NCT02084043

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

March 8, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 11, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

June 8, 2015

Status Verified

June 1, 2015

Enrollment Period

1.3 years

First QC Date

March 8, 2014

Last Update Submit

June 5, 2015

Conditions

Respiratory DiseasesLung DiseasesCystic FibrosisCOPDAsthma

Keywords

aerosol deliveryvibrating mesh nebulizerbreath-actuated nebulizernon invasive ventilationbilevel ventilatorsingle limb circuit ventilatorAmikacin

Outcome Measures

Primary Outcomes (1)

  • Inhaled dose

    The inhaled dose assessed by residual gravimetric method

    after 24 hours

Secondary Outcomes (1)

  • Expiratory wasted dose

    after 24 hours

Other Outcomes (1)

  • Estimated lost dose

    after 24 hours

Study Arms (2)

Breath-actuated vibrating mesh nebulizer

EXPERIMENTAL

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

Conventional vibrating mesh nebulizer

EXPERIMENTAL

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

Interventions

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

Also known as: Amikacine sulfate
Breath-actuated vibrating mesh nebulizerConventional vibrating mesh nebulizer
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

Also known as: Amikacine sulfate
Breath-actuated vibrating mesh nebulizerConventional vibrating mesh nebulizer

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Not applicable (in vitro study)

You may not qualify if:

  • hypersensitivity (allergic) reactions to aminoglycosides

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital St Luc

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Respiratory Tract DiseasesLung DiseasesCystic FibrosisPulmonary Disease, Chronic ObstructiveAsthma

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesLung Diseases, ObstructiveChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBronchial DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • 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)

    PRINCIPAL INVESTIGATOR

  • 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 CHAIR

  • Gregory Reychler, PhD

    Cliniques universitaires Saint-Luc, service de pneumologie

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc, PhD Student

Study Record Dates

First Submitted

March 8, 2014

First Posted

March 11, 2014

Study Start

March 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

June 8, 2015

Record last verified: 2015-06

Locations

BE(1)