HealthyNCT02429817
Tomographic Comparison of Aerosol Lung Distribution With Two Nebulizers Through a High Flow Nasal Cannula
A study testing Technetium-99m - Diethylenetriaminepentaacetic acid, Aeroneb Solo and Jet Nebulizer in people with Healthy, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
Vibrating-mesh nebulizers ensure currently the best deposition output and are recommended in routine use in intensive care unit. However, jet nebulizers remain the most frequently used nebulizers. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Technetium-99m - Diethylenetriaminepentaacetic acid, Aeroneb Solo and Jet Nebulizer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2015to Dec 2016
- 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 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy respiratory function
Who cannot join
- Pulmonary disease
Trial locations and contacts
1 site in 1 country.
About this study
Vibrating-mesh nebulizers ensure currently the best deposition output and are recommended in routine use in intensive care unit. However, jet nebulizers remain the most frequently used nebulizers.
On a bench study, aerosol delivery through a high flow nasal cannula (HFNC) was increased using a vibrating-mesh nebulizer as compared to a jet nebulizer.
Lung distribution of nebulized particles delivered through a HFNC has never been investigated in vivo. The aim of this study was to compare aerosol lung distribution with both nebulizers through a HFNC by SPECT-CT.
- Conditions
- Healthy
- Being tested
- Technetium-99m - Diethylenetriaminepentaacetic acid, Aeroneb Solo, Jet Nebulizer, Single photon emission computed tomography, Spirometry
- Keywords
- Pulmonary aerosol distribution, SPECT-CT analysis, High flow nasal cannula, Vibrating-mesh nebulizer, Jet nebulizer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technetium-99m - Diethylenetriaminepentaacetic acidDrug
99mTc-DTPA solution placed on the nebulizer reservoir
Aeroneb SoloDevice
Jet NebulizerDevice
Single photon emission computed tomographyOther
Imaging technique to investigate lung aerosol distribution
SpirometryOther
FEV1, FVC assessment
| Study group | Role | What they receive |
|---|---|---|
| Aeroneb Solo | Active comparator | Subjects inhaled radiolabelled aerosol via the Aeroneb Solo connected to the high flow nasal cannula. Receives: Drug: Technetium-99m - Diethylenetriaminepentaacetic acid; Device: Aeroneb Solo; Other: Single photon emission computed tomography; Other: Spirometry |
| Standard Jet Nebulizer | Active comparator | Subjects inhaled radiolabelled aerosol via the jet nebulizer connected to the high flow nasal cannula. Receives: Drug: Technetium-99m - Diethylenetriaminepentaacetic acid; Device: Jet Nebulizer; Other: Single photon emission computed tomography; Other: Spirometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary deposition
Single photon emission tomography combined with a CT-scan
Measured: Immediately after nebulization by imaging technique, expected average of 15 minutes
Secondary outcomes (1)
Three-dimensional penetration index
Measured: immediately after the nebulization by imaging assessment, expected average of 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02429817
- Sponsor's protocol ID
- Aerospect-02
- Status last verified
- Dec 2016
- First submitted
- 20 Apr 2015
- Last updated
- 5 Dec 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tomographic Comparison of Aerosol Lung Distribution With Two Nebulizers Through a High Flow Nasal Cannula
- ClinicalTrials.gov ID
- NCT02429817
- Acronym / sponsor ID
- Aerospect-02
- Conditions
- Healthy
- Keywords
- Pulmonary aerosol distribution, SPECT-CT analysis, High flow nasal cannula, Vibrating-mesh nebulizer, Jet nebulizer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 29 Apr 2015 (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.
Vibrating-mesh nebulizers ensure currently the best deposition output and are recommended in routine use in intensive care unit. However, jet nebulizers remain the most frequently used nebulizers.
On a bench study, aerosol delivery through a high flow nasal cannula (HFNC) was increased using a vibrating-mesh nebulizer as compared to a jet nebulizer.
Lung distribution of nebulized particles delivered through a HFNC has never been investigated in vivo. The aim of this study was to compare aerosol lung distribution with both nebulizers through a HFNC by SPECT-CT.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aeroneb Solo | Active comparator | Drug: Technetium-99m - Diethylenetriaminepentaacetic acid, Device: Aeroneb Solo, Other: Single photon emission computed tomography, Other: SpirometrySubjects inhaled radiolabelled aerosol via the Aeroneb Solo connected to the high flow nasal cannula. |
| Standard Jet Nebulizer | Active comparator | Drug: Technetium-99m - Diethylenetriaminepentaacetic acid, Device: Jet Nebulizer, Other: Single photon emission computed tomography, Other: SpirometrySubjects inhaled radiolabelled aerosol via the jet nebulizer connected to the high flow nasal cannula. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy respiratory function
Key exclusion criteria (1 listed)
- Pulmonary disease
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 |
|---|---|---|
| Technetium-99m - Diethylenetriaminepentaacetic acid99mTc-DTPA solution placed on the nebulizer reservoir | Drug | Aeroneb Solo, Standard Jet Nebulizer |
| Aeroneb Solo | Device | Aeroneb Solo |
| Jet Nebulizer | Device | Standard Jet Nebulizer |
| Single photon emission computed tomographyImaging technique to investigate lung aerosol distribution | Other | Aeroneb Solo, Standard Jet Nebulizer |
| SpirometryFEV1, FVC assessment | Other | Aeroneb Solo, Standard Jet Nebulizer |
Primary outcome
Pulmonary deposition
Time frame: Immediately after nebulization by imaging technique, expected average of 15 minutes
Single photon emission tomography combined with a CT-scan
1 secondary outcome
Three-dimensional penetration index
Time frame: immediately after the nebulization by imaging assessment, expected average of 30 minutes
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 5 Dec 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technetium-99m - Diethylenetriaminepentaacetic acid, Aeroneb Solo and Jet Nebulizer in people with Healthy, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain 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 5 Dec 2016. 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?
Pulmonary deposition (time frame: Immediately after nebulization by imaging technique, expected average of 15 minutes). 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 5 Dec 2016.