Brain Injuries, TraumaticAerovent-NCT03464175
Influence of Respiratory Gases Conditioning on Aerosol Delivery During Invasive Ventilation
A study testing Aerogen Solo®, Heated-humidified circuit and Dry ventilator circuit specific for aerosol therapy in people with Brain Injuries, Traumatic, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
The intention is to enroll a specific sample of intubated patients. To compare the effect of respiratory gas conditioning on lung deposition and considering the well-known influences of lung pathology on lung deposition, intubated patients with healthy lungs will be included. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injuries, Traumatic
- What is being tested?
- Aerogen Solo®, Heated-humidified circuit and Dry ventilator circuit specific for aerosol therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteBelgium
- Study dates
- 22 Jan 2018to 15 Dec 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older
- Postoperative neurosurgery intubated patients admitted for brain neurosurgery in the ICU (Intensive care neuro-traumatologic and Toxicologic)- With a healthy lung function.
- Signed and dated informed consent should be obtained in accordance of local regulations.
Who cannot join
- Spine neurosurgery
- History of cardiovascular and pulmonary disease
- Extubation immediately after surgery
- Modification of the allocated humidification technique before or during the nebulization (heated-humidifier deficiency or safety concern)
- Inaccurate quantification of aerosol deposition (i.e., artifacts or overlap of tracheal and pulmonary deposition).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Respiratory Gases Conditioning on Aerosol Delivery During Invasive Ventilation: a Randomized Comparative Scintigraphic Study
The intention is to enroll a specific sample of intubated patients. To compare the effect of respiratory gas conditioning on lung deposition and considering the well-known influences of lung pathology on lung deposition, intubated patients with healthy lungs will be included. Postoperative neurosurgery ventilated patients respond perfectly to this criteria. A previous study including 17 postoperative neurosurgery patients was performed in 2013 with a perfect collaboration between the ICU and the Department of Neurosurgery and Anesthesiology.
- Conditions
- Brain Injuries, Traumatic
- Being tested
- Aerogen Solo®, Heated-humidified circuit, Dry ventilator circuit specific for aerosol therapy, Conventional dry ventilator circuit with HME filter
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerogen Solo®Device
Aerosol particles are generated by a vibrating-mesh nebulizer specifically designed for mechanical ventilation
Heated-humidified circuitDevice
It will be left on during the transfer and the nebulization in group 1
Heated-humidified circuitDevice
It will be turned off 30 minutes before the nebulization (nebulization ended max 45 minutes after turning off the heated-humidifier).
Dry ventilator circuit specific for aerosol therapyDevice
Streamlined components, specific position for the nebulizer at 30 cm of a V-shaped Y piece
Conventional dry ventilator circuit with HME filterDevice
The nebulizer is placed between the filter and the endotracheal tube.
| Study group | Role | What they receive |
|---|---|---|
| Heated-humidifier left on during nebulization | Active comparator | Not described Receives: Device: Aerogen Solo®; Device: Heated-humidified circuit |
| Heated-humidifier turned off 30 minutes before nebulization | Active comparator | Not described Receives: Device: Aerogen Solo®; Device: Heated-humidified circuit |
| Use of a heat and moisture exchanger (HME) filter | Active comparator | Not described Receives: Device: Aerogen Solo®; Device: Conventional dry ventilator circuit with HME filter |
| Use of a dry ventilator circuit specific for aerosol therapy | Active comparator | Not described Receives: Device: Aerogen Solo®; Device: Dry ventilator circuit specific for aerosol therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantity of aerosol deposition from the nebulizer reservoir to the subject. Measured by Planar scintigraphy.
% of the nominal dose.
Measured: 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study start22 Jan 2018
- Primary completion15 Dec 2020
- Study completion15 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Injuries, TraumaticStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre-François Laterre, MD, PhD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03464175
- Sponsor's protocol ID
- 2017/08NOV/508
- Acronym
- Aerovent-
- Status last verified
- Nov 2022
- First submitted
- 4 Mar 2018
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Respiratory Gases Conditioning on Aerosol Delivery During Invasive Ventilation: a Randomized Comparative Scintigraphic Study
- ClinicalTrials.gov ID
- NCT03464175
- Acronym / sponsor ID
- Aerovent- / 2017/08NOV/508
- Conditions
- Brain Injuries, Traumatic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 22 Jan 2018 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 13 Mar 2018 (actual)
- 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.
The intention is to enroll a specific sample of intubated patients. To compare the effect of respiratory gas conditioning on lung deposition and considering the well-known influences of lung pathology on lung deposition, intubated patients with healthy lungs will be included. Postoperative neurosurgery ventilated patients respond perfectly to this criteria. A previous study including 17 postoperative neurosurgery patients was performed in 2013 with a perfect collaboration between the ICU and the Department of Neurosurgery and Anesthesiology.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Heated-humidifier left on during nebulization | Active comparator | Device: Aerogen Solo®, Device: Heated-humidified circuit |
| Heated-humidifier turned off 30 minutes before nebulization | Active comparator | Device: Aerogen Solo®, Device: Heated-humidified circuit |
| Use of a heat and moisture exchanger (HME) filter | Active comparator | Device: Aerogen Solo®, Device: Conventional dry ventilator circuit with HME filter |
| Use of a dry ventilator circuit specific for aerosol therapy | Active comparator | Device: Aerogen Solo®, Device: Dry ventilator circuit specific for aerosol therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 years or older
- Postoperative neurosurgery intubated patients admitted for brain neurosurgery in the ICU (Intensive care neuro-traumatologic and Toxicologic)- With a healthy lung function.
- Signed and dated informed consent should be obtained in accordance of local regulations.
Key exclusion criteria (5 listed)
- Spine neurosurgery
- History of cardiovascular and pulmonary disease
- Extubation immediately after surgery
- Modification of the allocated humidification technique before or during the nebulization (heated-humidifier deficiency or safety concern)
- Inaccurate quantification of aerosol deposition (i.e., artifacts or overlap of tracheal and pulmonary deposition).
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 |
|---|---|---|
| Aerogen Solo®Aerosol particles are generated by a vibrating-mesh nebulizer specifically designed for mechanical ventilation | Device | Heated-humidifier left on during nebulization, Heated-humidifier turned off 30 minutes before nebulization, Use of a dry ventilator circuit specific for aerosol therapy, Use of a heat and moisture exchanger (HME) filter |
| Heated-humidified circuitIt will be left on during the transfer and the nebulization in group 1 | Device | Heated-humidifier left on during nebulization |
| Heated-humidified circuitIt will be turned off 30 minutes before the nebulization (nebulization ended max 45 minutes after turning off the heated-humidifier). | Device | Heated-humidifier turned off 30 minutes before nebulization |
| Dry ventilator circuit specific for aerosol therapyStreamlined components, specific position for the nebulizer at 30 cm of a V-shaped Y piece | Device | Use of a dry ventilator circuit specific for aerosol therapy |
| Conventional dry ventilator circuit with HME filterThe nebulizer is placed between the filter and the endotracheal tube. | Device | Use of a heat and moisture exchanger (HME) filter |
Primary outcome
Quantity of aerosol deposition from the nebulizer reservoir to the subject. Measured by Planar scintigraphy.
Time frame: 45 minutes
% of the nominal dose.
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 4 Nov 2022.
Related trials for Brain Injuries, Traumatic
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
RecruitingObservational study
Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
Chronic Subdural Hematoma
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, MD, PhD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerogen Solo®, Heated-humidified circuit and Dry ventilator circuit specific for aerosol therapy in people with Brain Injuries, Traumatic, 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 3 inclusion and 5 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 4 Nov 2022. 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?
Quantity of aerosol deposition from the nebulizer reservoir to the subject. Measured by Planar scintigraphy. (time frame: 45 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 4 Nov 2022.