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

June 5, 2015 updated by: Jean-Bernard Michotte, University Hospital St Luc, Brussels

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • University Hospital St Luc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Not applicable (in vitro study)

Exclusion Criteria:

  • hypersensitivity (allergic) reactions to aminoglycosides

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Breath-actuated vibrating mesh nebulizer
500 mg/4 mL of Amikacin solution delivered with an experimental breath-actuated vibrating mesh nebulizer associated with a single limb circuit ventilator.
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
Other Names:
  • Amikacine sulfate
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
Other Names:
  • Amikacine sulfate
EXPERIMENTAL: Conventional vibrating mesh nebulizer
500 mg/4 mL of Amikacin solution delivered with a conventional vibrating mesh nebulizer (in continuous mode) associated with a single limb circuit ventilator.
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
Other Names:
  • Amikacine sulfate
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
Other Names:
  • Amikacine sulfate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inhaled dose
Time Frame: after 24 hours
The inhaled dose assessed by residual gravimetric method
after 24 hours

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital St Luc, Brussels

Collaborators

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

Investigators

  • Principal Investigator: Jean-Bernard Michotte, PhD student, University of Health Sciences (HESAV)
  • Principal Investigator: Jonathan Dugernier, PhD student, Cliniques universitaires Saint-Luc, service des soins intensifs
  • Principal Investigator: Enrico Staderini, PhD, School of Gestion and Engineering Vaud (HEIG-VD)
  • Study Chair: Rares Rusu, MSc, School of Gestion and Engineering Vaud (HEIG-VD)
  • Study Chair: Jean Roeseler, PhD, Cliniques universitaires Saint-Luc, service des soins intensifs
  • Study Chair: Giuseppe Liistro, MD PhD, Cliniques universitaires Saint-Luc, service de pneumologie
  • Study Director: Gregory Reychler, PhD, Cliniques universitaires Saint-Luc, service de pneumologie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (ACTUAL)

June 1, 2015

Study Completion (ACTUAL)

June 1, 2015

Study Registration Dates

First Submitted

March 8, 2014

First Submitted That Met QC Criteria

March 8, 2014

First Posted (ESTIMATE)

March 11, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

June 8, 2015

Last Update Submitted That Met QC Criteria

June 5, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Synchro-Neb

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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