Effects of IPV Assessed With Functional Imaging

This study is currently recruiting participants.
Verified June 2013 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: June 27, 2013
Last verified: June 2013

August 20, 2012
June 27, 2013
September 2011
December 2013   (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 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
Same as current
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 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.

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
December 2013
December 2013   (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
No
Contact: Kris Ides, Msc 036418267 kris.ides@artesis.be
Belgium
 
NCT01671540
PML_Kine_IPV, artesis_G018
Yes
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
June 2013

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