Post-operative NeurosurgeryNCT02450279
Scintigraphic Comparison of Lung Deposition With Two Nebulizers During Invasive Mechanical Ventilation
A study testing technetium-99m - Diethylenetriaminepentaacetic acid, Vibrating-mesh nebulizer and Jet Nebulizer in people with Post-operative Neurosurgery, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
Many devices are available for nebulising drug solution during invasive mechanical ventilation. Vibrating-mesh nebulizers ensure the highest lung deposition output. A recent international survey on aerosol therapy during mechanical ventilation (Ehrmann et al. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Post-operative Neurosurgery
- What is being tested?
- technetium-99m - Diethylenetriaminepentaacetic acid, Vibrating-mesh nebulizer and Jet Nebulizer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2016to 7 Nov 2017
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Invasive mechanical ventilation
- Healthy lungs
Who cannot join
- Discontinued procedure due to adverse events.
Trial locations and contacts
1 site in 1 country.
About this study
Many devices are available for nebulising drug solution during invasive mechanical ventilation. Vibrating-mesh nebulizers ensure the highest lung deposition output. A recent international survey on aerosol therapy during mechanical ventilation (Ehrmann et al. 2013) reported that jet nebulizers remained the mostly used.
The aim of this study is to compare lung deposition of a radiolabeled administered with both nebulizers during invasive mechanical ventilation by planar scintigraphy.
- Conditions
- Post-operative Neurosurgery
- Being tested
- technetium-99m - Diethylenetriaminepentaacetic acid, Vibrating-mesh nebulizer, Jet Nebulizer, Planar scintigraphy, Preoperative spirometry
- Keywords
- Aerosol delivery, Invasive mechanical ventilation, Jet Nebulizer, Vibrating-Mesh nebulizer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
technetium-99m - Diethylenetriaminepentaacetic acidDrug
Vibrating-mesh nebulizerDevice
Jet NebulizerDevice
Planar scintigraphyOther
Preoperative spirometryOther
| Study group | Role | What they receive |
|---|---|---|
| Nebulization with a vibrating-mesh nebulizer | Active comparator | Nebulization performed with a vibrating-mesh nebulizer Receives: Drug: technetium-99m - Diethylenetriaminepentaacetic acid; Device: Vibrating-mesh nebulizer; Other: Planar scintigraphy; Other: Preoperative spirometry |
| Nebulization with a jet nebulizer | Active comparator | Nebulization performed with a jet nebulizer Receives: Drug: technetium-99m - Diethylenetriaminepentaacetic acid; Device: Jet Nebulizer; Other: Planar scintigraphy; Other: Preoperative spirometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary deposition
Measured: Immediately after nebulization by imaging assessment, an expected average of 30 minutes
Secondary outcomes (3)
Penetration index
Measured: Immediately after nebulization by imaging assessment, an expected average of 30 minutes
Mechanical ventilation settings
Measured: During nebulisation time, an expected average of 15 minutes
Lung function
Measured: Preoperative assessment, the day before inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2015 (estimated)
- Study startMar 2016
- Primary completion7 Nov 2017
Why it stopped: Never started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative NeurosurgeryStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre-François Laterre, Study chair, Head of Intensive Care Unit, Cliniques Universitaires Saint-Luc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02450279
- Sponsor's protocol ID
- AeroVent-02
- Status last verified
- Dec 2016
- First submitted
- 18 May 2015
- Last updated
- 8 Nov 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scintigraphic Comparison of Lung Deposition With Two Nebulizers During Invasive Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT02450279
- Acronym / sponsor ID
- AeroVent-02
- Conditions
- Post-operative Neurosurgery
- Keywords
- Aerosol delivery, Invasive mechanical ventilation, Jet Nebulizer, Vibrating-Mesh nebulizer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Never started
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- 7 Nov 2017 (actual)
- First posted
- 21 May 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.
Many devices are available for nebulising drug solution during invasive mechanical ventilation. Vibrating-mesh nebulizers ensure the highest lung deposition output. A recent international survey on aerosol therapy during mechanical ventilation (Ehrmann et al. 2013) reported that jet nebulizers remained the mostly used.
The aim of this study is to compare lung deposition of a radiolabeled administered with both nebulizers during invasive mechanical ventilation by planar scintigraphy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nebulization with a vibrating-mesh nebulizer | Active comparator | Drug: technetium-99m - Diethylenetriaminepentaacetic acid, Device: Vibrating-mesh nebulizer, Other: Planar scintigraphy, Other: Preoperative spirometryNebulization performed with a vibrating-mesh nebulizer |
| Nebulization with a jet nebulizer | Active comparator | Drug: technetium-99m - Diethylenetriaminepentaacetic acid, Device: Jet Nebulizer, Other: Planar scintigraphy, Other: Preoperative spirometryNebulization performed with a jet nebulizer |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Invasive mechanical ventilation
- Healthy lungs
Key exclusion criteria (1 listed)
- Discontinued procedure due to adverse events.
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 acid | Drug | Nebulization with a jet nebulizer, Nebulization with a vibrating-mesh nebulizer |
| Vibrating-mesh nebulizer | Device | Nebulization with a vibrating-mesh nebulizer |
| Jet Nebulizer | Device | Nebulization with a jet nebulizer |
| Planar scintigraphy | Other | Nebulization with a jet nebulizer, Nebulization with a vibrating-mesh nebulizer |
| Preoperative spirometry | Other | Nebulization with a jet nebulizer, Nebulization with a vibrating-mesh nebulizer |
Primary outcome
Pulmonary deposition
Time frame: Immediately after nebulization by imaging assessment, an expected average of 30 minutes
3 secondary outcomes
Penetration index
Time frame: Immediately after nebulization by imaging assessment, an expected average of 30 minutes
Mechanical ventilation settings
Time frame: During nebulisation time, an expected average of 15 minutes
Lung function
Time frame: Preoperative assessment, the day before inclusion
Results and safety
The study was stopped early (reason given: Never started). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2017.
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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.
Pierre-François Laterre study chair
Head of Intensive Care Unit, Cliniques Universitaires Saint-Luc
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, Vibrating-mesh nebulizer and Jet Nebulizer in people with Post-operative Neurosurgery, 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 2 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: stopped early, as of the sponsor's last update on 8 Nov 2017. 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 was stopped early (reason given: Never started). Results are not available in the source record.
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 assessment, an expected average of 30 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 8 Nov 2017.