In Vitro Assessment of a Breath-synchronized Vibrating Mesh Nebulizer During Non Invasive Ventilation (Synchro-Neb)

University Hospital St Luc, Brussels

Status: Completed

Conditions: Asthma; Lung Diseases; Cystic Fibrosis; COPD; Respiratory Diseases

Treatments: Drug: Nebulization of Amikacin during NIV (RR: 15 cycles/minute); Drug: Nebulization of Amikacin during NIV (RR: 25 cycles/minute)

Study type: Interventional

Funder types: Other

Identifiers

NCT02084043

Synchro-Neb

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Not applicable (in vitro study)

Exclusion criteria

• hypersensitivity (allergic) reactions to aminoglycosides

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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3 participants in 2 patient groups

Breath-actuated vibrating mesh nebulizer

Experimental group

Description:

500 mg/4 mL of Amikacin solution delivered with an experimental breath-actuated vibrating mesh nebulizer associated with a single limb circuit ventilator.

Treatment:

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

Drug: Nebulization of Amikacin during NIV (RR: 15 cycles/minute)

Conventional vibrating mesh nebulizer

Experimental group

Description:

500 mg/4 mL of Amikacin solution delivered with a conventional vibrating mesh nebulizer (in continuous mode) associated with a single limb circuit ventilator.

Treatment:

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

Drug: Nebulization of Amikacin during NIV (RR: 15 cycles/minute)