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Completed

NCT Number: NCT02084043

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

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.

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Key information

Conditions

Respiratory Diseases Asthma Bronchial Diseases COPD Chronic Disease Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Digestive System Diseases Disease Attributes Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infant, Newborn, Diseases Lung Diseases Lung Diseases, Obstructive Pancreatic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital St Luc

Brussels, 1200, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Not applicable (in vitro study)

Exclusion criteria

  • hypersensitivity (allergic) reactions to aminoglycosides

Treatment and study plan

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

Drug

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

Other names: Amikacine sulfate

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

Drug

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 names: Amikacine sulfate

Primary outcomes

  1. Inhaled dose

    Time frame: after 24 hours

    The inhaled dose assessed by residual gravimetric method

Secondary outcomes

  1. Expiratory wasted dose

    Time frame: after 24 hours

    The dose expelled in the ambient air through the exhalation port assessed by residual gravimetric method

Other outcomes

  1. Estimated lost dose

    Time frame: after 24 hours

    The dose lost into the circuit (nebulizer included) assessed by residual gravimetric method

Sponsors and collaborators

Lead sponsor

University Hospital St Luc, Brussels

Other

Collaborators

  • School of Gestion and Engineering Vaud, Switzerland
  • University of Applied Sciences of Western Switzerland
  • Université Catholique de Louvain

Registry information

Official study title

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

Acronym: Synchro-Neb

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 11, 2014
Registry last updated
Jun 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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