Effects of IPV Assessed With Functional Imaging

Not Applicable

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Device: intrapulmonary percussive ventilation; Other: standard treatment

• Registration Number: NCT01671540
• Lead Sponsor: University Hospital, Antwerp

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.

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2012-08-20
• Study First Submitted QC: 2012-08-22
• Study First Posted: 2012-08-23
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-27
• Last Update Posted: 2015-05-28
• Primary Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intrapulmonary percussive ventilation	intrapulmonary percussive ventilation	IPV is applied for 1 week (once a day) during the physical therapy treatment of the patient
standard airwy claerance regime	standard treatment	The standard treatment consists out of existing drainage techniques to remove secretion out of the lungs by means of breathing control exercises

Primary Outcome Measures

Name	Time	Method
Lung function testing	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

Name	Time	Method
functional respiratory imaging	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

Trial Locations

Locations (1)

University Hospital Antwerp; 🇧🇪 Edegem, Antwerp, Belgium