Respiratory DiseasesSynchro-NebNCT02084043
In Vitro Assessment of a Breath-synchronized Vibrating Mesh Nebulizer During Non Invasive Ventilation
A study testing Nebulization of Amikacin during NIV (RR: 15 cycles/minute) and Nebulization of Amikacin during NIV (RR: 25 cycles/minute) in people with Respiratory Diseases and Lung Diseases, run by University Hospital St Luc, Brussels at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Respiratory Diseases, Lung Diseases, Cystic Fibrosis
- What is being tested?
- Nebulization of Amikacin during NIV (RR: 15 cycles/minute) and Nebulization of Amikacin during NIV (RR: 25 cycles/minute)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2014to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Not applicable (in vitro study)
Who cannot join
- hypersensitivity (allergic) reactions to aminoglycosides
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Respiratory Diseases, Lung Diseases, Cystic Fibrosis, COPD, Asthma
- Being tested
- Nebulization of Amikacin during NIV (RR: 15 cycles/minute), Nebulization of Amikacin during NIV (RR: 25 cycles/minute)
- Keywords
- aerosol delivery, vibrating mesh nebulizer, breath-actuated nebulizer, non invasive ventilation, bilevel ventilator, single limb circuit ventilator, Amikacin
- Medical subject headings
- Respiratory Tract Diseases, Lung Diseases, Cystic Fibrosis, Pulmonary Disease, Chronic Obstructive, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nebulization of Amikacin during NIV (RR: 15 cycles/minute)Drug
Also called Amikacine sulfate
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
Nebulization of Amikacin during NIV (RR: 25 cycles/minute)Drug
Also called Amikacine sulfate
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Nebulization of Amikacin during NIV (RR: 15 cycles/minute); Drug: Nebulization of Amikacin during NIV (RR: 25 cycles/minute) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inhaled dose
The inhaled dose assessed by residual gravimetric method
Measured: after 24 hours
Secondary outcomes (1)
Expiratory wasted dose
The dose expelled in the ambient air through the exhalation port assessed by residual gravimetric method
Measured: after 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital St Luc, Brussels
- Sponsor type
- University, hospital or other
- Collaborators
- Université Catholique de Louvain, University of Applied Sciences of Western Switzerland, School of Gestion and Engineering Vaud, Switzerland
- Responsible party
- Principal investigator, Jean-Bernard Michotte, University of Applied Sciences of Western Switzerland
- Investigators
- Jean-Bernard Michotte, PhD student, Principal investigator, University of Health Sciences (HESAV)Jonathan Dugernier, PhD student, Principal investigator, Cliniques universitaires Saint-Luc, service des soins intensifsEnrico Staderini, PhD, Principal investigator, School of Gestion and Engineering Vaud (HEIG-VD)Rares Rusu, MSc, Study chair, School of Gestion and Engineering Vaud (HEIG-VD)Jean Roeseler, PhD, Study chair, Cliniques universitaires Saint-Luc, service des soins intensifsGiuseppe Liistro, MD PhD, Study chair, Cliniques universitaires Saint-Luc, service de pneumologieGregory Reychler, PhD, Study director, Cliniques universitaires Saint-Luc, service de pneumologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02084043
- Sponsor's protocol ID
- Synchro-Neb
- Acronym
- Synchro-Neb
- Status last verified
- Jun 2015
- First submitted
- 8 Mar 2014
- Last updated
- 8 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vitro Comparison of Continuous and Breath-synchronized Vibrating Mesh Nebulizer During Non Invasive Ventilation: Analysis of Inhaled and Lost Doses.
- ClinicalTrials.gov ID
- NCT02084043
- Acronym / sponsor ID
- Synchro-Neb / Synchro-Neb
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University Hospital St Luc, BrusselsUniversity, hospital or other
- Collaborators
- Université Catholique de Louvain, University of Applied Sciences of Western Switzerland, School of Gestion and Engineering Vaud, Switzerland
- Study start
- Mar 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 11 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breath-actuated vibrating mesh nebulizer | Experimental | Drug: Nebulization of Amikacin during NIV (RR: 15 cycles/minute), Drug: Nebulization of Amikacin during NIV (RR: 25 cycles/minute)500 mg/4 mL of Amikacin solution delivered with an experimental breath-actuated vibrating mesh nebulizer associated with a single limb circuit ventilator. |
| Conventional vibrating mesh nebulizer | Experimental | Drug: Nebulization of Amikacin during NIV (RR: 15 cycles/minute), Drug: Nebulization of Amikacin during NIV (RR: 25 cycles/minute)500 mg/4 mL of Amikacin solution delivered with a conventional vibrating mesh nebulizer (in continuous mode) associated with a single limb circuit ventilator. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Not applicable (in vitro study)
Key exclusion criteria (1 listed)
- hypersensitivity (allergic) reactions to aminoglycosides
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nebulization of Amikacin during NIV (RR: 15 cycles/minute)Also: Amikacine sulfate500 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 | Breath-actuated vibrating mesh nebulizer, Conventional vibrating mesh nebulizer |
| Nebulization of Amikacin during NIV (RR: 25 cycles/minute)Also: Amikacine sulfate500 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 | Drug | Breath-actuated vibrating mesh nebulizer, Conventional vibrating mesh nebulizer |
Primary outcome
Inhaled dose
Time frame: after 24 hours
The inhaled dose assessed by residual gravimetric method
1 secondary outcome
Expiratory wasted dose
Time frame: after 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Bernard Michotte, PhD student principal investigator
University of Health Sciences (HESAV)
Jonathan Dugernier, PhD student principal investigator
Cliniques universitaires Saint-Luc, service des soins intensifs
Enrico Staderini, PhD principal investigator
School of Gestion and Engineering Vaud (HEIG-VD)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nebulization of Amikacin during NIV (RR: 15 cycles/minute) and Nebulization of Amikacin during NIV (RR: 25 cycles/minute) in people with Respiratory Diseases and Lung Diseases, run by University Hospital St Luc, Brussels at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inhaled dose (time frame: after 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2015.