Effects of IPV Assessed With Functional Imaging

Chronic Obstructive Pulmonary Disease Clinical Trial

— IPV  

Official title:

Evaluation of the Effects of Intrapulmonary Percussive Ventilation Using Functional Respiratory Imaging

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01671540
• Other study ID #: PML_Kine_IPV
• Secondary ID: artesis_G018
• Status: Recruiting
• Phase: N/A
• First received: August 20, 2012
• Last updated: May 27, 2015
• Start date: September 2011

Study information

• Verified date: May 2015
• Source: University Hospital, Antwerp
• Contact: Kris Ides, Msc
• Phone: 036418267
• Email: kris.ides[@]artesis.be
• Is FDA regulated: No
• Health authority: Belgium:
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• intrapulmonary percussive ventilation

Other:
• standard treatment
breathing control exercises

Locations

Country	Name	City	State
Belgium	University Hospital Antwerp	Edegem	Antwerp

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Antwerp	Artesis University College, Antwerp, FLUIDDA nv

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	questionnaires	St george Borg MRC	1 week	No
Primary	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	No
Secondary	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	No