Effects of IPV Assessed With Functional Imaging

NCT01671540 | Unknown DMC

• 2 other identifiers: PML_Kine_IPVartesis_G018
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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?

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; IPV

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• functional respiratory imaging

  at baseline and after one week

Other Outcomes (1)

• questionnaires

  1 week

Study Arms (2)

Intrapulmonary percussive ventilation

EXPERIMENTAL

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

Device: intrapulmonary percussive ventilation

standard airwy claerance regime

ACTIVE COMPARATOR

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

Interventions

intrapulmonary percussive ventilation DEVICE

Also known as: IMP 2 by Breas Sweden

Intrapulmonary percussive ventilation

standard treatment OTHER

breathing control exercises

Also known as: Autogenic drainge

standard airwy claerance regime

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients admitted in the hospital for a acute exacerbation
• Mild to severe COPD

You may not qualify if:

• Ischemic / ventricular aritmic
• Tracheotomise
• Pneumothorax
• Facial deformity
• Recent nose, mouth or ear operations
• Recent gastric operations.
• Intubated
• Epilepsy

Sponsors & Collaborators

• University Hospital, Antwerp: lead
• Artesis University College, Antwerp: collaborator
• FLUIDDA nv: collaborator

Study Sites (1)

University Hospital Antwerp

Edegem, Antwerp, 2650, Belgium

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wilfried De Backer, Phd

  UZA pneumology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kris Ides, Msc

CONTACT

036418267; kris.ides@artesis.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: August 20, 2012
• First Posted: August 23, 2012
• Study Start: September 1, 2011
• Primary Completion: December 1, 2015
• Last Updated: May 28, 2015

Record last verified: 2015-05

Locations

BE (1)