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Effects of IPV Assessed With Functional Imaging (IPV)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2015 by Wilfried De Backer, University Hospital, Antwerp.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01671540
First Posted: August 23, 2012
Last Update Posted: May 28, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Artesis University College, Antwerp
FLUIDDA nv
Information provided by (Responsible Party):
Wilfried De Backer, University Hospital, Antwerp
  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
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Effects of Intrapulmonary Percussive Ventilation Using Functional Respiratory Imaging

Further study details as provided by Wilfried De Backer, University Hospital, Antwerp:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • functional respiratory imaging [ Time Frame: at baseline and after one week ]
    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 ]
    St george Borg MRC


Estimated Enrollment: 20
Study Start Date: September 2011
Estimated Primary Completion Date: December 2015 (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 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 ( Other Identifier: artesis university college )
First Submitted: August 20, 2012
First Posted: August 23, 2012
Last Update Posted: May 28, 2015
Last Verified: May 2015

Keywords provided by Wilfried De Backer, University Hospital, Antwerp:
COPD
IPV

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases