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

Asthma Clinical Trial

— Synchro-Neb  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02084043
• Other study ID #: Synchro-Neb
• Status: Completed
• Phase: N/A
• First received: March 8, 2014
• Last updated: June 5, 2015
• Start date: March 2014
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: University Hospital St Luc, Brussels
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Not applicable (in vitro study)

Exclusion Criteria:

• hypersensitivity (allergic) reactions to aminoglycosides

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• COPD
• Cystic Fibrosis
• Lung Diseases
• Respiration Disorders
• Respiratory Diseases
• Respiratory Tract Diseases

Intervention

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
• 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

Locations

Country	Name	City	State
Belgium	University Hospital St Luc	Brussels

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital St Luc, Brussels	School of Gestion and Engineering Vaud, Switzerland, Université Catholique de Louvain, University of Applied Sciences of Western Switzerland

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Estimated lost dose	The dose lost into the circuit (nebulizer included) assessed by residual gravimetric method	after 24 hours	No
Primary	Inhaled dose	The inhaled dose assessed by residual gravimetric method	after 24 hours	No
Secondary	Expiratory wasted dose	The dose expelled in the ambient air through the exhalation port assessed by residual gravimetric method	after 24 hours	No