In Vitro Assessment of a Breath-synchronized Vibrating Mesh Nebulizer During Non Invasive Ventilation

Study Overview
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Brief Summary
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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.

Official Title
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In Vitro Comparison of Continuous and Breath-synchronized Vibrating Mesh Nebulizer During Non Invasive Ventilation: Analysis of Inhaled and Lost Doses.

Conditions
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Asthma, Respiratory Diseases, Lung Diseases, Cystic Fibrosis, COPD

Intervention / Treatment
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* Drug: Nebulization of Amikacin during NIV (RR: 15 cycles/minute)
* Drug: Nebulization of Amikacin during NIV (RR: 25 cycles/minute)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Not applicable (in vitro study) Exclusion Criteria: hypersensitivity (allergic) reactions to aminoglycosides
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Breath-actuated vibrating mesh nebulizer<br>500 mg/4 mL of Amikacin solution delivered with an experimental breath-actuated vibrating mesh nebulizer associated with a single limb circuit ventilator. | Drug: Nebulization of Amikacin during NIV (RR: 15 cycles/minute)<br>* 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<br>* Other names: Amikacine sulfate;Drug: Nebulization of Amikacin during NIV (RR: 25 cycles/minute)<br>* 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<br>* Other names: Amikacine sulfate;|
| Experimental: Conventional vibrating mesh nebulizer<br>500 mg/4 mL of Amikacin solution delivered with a conventional vibrating mesh nebulizer (in continuous mode) associated with a single limb circuit ventilator. | Drug: Nebulization of Amikacin during NIV (RR: 15 cycles/minute)<br>* 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<br>* Other names: Amikacine sulfate;Drug: Nebulization of Amikacin during NIV (RR: 25 cycles/minute)<br>* 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<br>* Other names: Amikacine sulfate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inhaled dose | The inhaled dose assessed by residual gravimetric method | after 24 hours | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aerosol delivery, vibrating mesh nebulizer, breath-actuated nebulizer, non invasive ventilation, bilevel ventilator, single limb circuit ventilator, Amikacin