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| Name | Class |
|---|---|
| Université Catholique de Louvain | OTHER |
| University of Applied Sciences of Western Switzerland | OTHER |
| School of Gestion and Engineering Vaud, Switzerland | UNKNOWN |
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Using an adult lung bench model of non invasive ventilation, the aim of the study is to compare an experimental system of breath-synchronized vibrating mesh nebulizer to a conventional vibrating mesh nebulizer during non invasive ventilation in terms of inhaled and lost doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breath-actuated vibrating mesh nebulizer | Experimental | 500 mg/4 mL of Amikacin solution delivered with an experimental breath-actuated vibrating mesh nebulizer associated with a single limb circuit ventilator. |
|
| Conventional vibrating mesh nebulizer | Experimental | 500 mg/4 mL of Amikacin solution delivered with a conventional vibrating mesh nebulizer (in continuous mode) associated with a single limb circuit ventilator. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nebulization of Amikacin during NIV (RR: 15 cycles/minute) | Drug | 500 mg/4 mL Amikacin nebulized using vibrating mesh nebulizer associated with a single limb bilevel ventilator. The nebulizations are considered as finished when there is no visible evidence of nebulization for a period of 30 seconds. The NIV is set with an IPAP of 15 cmH2O and EPAP of 5 cmH2O. The lung model is simulated with a respiratory rate of 15 cycles/minute |
| Measure | Description | Time Frame |
|---|---|---|
| Inhaled dose | The inhaled dose assessed by residual gravimetric method | after 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Expiratory wasted dose | The dose expelled in the ambient air through the exhalation port assessed by residual gravimetric method | after 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Estimated lost dose | The dose lost into the circuit (nebulizer included) assessed by residual gravimetric method | after 24 hours |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Bernard Michotte, PhD student | University of Health Sciences (HESAV) | Principal Investigator |
| Jonathan Dugernier, PhD student | Cliniques universitaires Saint-Luc, service des soins intensifs | Principal Investigator |
| Enrico Staderini, PhD | School of Gestion and Engineering Vaud (HEIG-VD) | Principal Investigator |
| Rares Rusu, MSc | School of Gestion and Engineering Vaud (HEIG-VD) | Study Chair |
| Jean Roeseler, PhD | Cliniques universitaires Saint-Luc, service des soins intensifs | Study Chair |
| Giuseppe Liistro, MD PhD | Cliniques universitaires Saint-Luc, service de pneumologie | Study Chair |
| Gregory Reychler, PhD | Cliniques universitaires Saint-Luc, service de pneumologie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital St Luc | Brussels | 1200 | Belgium |
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|
| Nebulization of Amikacin during NIV (RR: 25 cycles/minute) | Drug | 500 mg/4 mL Amikacin nebulized using vibrating mesh nebulizer associated with a single limb bilevel ventilator. The nebulizations are considered as finished when there is no visible evidence of nebulization for a period of 30 seconds. The NIV is set with an IPAP of 15 cmH2O and EPAP of 5 cmH2O. The lung model is simulated with a respiratory rate of 25 cycles/minute |
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|
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D008171 | Lung Diseases |
| D003550 | Cystic Fibrosis |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D001249 | Asthma |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D008173 | Lung Diseases, Obstructive |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001982 | Bronchial Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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