Effects of IPV Assessed With Functional Imaging (IPV)

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?

Study Overview

• Status: Unknown
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Device: intrapulmonary percussive ventilation; Other: standard treatment

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Antwerp
    • Edegem, Antwerp, Belgium, 2650
      • Recruiting
      • University Hospital Antwerp
      • Contact: Kris Ides, Msc; Phone Number: 0032 038213447; Email: kris.ides@artesis.be
      • Principal Investigator: Wilfried De Backer, Phd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Autogenic drainge

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
questionnaires	St george Borg MRC	1 week

Collaborators and Investigators

• Sponsor: University Hospital, Antwerp
• Collaborators: FLUIDDA nv; Artesis University College, Antwerp
• Investigators: Principal Investigator: Wilfried De Backer, Phd, UZA pneumology

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: August 20, 2012
• First Submitted That Met QC Criteria: August 22, 2012
• First Posted (Estimate): August 23, 2012

Study Record Updates

• Last Update Posted (Estimate): May 28, 2015
• Last Update Submitted That Met QC Criteria: May 27, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: COPD; IPV
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: PML_Kine_IPV; artesis_G018 (Other Identifier: artesis university college)