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

NCT02812979 | Completed

• 2 other identifiers: PHAO15-SE / AirvoNEB2016-A00064-47
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• 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

Study Arms (3)

Airvo2 with Aerogen Solo

EXPERIMENTAL

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

Device: Airvo2 with Aerogen Solo

Mask

ACTIVE COMPARATOR

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

Device: Mask

arm control Airvo2 without nebulization of salbutamol

PLACEBO COMPARATOR

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

Device: arm control Airvo2 without nebulization of salbutamol

Interventions

Mask DEVICE

Usual nebulization of salbutamol with mask

Mask

Airvo2 with Aerogen Solo DEVICE

Nebulization of salbutamol with Airvo 2 and Aerogen solo

Also known as: AirvoNEB

Airvo2 with Aerogen Solo

arm control Airvo2 without nebulization of salbutamol DEVICE

Airvo2 with Aerogen Solo. No nebulization of salbutamol

arm control Airvo2 without nebulization of salbutamol

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (1)

Service de Réanimation Polyvalente

Tours, 37044, France

Location

Related Publications (1)

• Reminiac F, Vecellio L, Bodet-Contentin L, Gissot V, Le Pennec D, Salmon Gandonniere C, Cabrera M, Dequin PF, Plantier L, Ehrmann S. Nasal high-flow bronchodilator nebulization: a randomized cross-over study. Ann Intensive Care. 2018 Dec 20;8(1):128. doi: 10.1186/s13613-018-0473-8.

  PMID: 30570679 RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Masks

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Attire; Equipment and Supplies, Hospital; Equipment and Supplies; Protective Devices; Personal Protective Equipment; Surgical Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2016
• First Posted: June 24, 2016
• Study Start: June 1, 2016
• Primary Completion: April 27, 2018
• Study Completion: April 27, 2018
• Last Updated: December 22, 2025

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)