Effects of IPV Assessed With Functional Imaging

NCT ID: NCT01671540

Last Updated: 2015-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Brief Summary

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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

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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.

Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Intrapulmonary percussive ventilation

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

Group Type EXPERIMENTAL

intrapulmonary percussive ventilation

Intervention Type DEVICE

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

Group Type ACTIVE_COMPARATOR

standard treatment

Intervention Type OTHER

breathing control exercises

Interventions

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intrapulmonary percussive ventilation

Intervention Type DEVICE

standard treatment

breathing control exercises

Intervention Type OTHER

Other Intervention Names

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IMP 2 by Breas Sweden Autogenic drainge

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Artesis University College, Antwerp

OTHER

Sponsor Role collaborator

FLUIDDA nv

INDUSTRY

Sponsor Role collaborator

University Hospital, Antwerp

OTHER

Sponsor Role lead

Responsible Party

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Wilfried De Backer

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wilfried De Backer, Phd

Role: PRINCIPAL_INVESTIGATOR

UZA pneumology

Locations

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University Hospital Antwerp

Edegem, Antwerp, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Kris Ides, Msc

Role: CONTACT

036418267

Facility Contacts

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Kris Ides, Msc

Role: primary

038213447 ext. 0032

Other Identifiers

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artesis_G018

Identifier Type: OTHER

Identifier Source: secondary_id

PML_Kine_IPV

Identifier Type: -

Identifier Source: org_study_id

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