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

Primary Purpose

Respiratory Diseases, Lung Diseases, Cystic Fibrosis

Status

Completed

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

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

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

About this trial

This is an interventional treatment trial for Respiratory Diseases focused on measuring aerosol delivery, vibrating mesh nebulizer, breath-actuated nebulizer, non invasive ventilation, bilevel ventilator, single limb circuit ventilator, Amikacin

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Not applicable (in vitro study)

Exclusion Criteria:

hypersensitivity (allergic) reactions to aminoglycosides

Sites / Locations

University Hospital St Luc

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Breath-actuated vibrating mesh nebulizer

Conventional vibrating mesh nebulizer

Arm Description

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

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

Outcomes

Primary Outcome Measures

Inhaled dose

The inhaled dose assessed by residual gravimetric method

Secondary Outcome Measures

Expiratory wasted dose

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

Full Information

NCT ID

NCT02084043

First Posted

March 8, 2014

Last Updated

June 5, 2015

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

1. Study Identification

Unique Protocol Identification Number

NCT02084043

Brief Title

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

Acronym

Synchro-Neb

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Completed

Study Start Date

March 2014 (undefined)

Primary Completion Date

June 2015 (Actual)

Study Completion Date

June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the 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

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Breath-actuated vibrating mesh nebulizer

Arm Type

Experimental

Arm Description

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

Arm Title

Conventional vibrating mesh nebulizer

Arm Type

Experimental

Arm 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.

Intervention Type

Drug

Intervention Name(s)

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

Other Intervention Name(s)

Amikacine sulfate

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

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

Other Intervention Name(s)

Amikacine sulfate

Intervention Description

Primary Outcome Measure Information:

Title

Inhaled dose

Description

The inhaled dose assessed by residual gravimetric method

Time Frame

after 24 hours

Secondary Outcome Measure Information:

Title

Expiratory wasted dose

Description

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

Time Frame

after 24 hours

Other Pre-specified Outcome Measures:

Title

Estimated lost dose

Description

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

Time Frame

after 24 hours

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Not applicable (in vitro study) Exclusion Criteria: hypersensitivity (allergic) reactions to aminoglycosides

Overall Study Officials: