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

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.

Conditions

• Respiratory Diseases
• Lung Diseases
• Cystic Fibrosis
• COPD
• Asthma

Interventions

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

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

Sponsors & Collaborators

• Université Catholique de Louvain

  collaborator OTHER

• University of Applied Sciences of Western Switzerland

  collaborator OTHER

• School of Gestion and Engineering Vaud, Switzerland

  collaborator UNKNOWN

• University Hospital St Luc, Brussels

  lead OTHER

Principal Investigators

• Jean-Bernard Michotte, PhD student · University of Health Sciences (HESAV)

• Jonathan Dugernier, PhD student · Cliniques universitaires Saint-Luc, service des soins intensifs

• Enrico Staderini, PhD · School of Gestion and Engineering Vaud (HEIG-VD)

• Rares Rusu, MSc · School of Gestion and Engineering Vaud (HEIG-VD)

• Jean Roeseler, PhD · Cliniques universitaires Saint-Luc, service des soins intensifs

• Giuseppe Liistro, MD PhD · Cliniques universitaires Saint-Luc, service de pneumologie

• Gregory Reychler, PhD · Cliniques universitaires Saint-Luc, service de pneumologie

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-03-31

Primary Completion

2015-06-30

Completion

2015-06-30

Countries

• Belgium

Study Locations