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Effects of IPV Assessed With Functional Imaging (IPV)

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
intrapulmonary percussive ventilation
standard treatment
Sponsored by
University Hospital, Antwerp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, IPV

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital AntwerpRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intrapulmonary percussive ventilation

standard airwy claerance regime

Arm Description

IPV is applied for 1 week (once a day) during the physical therapy treatment of the patient

The standard treatment consists out of existing drainage techniques to remove secretion out of the lungs by means of breathing control exercises

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 20, 2012
Last Updated
May 27, 2015
Sponsor
University Hospital, Antwerp
Collaborators
Artesis University College, Antwerp, FLUIDDA nv
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1. Study Identification

Unique Protocol Identification Number
NCT01671540
Brief Title
Effects of IPV Assessed With Functional Imaging
Acronym
IPV
Official Title
Evaluation of the Effects of Intrapulmonary Percussive Ventilation Using Functional Respiratory Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2011 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Antwerp
Collaborators
Artesis University College, Antwerp, FLUIDDA nv

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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?
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, IPV

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intrapulmonary percussive ventilation
Arm Type
Experimental
Arm Description
IPV is applied for 1 week (once a day) during the physical therapy treatment of the patient
Arm Title
standard airwy claerance regime
Arm Type
Active Comparator
Arm Description
The standard treatment consists out of existing drainage techniques to remove secretion out of the lungs by means of breathing control exercises
Intervention Type
Device
Intervention Name(s)
intrapulmonary percussive ventilation
Other Intervention Name(s)
IMP 2 by Breas Sweden
Intervention Type
Other
Intervention Name(s)
standard treatment
Other Intervention Name(s)
Autogenic drainge
Intervention Description
breathing control exercises
Primary Outcome Measure Information:
Title
Lung function testing
Description
(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
Time Frame
baseline and after one week
Secondary Outcome Measure Information:
Title
functional respiratory imaging
Description
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
Time Frame
at baseline and after one week
Other Pre-specified Outcome Measures:
Title
questionnaires
Description
St george Borg MRC
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kris Ides, Msc
Phone
036418267
Email
kris.ides@artesis.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wilfried De Backer, Phd
Organizational Affiliation
UZA pneumology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Antwerp
City
Edegem
State/Province
Antwerp
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kris Ides, Msc
Phone
038213447
Ext
0032
Email
kris.ides@artesis.be
First Name & Middle Initial & Last Name & Degree
Wilfried De Backer, Phd

12. IPD Sharing Statement

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Effects of IPV Assessed With Functional Imaging

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