Mask; Device: arm control Airvo2 without nebulization of salbutamol

• Registration Number: NCT02812979
• Lead Sponsor: University Hospital, Tours

Brief Summary

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).

Detailed 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.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-16
• Study First Submitted QC: 2016-06-23
• Study First Posted: 2016-06-24
• Primary Completion: 2018-04-27
• Study Completion: 2018-04-27
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-09
• Last Update Posted: 2018-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Airvo2 with Aerogen Solo	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
Mask	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
arm control Airvo2 without nebulization of salbutamol	arm control Airvo2 without nebulization of salbutamol	control procedure is to be placed under humidified high flow nasal alone

Primary Outcome Measures

Name	Time	Method
Increased expiratory volume in one second ( FEV )	measured before and after nebulization of salbutamol at 0 minute and 15 minutes after nebulization of salbutamol

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Service de Réanimation Polyvalente; 🇫🇷 Tours, France