Effects of IPV Assessed With Functional Imaging

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of the Effects of Intrapulmonary Percussive Ventilation Using Functional Respiratory Imaging

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Device: intrapulmonary percussive ventilation
* Other: standard treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intrapulmonary percussive ventilation<br>IPV is applied for 1 week (once a day) during the physical therapy treatment of the patient | Device: intrapulmonary percussive ventilation<br> <br> * Other names: IMP 2 by Breas Sweden;|
| Active Comparator: standard airwy claerance regime<br>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<br>* breathing control exercises<br>* Other names: Autogenic drainge;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | baseline and after one week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | at baseline and after one week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, IPV