Clincosm LogoSign in Get a demo

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

Sponsor
University Hospital, Tours (Other)
Overall Status
Completed
CT.gov ID
NCT02812979
Collaborator
(none)
25
Enrollment
1
Location
3
Arms
22.8
Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Device: Airvo2 with Aerogen Solo
  • Device: Mask
  • Device: arm control Airvo2 without nebulization of salbutamol
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Evaluation of the Effectiveness of the Nebulization Bronchodilators Under High Nasal Flow Humidified Compared to a Usual Method
Study Start Date :
Jun 1, 2016
Actual Primary Completion Date :
Apr 27, 2018
Actual Study Completion Date :
Apr 27, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

Device: Airvo2 with Aerogen Solo
Nebulization of salbutamol with Airvo 2 and Aerogen solo
Other Names:
  • AirvoNEB

    		•
    Active Comparator: 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

    Device: Mask
    Usual nebulization of salbutamol with mask
    Placebo Comparator: arm control Airvo2 without nebulization of salbutamol

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

    Device: arm control Airvo2 without nebulization of salbutamol
    Airvo2 with Aerogen Solo. No nebulization of salbutamol

    Outcome Measures

    Primary Outcome Measures

    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 Outcome Measures

    1. 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]

    2. 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]

    3. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Service de Réanimation Polyvalente Tours France 37044

    Sponsors and Collaborators

    • University Hospital, Tours

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Tours
    ClinicalTrials.gov Identifier:
    NCT02812979
    Other Study ID Numbers:
    • PHAO15-SE / AirvoNEB
    • 2016-A00064-47
    First Posted:
    Jun 24, 2016
    Last Update Posted:
    May 15, 2018
    Last Verified:
    May 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Lung Diseases, Obstructive
    Pulmonary Disease, Chronic Obstructive
    Albuterol

    Study Results

    No Results Posted as of May 15, 2018