ARDSPERVE-ARDSNCT02510105
Tomodensitometric Study of Pulmonary Effects of Intrapulmonary Percussive Ventilation in ARDS Patients
A study testing VDR4 ventilator (Intrapulmonary Percussive Ventilation), CT scan and Servo-i in people with ARDS, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The study is intended to elucidate the pulmonary effects of Intrapulmonary Percussive Ventilation (IPV) with VDR4 ventilator of patients with ARDS, using computed tomography (CT). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- ARDS
- What is being tested?
- VDR4 ventilator (Intrapulmonary Percussive Ventilation), CT scan and Servo-i
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2015to Dec 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ventilated more than 48 h
- Sedated patients
- ARDS moderate or severe (Berlin 2012)
- Patients who have given their consent or his family
- Patients aged between 18 and 85 years
Who cannot join
- Pregnant ou lactating women
- Hemodynamic instability
- Chronic respiratory insufficiency.
- Pneumothorax
- Fistulae bronchopleural
Trial locations and contacts
1 site in 1 country.
France1 site
CHU de Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
Jean-Michel CONSTANTIN
About this study
The study is intended to elucidate the pulmonary effects of Intrapulmonary Percussive Ventilation (IPV) with VDR4 ventilator of patients with ARDS, using computed tomography (CT).
Read the detailed description
Prospective clinical study in ICU of ventilated patients with ARDS. The morphologic pulmonary effects of IPV with VDR4 are not known to the investigators' knowledge.
The main aim is to quantify recruited, normally aerated and overinflated parts of the lungs after a 1 hour treatment with IPV.
Patients with ARDS (focal and non focal) consecutively admitted to the investigators' ICU are enrolled after informed consent.
Patients are intubated and ventilated with Servo-I (GE) and ventilation is optimized according to ARDS-network recommandations.
A first thoracic CT-scan is performed with ICU ventilator and then the patient is ventilated with VDR4 during 1 hour.
A second thoracic CT-scan is then performed and the patient re-ventilated with ICU ventilator.
Arterial blood gases and hemodynamic parameters are recorded during experiments.
CT-scan are analysed and compared for normally aerated, overinflated and recruited lung parenchyma. Regions are determined thanks to their Hounsfield units (HU).
- Conditions
- ARDS
- Being tested
- VDR4 ventilator (Intrapulmonary Percussive Ventilation), CT scan, Servo-i, - Intubation, Ventilation ( with an ICU conventional ventilator)
- Keywords
- Critical Care, ARDS, Intrapulmonary Percussive Ventilation, VDR4, Lung aeration, CT scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VDR4 ventilator (Intrapulmonary Percussive Ventilation)Device
CT scanDevice
Servo-iDevice
- IntubationDevice
Ventilation ( with an ICU conventional ventilator)Device
| Study group | Role | What they receive |
|---|---|---|
| ARDS patients | Experimental | Not described Receives: Device: VDR4 ventilator (Intrapulmonary Percussive Ventilation); Device: CT scan; Device: Servo-i; Device: - Intubation; Device: Ventilation ( with an ICU conventional ventilator) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline (H0) in volume of overinflated lung at H1
Measured: at Hour 0(just before Intrapulmonary Percussive Ventilation) and Hour 1(just after Intrapulmonary Percussive Ventilation)
Secondary outcomes (6)
Volume of normally aerated lung
Measured: at Hour 0 (just before Intrapulmonary Percussive Ventilation ) and Hour 1 (just after Intrapulmonary Percussive Ventilation)
Volume of recruited lung
Measured: at day 1 (between H0 and H1)
Heart rate
Measured: at day 1 ((every 10 min between H0 and H1)
Blood pressure
Measured: at day 1 (every 10 min between H0 and H1)
Arterial blood gaz
Measured: at day 1 ((every 10 min between H0 and H1)
Evolution of catecholamine doses (µg/Kg/min)
Measured: at day 1 (every 10 min between H0 and H1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
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 ARDSStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Estaing
- Responsible party
- Sponsor
- Investigators
- Jean-Michel CONSTANTIN, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02510105
- Sponsor's protocol ID
- CHU-0236
- Acronym
- PERVE-ARDS
- Status last verified
- Jul 2015
- First submitted
- 1 Jun 2015
- Last updated
- 28 Jul 2015
- Results posted
- No
Publications
Godet T, Jabaudon M, Blondonnet R, Tremblay A, Audard J, Rieu B, Pereira B, Garcier JM, Futier E, Constantin JM. High frequency percussive ventilation increases alveolar recruitment in early acute respiratory distress syndrome: an experimental, physiological and CT scan study. Crit Care. 2018 Jan 11;22(1):3. doi: 10.1186/s13054-017-1924-6.
PubMed 29325586
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tomodensitometric Study of Pulmonary Effects of Intrapulmonary Percussive Ventilation in ARDS Patients
- ClinicalTrials.gov ID
- NCT02510105
- Acronym / sponsor ID
- PERVE-ARDS / CHU-0236
- Conditions
- ARDS
- Keywords
- Critical Care, ARDS, Intrapulmonary Percussive Ventilation, VDR4, Lung aeration, CT scan
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- University Hospital, Estaing
- Study start
- Jul 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 28 Jul 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.
The study is intended to elucidate the pulmonary effects of Intrapulmonary Percussive Ventilation (IPV) with VDR4 ventilator of patients with ARDS, using computed tomography (CT).
Detailed description
Prospective clinical study in ICU of ventilated patients with ARDS. The morphologic pulmonary effects of IPV with VDR4 are not known to the investigators' knowledge.
The main aim is to quantify recruited, normally aerated and overinflated parts of the lungs after a 1 hour treatment with IPV.
Patients with ARDS (focal and non focal) consecutively admitted to the investigators' ICU are enrolled after informed consent.
Patients are intubated and ventilated with Servo-I (GE) and ventilation is optimized according to ARDS-network recommandations.
A first thoracic CT-scan is performed with ICU ventilator and then the patient is ventilated with VDR4 during 1 hour.
A second thoracic CT-scan is then performed and the patient re-ventilated with ICU ventilator.
Arterial blood gases and hemodynamic parameters are recorded during experiments.
CT-scan are analysed and compared for normally aerated, overinflated and recruited lung parenchyma. Regions are determined thanks to their Hounsfield units (HU).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARDS patients | Experimental | Device: VDR4 ventilator (Intrapulmonary Percussive Ventilation), Device: CT scan, Device: Servo-i, Device: - Intubation, Device: Ventilation ( with an ICU conventional ventilator) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients ventilated more than 48 h
- Sedated patients
- ARDS moderate or severe (Berlin 2012)
- Patients who have given their consent or his family
- Patients aged between 18 and 85 years
Key exclusion criteria (5 listed)
- Pregnant ou lactating women
- Hemodynamic instability
- Chronic respiratory insufficiency.
- Pneumothorax
- Fistulae bronchopleural
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 |
|---|---|---|
| VDR4 ventilator (Intrapulmonary Percussive Ventilation) | Device | ARDS patients |
| CT scan | Device | ARDS patients |
| Servo-i | Device | ARDS patients |
| - Intubation | Device | ARDS patients |
| Ventilation ( with an ICU conventional ventilator) | Device | ARDS patients |
Primary outcome
Change from baseline (H0) in volume of overinflated lung at H1
Time frame: at Hour 0(just before Intrapulmonary Percussive Ventilation) and Hour 1(just after Intrapulmonary Percussive Ventilation)
6 secondary outcomes
Volume of normally aerated lung
Time frame: at Hour 0 (just before Intrapulmonary Percussive Ventilation ) and Hour 1 (just after Intrapulmonary Percussive Ventilation)
Volume of recruited lung
Time frame: at day 1 (between H0 and H1)
Heart rate
Time frame: at day 1 ((every 10 min between H0 and H1)
Blood pressure
Time frame: at day 1 (every 10 min between H0 and H1)
Arterial blood gaz
Time frame: at day 1 ((every 10 min between H0 and H1)
Evolution of catecholamine doses (µg/Kg/min)
Time frame: at day 1 (every 10 min between H0 and H1)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2015.
- Derived from this study: PubMed 29325586Godet T, Jabaudon M, Blondonnet R, Tremblay A, Audard J, Rieu B, Pereira B, Garcier JM, Futier E, Constantin JM. High frequency percussive ventilation increases alveolar recruitment in early acute respiratory distress syndrome: an experimental, physiological and CT scan study. Crit Care. 2018 Jan 11;22(1):3. doi: 10.1186/s13054-017-1924-6.
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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-Michel CONSTANTIN principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VDR4 ventilator (Intrapulmonary Percussive Ventilation), CT scan and Servo-i in people with ARDS, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 5 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: status not confirmed, as of the sponsor's last update on 28 Jul 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline (H0) in volume of overinflated lung at H1 (time frame: at Hour 0(just before Intrapulmonary Percussive Ventilation) and Hour 1(just after Intrapulmonary Percussive Ventilation)). 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 NCT02510105, 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 28 Jul 2015.