Post-operative NeurosurgeryNCT01879488
Effect of Ventilation Mode on Lung Deposition of a Radiolabeled Aerosol During Mechanical Ventilation: Barometric Versus Volumetric
A study testing technetium-99m - Diethylenetriaminepentaacetic acid, Vibrating-mesh nebulizer and Gamma scintigraphy in people with Post-operative Neurosurgery, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
Controlling the respiratory pattern of mechanically ventilated patients in volume control mode is recommended during nebulization. No studies looked into conditions of nebulization during assisted mechanical ventilation to define the optimal nebulization technique and its effect on pulmonary deposition. 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 Gamma scintigraphy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteBelgium
- Study dates
- Jul 2013to 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 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
- Change of ventilation mode during nebulization
Trial locations and contacts
1 site in 1 country.
About this study
Controlling the respiratory pattern of mechanically ventilated patients in volume control mode is recommended during nebulization. No studies looked into conditions of nebulization during assisted mechanical ventilation to define the optimal nebulization technique and its effect on pulmonary deposition.
The aim of this study is to analyse the effect of ventilation mode (barometric versus volumetric) on deposition by planar scintigraphy during mechanical ventilation.
- Conditions
- Post-operative Neurosurgery
- Being tested
- technetium-99m - Diethylenetriaminepentaacetic acid, Vibrating-mesh nebulizer, Gamma scintigraphy, Preoperative spirometry
- Keywords
- Aerosol, Lung deposition, Mechanical ventilation
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
Gamma scintigraphyOther
Preoperative spirometryOther
| Study group | Role | What they receive |
|---|---|---|
| Nebulization during pressure support ventilation | Active comparator | Patients ventilated in pressure support mode during nebulization Receives: Drug: technetium-99m - Diethylenetriaminepentaacetic acid; Device: Vibrating-mesh nebulizer; Other: Gamma scintigraphy; Other: Preoperative spirometry |
| Nebulization during volume assist control mode | Active comparator | Patients ventilated in volume assist control mode during nebulization Receives: Drug: technetium-99m - Diethylenetriaminepentaacetic acid; Device: Vibrating-mesh nebulizer; Other: Gamma 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 posted17 Jun 2013 (estimated)
- Study startJul 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 19 participants (actual)
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
- NCT01879488
- Sponsor's protocol ID
- AeroVent-01
- Status last verified
- Nov 2015
- First submitted
- 10 Jun 2013
- Last updated
- 17 Nov 2015
- Results posted
- No
Publications
Dugernier J, Reychler G, Wittebole X, Roeseler J, Depoortere V, Sottiaux T, Michotte JB, Vanbever R, Dugernier T, Goffette P, Docquier MA, Raftopoulos C, Hantson P, Jamar F, Laterre PF. Aerosol delivery with two ventilation modes during mechanical ventilation: a randomized study. Ann Intensive Care. 2016 Dec;6(1):73. doi: 10.1186/s13613-016-0169-x. Epub 2016 Jul 22.
PubMed 27447788
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ventilation Mode on Lung Deposition of a Radiolabeled Aerosol During Mechanical Ventilation: Barometric Versus Volumetric
- ClinicalTrials.gov ID
- NCT01879488
- Acronym / sponsor ID
- AeroVent-01
- Conditions
- Post-operative Neurosurgery
- Keywords
- Aerosol, Lung deposition, Mechanical ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 17 Jun 2013 (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.
Controlling the respiratory pattern of mechanically ventilated patients in volume control mode is recommended during nebulization. No studies looked into conditions of nebulization during assisted mechanical ventilation to define the optimal nebulization technique and its effect on pulmonary deposition.
The aim of this study is to analyse the effect of ventilation mode (barometric versus volumetric) on deposition by planar scintigraphy during mechanical ventilation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nebulization during pressure support ventilation | Active comparator | Drug: technetium-99m - Diethylenetriaminepentaacetic acid, Device: Vibrating-mesh nebulizer, Other: Gamma scintigraphy, Other: Preoperative spirometryPatients ventilated in pressure support mode during nebulization |
| Nebulization during volume assist control mode | Active comparator | Drug: technetium-99m - Diethylenetriaminepentaacetic acid, Device: Vibrating-mesh nebulizer, Other: Gamma scintigraphy, Other: Preoperative spirometryPatients ventilated in volume assist control mode during nebulization |
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)
- Change of ventilation mode during nebulization
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 during pressure support ventilation, Nebulization during volume assist control mode |
| Vibrating-mesh nebulizer | Device | Nebulization during pressure support ventilation, Nebulization during volume assist control mode |
| Gamma scintigraphy | Other | Nebulization during pressure support ventilation, Nebulization during volume assist control mode |
| Preoperative spirometry | Other | Nebulization during pressure support ventilation, Nebulization during volume assist control mode |
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 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 17 Nov 2015.
- Derived from this study: PubMed 27447788Dugernier J, Reychler G, Wittebole X, Roeseler J, Depoortere V, Sottiaux T, Michotte JB, Vanbever R, Dugernier T, Goffette P, Docquier MA, Raftopoulos C, Hantson P, Jamar F, Laterre PF. Aerosol delivery with two ventilation modes during mechanical ventilation: a randomized study. Ann Intensive Care. 2016 Dec;6(1):73. doi: 10.1186/s13613-016-0169-x. Epub 2016 Jul 22.
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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 Gamma scintigraphy 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: finished, as of the sponsor's last update on 17 Nov 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?
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?
On the ClinicalTrials.gov record for NCT01879488, which also lists 1 linked publication.
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 17 Nov 2015.