In Vitro Assessment of a Breath-synchronized Vibrating Mesh Nebulizer During Non Invasive Ventilation
NCT ID: NCT02084043
Last Updated: 2015-06-08
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
3 participants
INTERVENTIONAL
2014-03-31
2015-06-30
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
NONE
Study Groups
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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.
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
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
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.
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
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
Interventions
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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
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
Yes
Sponsors
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Université Catholique de Louvain
OTHER
University of Applied Sciences of Western Switzerland
OTHER
School of Gestion and Engineering Vaud, Switzerland
UNKNOWN
University Hospital St Luc, Brussels
OTHER
Responsible Party
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Jean-Bernard Michotte
MSc, PhD Student
Principal Investigators
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Jean-Bernard Michotte, PhD student
Role: PRINCIPAL_INVESTIGATOR
University of Health Sciences (HESAV)
Jonathan Dugernier, PhD student
Role: PRINCIPAL_INVESTIGATOR
Cliniques universitaires Saint-Luc, service des soins intensifs
Enrico Staderini, PhD
Role: PRINCIPAL_INVESTIGATOR
School of Gestion and Engineering Vaud (HEIG-VD)
Rares Rusu, MSc
Role: STUDY_CHAIR
School of Gestion and Engineering Vaud (HEIG-VD)
Jean Roeseler, PhD
Role: STUDY_CHAIR
Cliniques universitaires Saint-Luc, service des soins intensifs
Giuseppe Liistro, MD PhD
Role: STUDY_CHAIR
Cliniques universitaires Saint-Luc, service de pneumologie
Gregory Reychler, PhD
Role: STUDY_DIRECTOR
Cliniques universitaires Saint-Luc, service de pneumologie
Locations
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University Hospital St Luc
Brussels, , Belgium
Countries
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Other Identifiers
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Synchro-Neb
Identifier Type: -
Identifier Source: org_study_id
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