Evaluation of the Effectiveness of the Nebulization Bronchodilators Under High Nasal Flow Humidified
NCT ID: NCT02812979
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
25 participants
INTERVENTIONAL
2016-06-30
2018-04-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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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
Airvo2 with Aerogen Solo
Nebulization of salbutamol with Airvo 2 and Aerogen solo
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
Mask
Usual nebulization of salbutamol with mask
arm control Airvo2 without nebulization of salbutamol
control procedure is to be placed under humidified high flow nasal alone
arm control Airvo2 without nebulization of salbutamol
Airvo2 with Aerogen Solo. No nebulization of salbutamol
Interventions
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Airvo2 with Aerogen Solo
Nebulization of salbutamol with Airvo 2 and Aerogen solo
Mask
Usual nebulization of salbutamol with mask
arm control Airvo2 without nebulization of salbutamol
Airvo2 with Aerogen Solo. No nebulization of salbutamol
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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University Hospital, Tours
OTHER
Responsible Party
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Locations
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Service de Réanimation Polyvalente
Tours, , France
Countries
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References
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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.
Other Identifiers
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2016-A00064-47
Identifier Type: OTHER
Identifier Source: secondary_id
PHAO15-SE / AirvoNEB
Identifier Type: -
Identifier Source: org_study_id