Chronic Obstructive Pulmonary DiseaseIPVNCT01671540
Effects of IPV Assessed With Functional Imaging
A study testing intrapulmonary percussive ventilation and standard treatment in people with Chronic Obstructive Pulmonary Disease, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
In this study the invetigators seek an answer on the following hypothesis: What are the long term effects of an IPV treatment evaluated with classical outcome parameters? (FEV1, Raw) Is the possible effect noticeable on the novel technique and is this comparable with the classical outcome parameters? Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- intrapulmonary percussive ventilation and standard treatment
- 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
- Sep 2011to 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted in the hospital for a acute exacerbation
- Mild to severe COPD
Who cannot join
- Ischemic / ventricular aritmic
- Tracheotomise
- Pneumothorax
- Facial deformity
- Recent nose, mouth or ear operations
- Recent gastric operations.
- Intubated
- Epilepsy
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
University Hospital Antwerp
Edegem, Antwerp, 2650
Kris Ides, Msc, 038213447 ext. 0032, kris.ides@artesis.be
Wilfried De Backer, Phd
About this study
Official title: Evaluation of the Effects of Intrapulmonary Percussive Ventilation Using Functional Respiratory Imaging
In this study the invetigators seek an answer on the following hypothesis:
- What are the long term effects of an IPV treatment evaluated with classical outcome parameters? (FEV1, Raw)
- Is the possible effect noticeable on the novel technique and is this comparable with the classical outcome parameters?
Read the detailed description
A Multicenter study conducted in university Hospital Antwerp (UZA) and ZNA Middelheim.
Tests are taken before and after one week IPV treatment. IPV is applied for 1 week during the physical therapy treatment of chronic obstructive pulmonary desease (COPD) patients admitted to the hospital for an excarebation. The IPV treatment is an additional treatment upon the standard treatment of the patients. The standard treatment consists out of existing drainage techniques to remove secretion out of the lungs by means of breathing control exercises. Patients are randomized into either the experimental group or the control group. The control group receives a standard physical therapy treatment without additional IPV treatment.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- intrapulmonary percussive ventilation, standard treatment
- Keywords
- COPD, IPV
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intrapulmonary percussive ventilationDevice
Also called IMP 2 by Breas Sweden
standard treatmentOther
Also called Autogenic drainge
breathing control exercises
| Study group | Role | What they receive |
|---|---|---|
| Intrapulmonary percussive ventilation | Experimental | IPV is applied for 1 week (once a day) during the physical therapy treatment of the patient Receives: Device: intrapulmonary percussive ventilation |
| standard airwy claerance regime | Active comparator | The standard treatment consists out of existing drainage techniques to remove secretion out of the lungs by means of breathing control exercises Receives: Other: standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung function testing
(spirometric , bodybox en diffusion) Performed in the lung function laboratory according to ERS standards using Jaeger 5.1 device vital capacity (VC), FEV1, FEV1/VC, peak expiratory flow (PEF), MMEF 75/25, MEF 50, MEF 25, MIF 50, RV, total lung capacity (TLC), functionale residual capacity (FRC), resistance, spec resistance, TCO, alveolar volume (VA), TCO/VA, Maximal inspiratory pressure, Maximal expiratory pressure
Measured: baseline and after one week
Secondary outcomes (1)
functional respiratory imaging
A 3D CT-scan is take. Images are uploaded into a software program for post processing 3D images are made and images are post processed
Measured: at baseline and after one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2012 (estimated)
- Study startSep 2011
- Primary completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- 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
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- Artesis University College, Antwerp, FLUIDDA nv
- Responsible party
- Principal investigator, Wilfried De Backer, University Hospital, Antwerp
- Investigators
- Wilfried De Backer, Phd, Principal investigator, UZA pneumology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01671540
- Sponsor's protocol ID
- PML_Kine_IPV
- Other IDs
- artesis_G018
- Acronym
- IPV
- Status last verified
- May 2015
- First submitted
- 20 Aug 2012
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Intrapulmonary Percussive Ventilation Using Functional Respiratory Imaging
- ClinicalTrials.gov ID
- NCT01671540
- Acronym / sponsor ID
- IPV / PML_Kine_IPV
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, IPV
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Collaborators
- Artesis University College, Antwerp, FLUIDDA nv
- Study start
- Sep 2011
- Primary completion
- Dec 2015 (estimated)
- First posted
- 23 Aug 2012 (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.
In this study the invetigators seek an answer on the following hypothesis:
- What are the long term effects of an IPV treatment evaluated with classical outcome parameters? (FEV1, Raw)
- Is the possible effect noticeable on the novel technique and is this comparable with the classical outcome parameters?
Detailed description
A Multicenter study conducted in university Hospital Antwerp (UZA) and ZNA Middelheim.
Tests are taken before and after one week IPV treatment. IPV is applied for 1 week during the physical therapy treatment of chronic obstructive pulmonary desease (COPD) patients admitted to the hospital for an excarebation. The IPV treatment is an additional treatment upon the standard treatment of the patients. The standard treatment consists out of existing drainage techniques to remove secretion out of the lungs by means of breathing control exercises. Patients are randomized into either the experimental group or the control group. The control group receives a standard physical therapy treatment without additional IPV treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intrapulmonary percussive ventilation | Experimental | Device: intrapulmonary percussive ventilationIPV is applied for 1 week (once a day) during the physical therapy treatment of the patient |
| standard airwy claerance regime | Active comparator | Other: standard treatmentThe standard treatment consists out of existing drainage techniques to remove secretion out of the lungs by means of breathing control exercises |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients admitted in the hospital for a acute exacerbation
- Mild to severe COPD
Key exclusion criteria (8 listed)
- Ischemic / ventricular aritmic
- Tracheotomise
- Pneumothorax
- Facial deformity
- Recent nose, mouth or ear operations
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 |
|---|---|---|
| intrapulmonary percussive ventilationAlso: IMP 2 by Breas Sweden | Device | Intrapulmonary percussive ventilation |
| standard treatmentAlso: Autogenic draingebreathing control exercises | Other | standard airwy claerance regime |
Primary outcome
Lung function testing
Time frame: baseline and after one week
(spirometric , bodybox en diffusion) Performed in the lung function laboratory according to ERS standards using Jaeger 5.1 device vital capacity (VC), FEV1, FEV1/VC, peak expiratory flow (PEF), MMEF 75/25, MEF 50, MEF 25, MIF 50, RV, total lung capacity (TLC), functionale residual capacity (FRC), resistance, spec resistance, TCO, alveolar volume (VA), TCO/VA, Maximal inspiratory pressure, Maximal expiratory pressure
1 secondary outcome
functional respiratory imaging
Time frame: at baseline and after one week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
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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.
Wilfried De Backer, Phd principal investigator
UZA pneumology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intrapulmonary percussive ventilation and standard treatment in people with Chronic Obstructive Pulmonary Disease, run by University Hospital, Antwerp 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 8 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 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kris Ides, Msc (036418267, kris.ides@artesis.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung function testing (time frame: baseline and after one week). 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 28 May 2015.