Effects of IPV Assessed With Functional Imaging (IPV)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by University Hospital, Antwerp
Sponsor:
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: May 27, 2015
Last verified: May 2015

August 20, 2012
May 27, 2015
September 2011
December 2015   (final data collection date for primary outcome measure)
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 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
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
Complete list of historical versions of study NCT01671540 on ClinicalTrials.gov Archive Site
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
Same as current
questionnaires [ Time Frame: 1 week ] [ Designated as safety issue: No ]
St george Borg MRC
Same as current
 
Effects of IPV Assessed With Functional Imaging
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?

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease
  • Device: intrapulmonary percussive ventilation
    Other Name: IMP 2 by Breas Sweden
  • Other: standard treatment
    breathing control exercises
    Other Name: Autogenic drainge
  • Experimental: Intrapulmonary percussive ventilation
    IPV is applied for 1 week (once a day) during the physical therapy treatment of the patient
    Intervention: Device: intrapulmonary percussive ventilation
  • 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
    Intervention: Other: standard treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
Not Provided
December 2015   (final data collection date for primary outcome measure)

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
Both
30 Years and older   (Adult, Senior)
No
Contact: Kris Ides, Msc 036418267 kris.ides@artesis.be
Belgium
 
NCT01671540
PML_Kine_IPV, artesis_G018
Yes
Not Provided
Not Provided
Wilfried De Backer, University Hospital, Antwerp
University Hospital, Antwerp
  • Artesis University College, Antwerp
  • FLUIDDA nv
Principal Investigator: Wilfried De Backer, Phd UZA pneumology
University Hospital, Antwerp
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP