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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02084043

Acronym

Synchro-Neb

Enrollment

Registered

2014-03-11

Start date

2014-03-31

Completion date

2015-06-30

Last updated

2015-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

aerosol delivery, vibrating mesh nebulizer, breath-actuated nebulizer, non invasive ventilation, bilevel ventilator, single limb circuit ventilator, Amikacin

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.

Interventions

DRUGNebulization 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

DRUGNebulization of Amikacin during NIV (RR: 25 cycles/minute)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

Inclusion criteria

* Not applicable (in vitro study)

Exclusion criteria

* hypersensitivity (allergic) reactions to aminoglycosides

Design outcomes

Primary

Measure	Time frame	Description
Inhaled dose	after 24 hours	The inhaled dose assessed by residual gravimetric method

Secondary

Measure	Time frame	Description
Expiratory wasted dose	after 24 hours	The dose expelled in the ambient air through the exhalation port assessed by residual gravimetric method

Other

Measure	Time frame	Description
Estimated lost dose	after 24 hours	The dose lost into the circuit (nebulizer included) assessed by residual gravimetric method

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026