Synchro-Neb: In Vitro Assessment of a Breath-synchronized Vibrating Mesh Nebulizer During Non Invasive Ventilation
Sponsor
University Hospital St Luc, Brussels (Other)
Overall Status
Completed
CT.gov ID
NCT02084043
Collaborator
Université Catholique de Louvain (Other), University of Applied Sciences of Western Switzerland (Other), School of Gestion and Engineering Vaud, Switzerland (Other)
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2
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Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
3 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
In Vitro Comparison of Continuous and Breath-synchronized Vibrating Mesh Nebulizer During Non Invasive Ventilation: Analysis of Inhaled and Lost Doses.
Study Start Date
:
Mar 1, 2014
Actual Primary Completion Date
:
Jun 1, 2015
Actual Study Completion Date
:
Jun 1, 2015
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Breath-actuated vibrating mesh nebulizer 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)
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
Other Names:
Drug: Nebulization of Amikacin during NIV (RR: 25 cycles/minute)
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
Other Names:
|
| Experimental: Conventional vibrating mesh nebulizer 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)
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
Other Names:
Drug: Nebulization of Amikacin during NIV (RR: 25 cycles/minute)
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
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Inhaled dose [after 24 hours]
The inhaled dose assessed by residual gravimetric method
Secondary Outcome Measures
- Expiratory wasted dose [after 24 hours]
The dose expelled in the ambient air through the exhalation port assessed by residual gravimetric method
Other Outcome Measures
- Estimated lost dose [after 24 hours]
The dose lost into the circuit (nebulizer included) assessed by residual gravimetric method
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- Not applicable (in vitro study)
Exclusion Criteria:
- hypersensitivity (allergic) reactions to aminoglycosides
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital St Luc | Brussels | Belgium | 1200 |
Sponsors and Collaborators
- University Hospital St Luc, Brussels
- Université Catholique de Louvain
- University of Applied Sciences of Western Switzerland
- School of Gestion and Engineering Vaud, Switzerland
Investigators
- Principal Investigator: 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)
- Study Chair: 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 Director: Gregory Reychler, PhD, Cliniques universitaires Saint-Luc, service de pneumologie
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Jean-Bernard Michotte,
MSc, PhD Student,
University of Applied Sciences of Western Switzerland
ClinicalTrials.gov Identifier:
NCT02084043
Other Study ID Numbers:
- Synchro-Neb
First Posted:
Mar 11, 2014
Last Update Posted:
Jun 8, 2015
Last Verified:
Jun 1, 2015
Keywords provided by Jean-Bernard Michotte,
MSc, PhD Student,
University of Applied Sciences of Western Switzerland
Additional relevant MeSH terms: