Effects of IPV Assessed With Functional Imaging

This study is currently recruiting participants. (see Contacts and Locations)
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
  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: December 2013
Estimated Primary Completion Date: December 2013 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: June 27, 2013
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 July 20, 2014