Effects of IPV Assessed With Functional Imaging
This study is currently recruiting participants.
Verified August 2012 by University Hospital, Antwerp
Sponsor:
University Hospital, Antwerp
Collaborators:
Artesis University College, Antwerp
FluidDA nv
Information provided by (Responsible Party):
Wilfried De Backer, University Hospital, Antwerp
ClinicalTrials.gov Identifier:
NCT01671540
First received: August 20, 2012
Last updated: August 22, 2012
Last verified: August 2012
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Purpose
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?
| Condition | Intervention |
|---|---|
|
Chronic Obstructive Pulmonary Disease |
Device: intrapulmonary percussive ventilation Other: standard treatment |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Evaluation of the Effects of Intrapulmonary Percussive Ventilation Using Functional Respiratory Imaging |
Resource links provided by NLM:
Further study details as provided by University Hospital, Antwerp:
Primary Outcome Measures:
- Lung function testing [ Time Frame: baseline and after one week ] [ Designated as safety issue: No ](spirometric , bodybox en diffusion) Performed in the lung function laboratory according to ERS standards using Jaeger 5.1 device VC, ESW, ESW/VC, PEF, MMEF 75/25, MEF 50, MEF 25, PIF, MIF 50, RV, TLC, FRC, resistance, spec resistance, TCO, VA, TCO/VA, MIP, MEP
Secondary Outcome Measures:
- functional respiratory imaging [ Time Frame: at baseline and after one week ] [ Designated as safety issue: No ]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
Other Outcome Measures:
- questionnaires [ Time Frame: 1 week ] [ Designated as safety issue: No ]St george Borg MRC
| Estimated Enrollment: | 20 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Intrapulmonary percussive ventilation
IPV is applied for 1 week (once a day) during the physical therapy treatment of the patient
|
Device: intrapulmonary percussive ventilation
Other Name: IMP 2 by Breas Sweden
|
|
Active Comparator: standard airwy claerance regime
The standard treatment consists out of existing drainage techniques to remove secretion out of the lungs by means of breathing control exercises
|
Other: standard treatment
breathing control exercises
Other Name: Autogenic drainge
|
Detailed Description:
A Multicenter study conducted in 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 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.
Eligibility| Ages Eligible for Study: | 30 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients admitted in the hospital for a acute exacerbation
- Mild to severe COPD
Exclusion Criteria:
- Ischemic / ventricular aritmic
- Tracheotomise
- Pneumothorax
- Facial deformity
- Recent nose, mouth or ear operations
- Recent gastric operations.
- Intubated
- Epilepsy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01671540
Contacts
| Contact: Kris Ides, Msc | 036418267 | kris.ides@artesis.be |
Locations
| Belgium | |
| University Hospital Antwerp | Recruiting |
| Edegem, Antwerp, Belgium, 2650 | |
| Contact: Kris Ides, Msc 038213447 ext 0032 kris.ides@artesis.be | |
| Principal Investigator: Wilfried De Backer, Phd | |
Sponsors and Collaborators
University Hospital, Antwerp
Artesis University College, Antwerp
FluidDA nv
Investigators
| Principal Investigator: | Wilfried De Backer, Phd | UZA pneumology |
More Information
No publications provided
| Responsible Party: | Wilfried De Backer, Prof. Dr., University Hospital, Antwerp |
| ClinicalTrials.gov Identifier: | NCT01671540 History of Changes |
| Other Study ID Numbers: | PML_Kine_IPV, artesis_G018 |
| Study First Received: | August 20, 2012 |
| Last Updated: | August 22, 2012 |
| Health Authority: | Belgium: |
Keywords provided by University Hospital, Antwerp:
|
COPD IPV |
Additional relevant MeSH terms:
|
Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on June 17, 2013