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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-A00064-47 | Other Identifier | ID RCB |
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The principal objective is to show noninferiority of nebulized salbutamol through the high flow nasal system moistened AIRVO â„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| arm control Airvo2 without nebulization of salbutamol | Placebo Comparator | control procedure is to be placed under humidified high flow nasal alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Airvo2 with Aerogen Solo | Device | Nebulization of salbutamol with Airvo 2 and Aerogen solo |
|
| Measure | Description | Time Frame |
|---|---|---|
| Increased expiratory volume in one second ( FEV ) | measured before and after nebulization of salbutamol at 0 minute and 15 minutes after nebulization of salbutamol |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
adults
Patient with chronic obstructive pulmonary disease
Patients, when performing lung function tests performed outside of the study :
Patients affiliated to social security scheme
Informed consent signed by the patient
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Réanimation Polyvalente | Tours | 37044 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30570679 | Result | 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. |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D008397 | Masks |
| ID | Term |
|---|---|
| D058257 | Surgical Attire |
| D004865 | Equipment and Supplies, Hospital |
| D004864 | Equipment and Supplies |
| D011482 | Protective Devices |
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| Mask | Device | Usual nebulization of salbutamol with mask |
|
| arm control Airvo2 without nebulization of salbutamol | Device | Airvo2 with Aerogen Solo. No nebulization of salbutamol |
|
| 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 |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000067393 | Personal Protective Equipment |
| D013523 | Surgical Equipment |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |